Vilobelimab - InflaRx
Alternative Names: CaC-P29; Gohibic; IFX-1; Vilobelimab-InflaRxLatest Information Update: 16 Apr 2024
At a glance
- Originator InflaRx
- Class Anti-infectives; Anti-inflammatories; Antineoplastics; Antivirals; Monoclonal antibodies; Skin disorder therapies; Vascular disorder therapies
- Mechanism of Action Complement C5a inhibitors
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Orphan Drug Status
Yes - Pyoderma gangrenosum
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Registered COVID-19 pneumonia
- Phase III Pyoderma gangrenosum
- Phase II Hidradenitis suppurativa; Squamous cell cancer
- Suspended Granulomatosis with polyangiitis; Microscopic polyangiitis
- No development reported Inflammation
- Discontinued Sepsis; Systemic inflammatory response syndrome
Most Recent Events
- 16 Apr 2024 InflaRx plans a phase III trial for Adult respiratory distress syndrome (InflaRx Pipeline, April 2024)
- 11 Oct 2023 Updated efficacy and adverse events data from the phase II/III PANAMO trial in Pneumonia presented at the IDWeek 2023 (IDW-2023)
- 31 Aug 2023 Preregistration for COVID-19 pneumonia in European Union (IV)
Development Overview
Introduction
Vilobelimab (IFX 1; CaCP 29), is an anti-complement C5a monoclonal antibody, that is being developed by InflaRx for the treatment of COVID-2019 pneumonia, hidradenitis suppurativa, pyoderma gangraenosum, microscopic polyangiitis, Wegener's granulomatosis and cutaneous squamous cell cancer. It was also being developed previously for treatment of sepsis, systemic inflammatory response syndrome. Vilobelimab targets complement and was identified from a research programme aimed at the development of specific monoclonal antibodies targeted to activation products of the complement pathway, such as C3a, C5a and the terminal membrane attack complex. Vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, unlikely for other molecules blocking the cleavage of C5. Vilobelimab is commercially available for hospitals in the US under EUA for the treatment of severe COVID-19 pneumonia (critically ill, intubated, mechanically ventilated COVID-19 patients). Vilobelimab is under regulatory review in EU for COVID-2019 infections. Clinical development of intravenous formulation for the treatment of COVID-19 pneumonia, hidradenitis suppurativa, pyoderma gangraenosum, sepsis, systemic inflammatory response syndrome, microscopic polyangiitis, squamous cell cancer and Wegener's granulomatosis is underway worldwide. Clinical development for sepsis, systemic inflammatory response syndrome was underway. Preclinical development of subcutaneous formulation of vilobelimab for the treatment of hidradenitis suppurativa is underway in Germany.
As of May 2023, the company is actively looking for partnership opportunities for the further development of the candidate [1] .
In May 2022, InflaRx decided to halt the phase III trial in hidradenitis suppurativanot and not to advance vilobelimab in microscopic polyangiitis and granulomatosis with polyangiitis (ANCA-associated vasculitis) for the time being to prioritise the best use of their resources [2]
Phase I development in inflammation was conducted in Germany, but no recent development was reported.
As at June 2021, InflaRx does not plan to continue further development of vilobelimab for treatment of sepsis [3] .
As at June 2021, InflaRx does not plan to continue further development of vilobelimab for treatment of systemic inflammatory response syndrome due to complex cardiac surgery [3] .
Vilobelimab has emerged from a research programme for anti-sepsis monoclonal antibodies by Beijing Mabworks and InflaRx [see AdisInsight drug profile 800029865].
As at June 2023, no recent reports of development had been identified for preclinical development in Hidradenitis suppurativa in Germany (SC).
Company Agreements
In May 2023, InflaRx entered into a manufacturing agreement with WuXi Biologics for vilobelimab. According to the terms of the agreement, WuXi Biologics will provide cGMP manufacturing of vilobelimab. [4]
In December 2022, InflaRx, amended its already existing co-development agreement with Staidson (Beijing) BioPharmaceuticals (together with its affiliates, STS) to support STS in its regulatory approval efforts for BDB 1 in China. Through the amendment of the existing co-development agreement, InflaRx will receive royalties of 10% on net sales of BDB 1 for the treatment of COVID-2019 in China. InflaRx has granted STS an exclusive license for use in China to certain of InflaRx’s clinical, manufacturing and regulatory documentation regarding vilobelimab in order to support and facilitate the regulatory filing for BDB 1 for the treatment of severely ill COVID-2019 patients with the Chinese National Medical Products Administration (NMPA). Earlier in December, 2015, InflaRx entered into a co-development agreement with Beijing Defengrei Biotechnology Co. Ltd., or BDB, for the use of the IFX-1 technology and cell line in BDB’s development of drug candidates for sale in China. Under the terms of the agreement, InflaRx granted BDB an exclusive, non-transferable license to use the IFX-1 cell line and related intellectual property solely to develop and commercialise BDB’s drug candidates, including BDB-1, in China. InflaRx is entitled to receive royalties on net sales of BDB’s products containing BDB-1 and reserves the right to commercialise products containing BDB-1 outside of China. [5] [6]
As of April 2020, InflaRx and Merck enters into clinical collaboration agreement to evaluate combination of vilobelimab (IFX-1) with pembrolizumab in patients with an undisclosed tumor type. Under the terms of the agreement, InflaRx will conduct a Phase IIa clinical trial with two vilobelimab arms, including one with pembrolizumab. [7]
Key Development Milestones
Adult respiratory distress syndrome
As of April 2024, InflaRx announced its intention to initiate a phase III trial for adult respiratory distress syndrome (InflaRx Pipeline, April 2024).
COVID-19 pneumonia
In June 2023, InflaRx announced that vilobelimab (Gohibic) is commercially available for hospitals in the US for the treatment of critically ill Covid-19 patients under Emergency Use Authorization (EUA). In April 2023, vilobelimab received an Emergency Use Authorization (EUA) by the US FDA for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). The data supporting the EUA were based on the previously announced results of the multicenter Phase III PANAMO trial [see below]. As of June 2023, InflaRx is continuing discussions with the US FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of vilobelimab [8] [9] .
In August 2023, InflaRx announced submission of a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) and that the European Medicines Agency (EMA) has validated the MAA. The application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU). The MAA submission is based on the previously announced results of the multicenter phase III PANAMO trial [see below] [10] . Previously, in June 2023, InflaRx announced intention to submit marketing authorization application to European Medicines Agency (EMA) for COVID-19 pneumonia and the completion of meetings with the member state teams of the European Committee for Medicinal Products for Human Use (CHMP) related to MAA with the European Medicines Agency [9] .
In September 2022, InflaRx submitted a request for Emergency Use Authorisation (EUA) for vilobelimab based on the results of the phase III PANAMO trial [see below] conducted in invasively mechanically ventilated, critically ill COVID-19 patients [covid-19 pneumonia in development table]. The request was submitted following encouraging interactions with the US FDA at a Type B meeting held earlier. As of September 2022, US FDA conditionally accepts 'Gohibic' as the proprietary name for vilobelimab [11] [12] .
In September 2022, Vilobelimab was granted Fast Track designation from the US FDA for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients [covid-19 pneumonia in development table]. The Fast Track designation was based on the results of the phase III PANAMO trial[see below] [11] .
In December 2021, InflaRx completed the phase II/III PANAMO study, that was designed to assess the efficacy of vilobelimab in patients with severe COVID-19 pneumonia (EudraCT2020-001335-28; NCT04333420; IFX-1-P2.9). The randomised, double blinded, placebo controlled phase III part of the trial was initiated in September 2020 and completed its enrolment of 399 early intubated, critically ill patients in October 2021 in Belgium, Brazil, France, Germany, Mexico, the Netherlands, Peru, Russia and South Africa. The company also reported the receipt of regulatory approval from the Paul-Ehrlich-Institut, to conduct the study in Germany. The phase II part of the trial was initiated in March 2020 and enrolled 30 patients. The relative percentage change from baseline to day 5 in the oxygenation index (PaO2 / FiO2) is defined primary end point of the trial [13] [14] . In April 2020, InflaRx dosed the first patient with vilobelimab with severe COVID-19 pneumonia in the Netherlands [15] [16] [5] . In June 2020, safety and efficacy results from the trial were released by the company. The company also announced that the independent data safety monitoring board recommended continuation of the trial into the phase III part after reviewing adverse events from the trial [17] . Accordingly, the first patient was enrolled in phase III part of the trial in Spetember 2020 [3] . In June 2020, efficacy results from the trial were released by the company. In March 2022, InflaRx released efficacy data from a phase II/III trial. The company plans to discuss the data from the trial with a regulatory authority to determine potential steps in the advancement of the drug in COVID-19 penumonia. In May 2022, results from this trial were released by InflaRx [18] [19] [20] [2] . In October 2022, updated efficacy and safety data from the trial were presented at the IDWeek 2022 (IDW-2022) [21] . In October 2023, updated efficacy and safety data from the trial were presented at the IDWeek 2023 (IDW-2023) [22]
Hidradenitis suppurativa (HS)
In March 2022, InflaRx received a corrected advice letter from the US Food and Drug Administration (FDA) related to its phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). In the letter the US FDA no longer recommends the use of Hidradenitis suppurativa Clinical Response Score (HiSCR) as the primary endpoint in the trial. The letter, however, recommends the use of modified HiSCR [23] [24] .In February 2022, InflaRx reported that the Company has received an advice letter from the US FDA related to its phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). The feedback indicates that the FDA recommends using the Hidradenitis suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint in the phase III trial. The FDA advice was provided nearly three months after the Company’s protocol submission and contrasts with the FDA advice provided to the Company in a Type A meeting held in Q3 2021. In the minutes of that meeting, FDA provided advice on how to implement, name and validate the meaningfulness of the modified HiSCR, a new primary endpoint suggested by the Company, that would measure the reduction of all three types of inflammatory lesions in HS – inflammatory nodules, abscesses and draining tunnels. Following the advice received in the Type A meeting, earlier this year, InflaRx announced the initiation of a Phase III trial, designed to study patients with moderate to severe HS disease suffering from actively draining tunnels. Given the unexpected details of the feedback from the FDA, InflaRx will pause activities related to the Phase III trial. The Company will seek to clarify the advice received and determine next steps, which will be communicated accordingly. The FDA has not issued a clinical hold. InflaRx incorporated the FDA’s input and submitted the phase III protocol to the agency in late November 2021. The FDA had no comments during the 30-day nor the 60-day review period. In Q1 2022, InflaRx determined it was appropriate to begin study activities, as the Company did not expect any critical protocol review issues to be pending with FDA [25] .
In May 2022, InflaRx temporary suspended the this phase III trial to prioritise the best use of our resources. In Janaury 2021, InflaRx initiated a phase III trial with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. Company incorporated the feedback and submitted the phase III protocol to the Agency in late November 2021. The FDA had no comments during the 30-day review period; so, InflaRx initiated the study, including bringing on clinical sites. The primary endpoint of the trial is modified HiSCR (Hidradenitis Suppurativa Clinical Response), as suggested by the FDA, will include measuring the reduction of all three types of lesions – inflammatory nodules, abscesses and draining tunnels. Enrollment is expected to start in Q2 2022 [26] [2]
In September 2021, InflaRx completed type A meeting with US FDA. The FDA response was supportive of a pivotal study program that focuses on patients with active draining tunnels and a new primary efficacy endpoint that will include measuring the reduction of all three lesions - inflammatory nodules, abscesses and draining tunnels. InflaRx will incorporate FDA feedback in the study protocol for its pivotal program and submit the protocol in Q4 2021 with study activities to begin post approval by FDA [27] .
As of March 2021, InflaRx has submitted a Special Protocol Assessment (SPA) to the US FDA for the planned phase III programme of vilobelimab for the treatment of hidradenitis suppurativa. The US FDA agreed to the dosing regimen in the protocol but did not agree with the assessment of the primary endpoint using the International Hidradenitis Suppurativa Severity Score (IHS4). At the US FDA's suggestion, the company plans to request a Type A meeting to discuss the primary endpoint measure in detail [20] [28] . In June 2020, InflaRx completed an end-of-Phase II meeting with the US FDA regarding a phase III programme for the treatment of hidradenitis suppurativa. The US FDA agreed with InflaRx on proposals which will support submission of biologics license application (BLA), including vilobelimab dosing, target study population, and the nonclinical and clinical pharmacology packages [29] [30] .
In July 2020, InflaRx received feedback for earlier requested scientific advice from the EMA related to the European regulatory approval pathway for vilobelimab. The EMA conceded that the the HiSCR response does not validate the clinical relevance of a reduction in draining fistulas and recommended to replace it with IHS4 as tool to evaluate the efficacy for HS. InflaRx is now working diligently to address the feedback received in Scientific Advice from the European Medicines Agency and analyzing the strategy for its phase III development program for the use of IFX-1 in the treatment of HS [29] [30] .
InflaRx in July 2019, reported that the phase IIb SHINE trial did not meet the primary endpoint of a dose dependent drug effect on Hidradenitis Suppurativa Clinical Response Score (HiSCR) [31] . In January 2020, InflaRx, in collaboration with Quintiles, completed the trial that evaluated the dose-response signal of vilobelimab at week 16, in patients with moderate or severe hidradenitis suppurativa (EudraCT2017-004501-40; NCT03487276; IFX1P2-4). In March 2018, the company enrolled first patient in the trial. The randomised, double-blind, placebo-controlled trial, initiated in February 2018, enrolled 179 patients in the US, Bulgaria, Canada, Denmark, France, the Netherlands, Greece, Germany and Poland [32] . C5a levels were significantly elevated in HS patients, compared with healthy volunteers. Also, elevated C5a levels in HS patients were dose-dependently suppressed by vilobelimab [33] . The company has intended to extend the study to a 28-week open-label extension (OLE) phase to assess long-term efficacy and safety. Additional objectives include the evaluation of safety and tolerability of vilobelimab as well as an assessment of additional efficacy and patient-reported outcome parameters [34] . In November 2019, InflaRx reported sustained improvement in inflammatory lesion count at week 40 compared to baseline counts of the OLE treatment group on day 1 of the SHINE study [7] . Earlier, in January 2018, the US FDA accepted IND application filed for the trial [35] [36] . In November 2018, company reported that enrolment in the trial was completed [37] .
In July 2017, InflaRx completed a phase IIa trial that evaluated the safety and efficacy of intravenous vilobelimab, administered over 8 weeks, in patients with moderate to severe hidradenitis suppurativa (IFX-1-P2.3; EudraCT2016-002988-33; NCT03001622). The open-label trial, initiated in November 2016, enrolled 12 patients, who were ineligible for or failed previous therapies with biologicals, in Greece. Top-line data from the trial were released in September 2017 [36] [38] .
In May 2019, InflaRx reported that preclinical development was underway, for a subcutaneous formulation of vilobelimab, for the treatment of hidradenitis suppurativa. The company intends to potentially explore this formulation in other indications [39] .
Inflammation
Vilobelimab is in phase I development for viral inflammation (InflaRx pipeline, June 2019).
Microscopic Polyangiitis and Granulomatosis with Polyangiitis (ANCA-associated vasculitis)
In May 2022, InflaRx decided not to advance vilobelimab in microscopic polyangiitis and granulomatosis with polyangiitis (ANCA-associated vasculitis) for the time being to prioritise the best use of their resources [2]
In March 2022, InflaRx announced the plans to meet with the US FDA this year, for discussion regarding a pivotal design in microscopic polyangiitis [23] .
In June 2021, InflaRx announced plans to apply for Orphan Drug designation for status in ANCA-associated vasculitis in USA and in Europe, upon obtaining data from the ongoing phase II trials [see below] [3] .
In May 2022, InflaRx terminated phase II IXPLORE trial due to COVID-19 pandemic outbreak and its impact on overall study activities. In May 2021, InflaRx announced that phase II IXPLORE trial to investigate the safety and tolerability of two dose regimens of vilobelimab as add-on to standard of care (SOC) in subjects with granulomatosis with polyangiitis and microscopic polyangiitis compared with placebo (NCT03712345; IFX-1-P2.6) met its primary endpoints evaluating the safety of vilobelimab and was not powered to show statistical significance on efficacy endpoints [40] [7] . In May 2021, InflaRx completed the phase II IXPLORE trial. In May 2020, the company had reinitiated the trial as previously, in April 2020, it had suspended the trial enrolment based on a blinded interim analysis and potential impact of the COVID-19 pandemic. The trial was initiated in October 2018 and enrolled 19 patients in US and Canada [41] . Previously, it was planned that approximately 36 patients would be enroled, however after a blinded interim analysis was conducted and an assessment of the potential impact of the COVID-19 pandemic, it was decided to finalise the trial enrollment at 19 patients. Earlier in June 2018, IND application for the trial was approved by US FDA. In October 2018, company reported that the first patient was dosed [3] [42] [37] [39] [43] .
In June 2021, InflaRx completed the phase II IXCHANGE trial that evaluated the efficacy of vilobelimab treatment as a replacement for glucocorticoids therapy in patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) diseases (IFX1P2-5; EudraCT2018-000768-27; NCT03895801). The double-blind, randomised trial was initiated in April 2019 and enrolled 57 patients in Czech Republic, France, Germany, Russia, Italy, Sweden, the Netherlands, Spain, the UK, Switzerland, Sweden, Denmark and Belgium. Originally, the trial planned to enroll 80 patients, however, after analysing the impact of ongoing COVID-19 pandemic on the study in May 2020, a blinded interim analysis of part 1 was conducted by an independent Data Monitoring Committee. Based on this analysis, part 2 of the study was continued with decreased the number of enrolled patients. Both part 1 and part 2 of the study are fully enrolled [3] [42] . In Part 1, patients were randomised to receive either vilobelimab plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. In Part 2 of the study, patients will be randomised to receive vilobelimab plus placebo glucocorticoids versus placebo plus a standard dose of glucocorticoids. Patients in both arms will receive the standard of care dosing of immunosuppressive therapy (rituximab or cyclophosphamide). The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16. Earlier in December 2018, the European regulatory authorities approved the Investigational Medicinal Product Dossier (IMPD) for initiation of the phase II study in patients with ANCA-associated vasculitis in Europe [44] [45] [46] . In August 2019, results form the trial were released by the company. The trial results showed multiple efficacy signals which were not reflected by the HiSCR. The number of draining fistulas was significantly reduced by week 16 in the high-dose group when compared to the placebo group. Further, using the International HS Severity Score System, IHS-4, which takes into account all lesions, a statistically significant reduction was seen in the high-dose group, when compared to the placebo group [16] [42] . In December 2020, InflaRx completed enrollment in European phase II IXCHANGE trial in ANCA-associated vasculitis [47] . In November 2022, the company presented efficacy and safety data from the trail at the American College of Rheumatology 2022 (ACR-2022) [48] .
Pyoderma Gangraenosum
In July 2022, US FDA granted fast track designation for vilobelimab in the treatment of ulcerative pyoderma gangrenosum (PG). Company submitted a request for fast track designation to the FDA on the basis of positive outcome data in PG from phase-IIa trial [49] .
In June 2022, InflaRx announced that vilobelimab has been granted orphan drug designation for the treatment of pyoderma gangraenosum by both the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe [50] .
In August 2023, InflaRx initiated a phase III trial to evaluate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum (NCT05964413; IFX-1-P3.4). The randomized, double-blind, placebo-controlled, multicenter, adaptive trial intends to enrol approximately 90 patients in the US, Europe and Australia [51] . As of March 2023, InflaRx had submitted the clinical trial protocol to the FDA [52] . In January 2023, InflaRx had announced the design of the trial to be conducted in USA, Europe and other countries [53] [54] . In November 2023, InflaRx announced dosing of first patient in the trial [55] .
In August 2022, InflaRx reported that it had a productive end-of-Phase II meeting with the US FDA. The FDA indicated its support for a randomised, controlled program during the meeting and offered to review the study protocol, recognising pyoderma gangrenosum as a serious and rare condition. Based on the FDA’s feedback and recommendations, InflaRx is finalising the design for a phase III trial [56] .
In January 2022, InflaRx completed a phase IIa trial that evaluated the safety and efficacy of vilobelimab in patients with pyoderma gangrenosum (NCT03971643; IFX-1-P2.7; EudraCT2020-003273-21). Earlier, the Health Canada had approved the initiation of the trial and the first patient was dosed in June 2019. In February 2020, the company announced the positive initial data from the first five patients in the lowest dose group treated with vilobelimab. The open-label trial, initiated in May 2019, completed enrolment of 19 patients in the US, Canada and Poland [57] [39] [7] [58] [59] . In August 2021, additional positive data from the first 10 evaluated patients of the trial released by InflaRx [60] . In October 2021, updated efficacy and safety data from the trial were released by InflaRx. In May 2022, results from this trial were released by the InflaRx [61] [2]
As at May 2019, vilobelimab was undergoing phase I development in this indication (InflaRx pipeline, May 2019).
Sepsis
As at June 2021, InflaRx announced that despite the positive observations from the clinical trial in Sepsis, the company now intends to focus on Hidradenitis suppurativa and ANCA-associated vasculitis for further development, and not on Sepsis, owing to the historically increased risk and uncertainty relating to clinical development for product candidates within the sepsis indication [3] .
The primary endpoints were met in the phase II SCIENS trial completed in January 2016, that evaluated the safety, pharmacokinetics and pharmacodynamics of vilobelimab in patients with early or newly developing abdominal or pulmonary derived septic organ dysfunction (IFX1P2-1; NCT02246595; EudraCT2013-001037-40). The randomised, placebo-controlled, double-blind study initiated in December 2013 enrolled 72 patients in Germany [62] [63] . Positive data were reported in January 2016, and indicated that vilobelimab dose-dependently and significantly reduced and suppressed inflammatory complement pathwayC5a [64] . In June 2021, safety and pharmacodynamics data from the trial was released by InflaRx [3] .
Systemic inflammatory response syndrome
As at June 2021, InflaRx announced that based on the clinical observations from the phase II CARDIAC trial, the company has decided to discontinue the development in complex cardiac surgery [3] .
In January 2017, InflaRx completed the phase II CARDIAC trial which evaluated whether the prophylactic treatment with vilobelimab protects patients from severe systemic inflammation and subsequent organ dysfunction and to evaluate the clinical efficacy, safety, and pharmacokinetic parameters, in patients undergoing complex cardiac surgery (IFX-1-P2.2; EudraCT2015-003036-12; NCT02866825). The primary end point was the reduction of interleukin (IL)-6 levels. The randomised, double-blind trial initiated in June 2016, enrolled 116 patients in Germany (InflaRx pipeline, March 2016). Prior to June 2021, the company released the results from the trial [65] .
InflaRx has completed a phase I clinical trial with vilobelimab. The trial reached its endpoints, showing that the drug was safe and well-tolerated with desirable pharmacodynamic and pharmacokinetic parameters [66] . InflaRx initiated the phase I trial in March 2011 (NCT01319903). The trial enrolled 26 subjects in Germany [67] .
Squamous cell cancer
In January 2021, InflaRx initiated a phase II trial to assess the safety, tolerability and antituomur activity and to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of vilobelimab as a monotherapy or in combination with pembrolizumab in patients with PD-1 or PD-L1-resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (EudraCT2020-000864-42; NCT04812535; IFX1P2-8). The open-label trial intends to enrol approximately 70 patients in France, Germany, the US, Belgium, and Spain. The trial consists of two arms, Arm A (monotherapy) and Arm B (combination therapy). First patient was enrolled by June 2021. In February 2022, InflaRx reported that the three patients enrolled in the first dosing cohort were treated for 36 days without any safety concerns. As of August 2022, Nine patients were enrolled in Arm A. The Arm B of the trial has enrolled nine patients so far in the first two dose groups. As of March 2023, , 10 patients have been recruited into Arm A of the study and 14 patients have been recruited in Arm B of the study [56] [23] [68] [69] [70] [52] .
Wegener's granulomatosis
In African green monkeys, vilobelimab reduced acute lung injury and systemic inflammatory response syndrome, induced by H7N9 virus infections [71] .
Preclinical studies
Vilobelimab has been demonstrated in pre-clinical studies to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response [50] .
Financing information
In April 2023, InflaRx announced the pricing of its underwritten public offering of 9,411,765 ordinary shares at an offering price of $US4.25 per ordinary share. The offering is expected to close on April 14, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering to fund the continued development of vilobelimab, other development expenses and general corporate purposes [72] .
In October 2021, InflaRx was awarded a grant of approximately $US50.7 million (EUR 43.7 million) from German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of severely ill, mechanically ventilated COVID-19 patients. Initial tranche amounts to approximately EUR 25.8 million and the remainder grant will be awarded in three subsequent tranches. The tranches will be granted after reaching the prespecified milestones. As at December 2021, the company has received EUR 8.3 million of this grant funding. As of December 2022, InflaRx has received €25.6 million in grant funds and still has a maximum amount of €15.9 million available for claiming under the grant throughout the end of the grant term in June 2023 [23] [73] [52] .
In March 2021, InflaRx completed underwritten offering of common shares and one year warrants obtaining gross proceed of approximately $US75 million. Earlier in February 2021, the company had announced the proposed underwritten offering of common shares and one year warrants. The company intends to use proceeds for the research and development for clinical and preclinical research and development activities and for working capital and general corporate purposes [74] [75] [76] .
In June 2019, InflaRx raised $US62.9 million in a follow-on offering to advance clinical programs for vilobelimab [77] . In June 2019, InflaRx announced plans to raise funds through public offerings of shares of its common stock. The funds will be used to conduct a phase IIb clinical trial for vilobelimab in HS patients, a phase II clinical development program for vilobelimab in AAV patients. The proceeds will also be used to fund first clinical phase II development in two additional neutrophil-driven indications within the autoimmune and inflammatory disease area, for research and development activities, as well as for working capital and other general corporate purposes [78] .
In July 2016, InflaRx reported the closing of a €31 million series C financing, which will be used to advance clinical phase II development of vilobelimab and the preclinical development of the follow-up pipeline-molecules [62] .
InflaRx has completed three milestone-driven tranches of series A financing [79] [80] .
Patent Information
As of December 31, 2022, the company owned nine issued U.S. patents and five pending U.S. non-provisional patent applications, 29 issued foreign patents, including four granted European patents validated in 88 countries and one granted Eurasian Patent validated in nine countries, as well as 80 foreign patent applications, including four European patent applications and five Eurasian patent applications covering C5a inhibitors and associated methods of use [1] .
As of December 31, 2022, the company owned one U.S. patent application and 15 foreign patent applications, including an EP patent application covering an improved C5a specific antibody. If issued, the U.S. and foreign patents are expected to expire in 2041, excluding any additional term for patent term adjustments or patent term extensions [1] .
As of December 31, 2022, the company owned one pending U.S. non-provisional patent application and 15 foreign patent applications, including one EP patent application covering the use of inhibitor of C5a activity, for example vilobelimab, for treating Corona viral diseases. If issued, the U.S. and foreign patents based on the application under the PCT are expected to expire in 2040, excluding any additional term for patent term adjustments or patent term extensions [1] .
As of December 31, 2022, the company owned four issued U.S. patents covering the composition of matter of antibodies that block C5a and their use in blocking C5a-induced biological effects in patients with diseases that involve acute or chronic inflammation, which would include in their scope HS and AAV. In addition, the company owned 20 issued foreign patents, including two granted European patents validated in 74 countries and one Eurasian Patent validated in nine countries, two pending foreign patent applications, including one pending European patent application, covering the composition of matter of antibodies that block C5a and their use in the treatment of various diseases that involve acute or chronic inflammation, which would include in their scope HS and AAV, and, depending on the jurisdiction of the applicable patent, specifically cover the use of such antibodies in treating diseases such as ischemia and reperfusion related injuries, acute lung injury and pneumonia. The issued U.S. and foreign patents are expected to expire in 2030, excluding any additional term for patent term adjustments or patent term extensions. If issued, the pending U.S. and foreign patents are expected to expire in 2030, excluding any additional term for patent term adjustments or patent term extensions [1] [81] [82] [3] .
As of December 31, 2022, InflaRx owned two granted U.S. patents and four granted foreign patents, including one EP patent validated in three countries and one foreign patent application covering the use of certain binding moieties, such as antibodies, that inhibit C5a for the treatment of viral pneumonia. The U.S. and foreign patents are expected to expire in 2035, excluding any additional term for patent term adjustments or patent term extension. If issued, the pending foreign patent is expected to expire in 2035, excluding any additional term for patent term adjustments or patent term extensions [1] [3] .
As of December 31, 2022, InflaRx owned two granted U.S. patents, two pending U.S. non-provisional patent applications, five granted foreign patents, including one European patent validated in 11 countries, 29 pending foreign patent applications, including two pending European patent applications covering the use of an inhibitor of C5a activity, for example, vilobelimab, for treating HS and other cutaneous, neutrophilic inflammatory diseases. The issued U.S. and foreign patents are expected to expire in 2038, excluding any additional term for patent term adjustments or patent term extensions. If issued, the pending foreign patent is expected to expire in 2038, excluding any additional term for patent term adjustments or patent term extensions [1] [3] .
As of December 2020, InflaRx has one pending US non-provisional patent application and one patent application under the PCT covering inhibitors of C5aR (PCT/EP2020/053171; WO2020182384A1; US20200290969A1) [83] [3] .
As of December 2020, InflaRx has one European application covering an improved C5a specific antibody [3] .
As of December 2020, InflaRx has one pending application under the PCT covering the use of inhibitor of C5a activity, for example vilobelimab, for treating corona viral diseases [3] .
Drug Properties & Chemical Synopsis
- Route of administration IV, SC
- Formulation Infusion, unspecified
- Class Anti-infectives, Anti-inflammatories, Antineoplastics, Antivirals, Monoclonal antibodies, Skin disorder therapies, Vascular disorder therapies
- Target Complement C5a
- Mechanism of Action Complement C5a inhibitors
-
WHO ATC code
D11 (Other Dermatological Preparations)
J01X (Other Antibacterials)
L01F (Monoclonal antibodies and antibody drug conjugates)
L04 (Immunosuppressants)
M01A (Antiinflammatory and Antirheumatic Products, Non-steroids)
R07A (Other Respiratory System Products)
-
EPhMRA code
D11 (Other Dermatological Preparations)
J1X (Other Antibacterials)
L1G (Monoclonal Antibody Antineoplastics)
L4 (Immunosuppressants)
M1 (Anti-Inflammatory and Anti-Rheumatic Products)
R7 (Other Respiratory System Products)
- Chemical name Immunoglobulin G4, anti-(human complement C5a) (human-mus musculus monoclonal IFX-1 gamma4-chain), disulfide with human-mus musculus monoclonal IFX-1 kappa-chain, dimer
- Molecular formula C6456 H9976 N1716 O2054 S44
- CAS Registry Number 2250440-41-4
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
Hidradenitis suppurativa |
Outcome Measure |
C5 |
|
|
inflammation |
Eligibility Criteria |
C-reactive protein (CRP) |
|
|
inflammation |
Outcome Measure |
Interleukin-8 (IL-8) Interleukin-6 (IL-6) C5 |
|
|
sepsis |
Eligibility Criteria |
Interleukin-6 (IL-6) C-reactive protein (CRP) |
|
|
sepsis |
Outcome Measure |
Tumor necrosis factor alpha (TNF-alpha) Interleukin-8 (IL-8) Interleukin-6 (IL-6) Interleukin-10 (IL-10) Interferon Gamma (IFNg) C5 |
|
|
skin cancer |
Official Title |
PD-L1/CD274 |
|
|
squamous cell cancer |
Official Title |
PD-L1/CD274 |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Vilobelimab - InflaRx | C-reactive protein (CRP) | Eligibility Criteria |
| C5 | Outcome Measure | |
| Interferon Gamma (IFNg) | Outcome Measure | |
| Interleukin-10 (IL-10) | Outcome Measure | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure | |
| Interleukin-8 (IL-8) | Outcome Measure | |
| PD-L1/CD274 | Official Title | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID-19 pneumonia | severe, critically ill, intubated, mechanically ventilated COVID-19 patients (EUA) | - | Registered | USA | IV / unspecified | InflaRx | 04 Apr 2023 |
| COVID-19 pneumonia | severe COVID-19 pneumonia | - | Preregistration | European Union | IV / unspecified | InflaRx | 30 Aug 2023 |
| COVID-19 pneumonia | severe COVID-19 pneumonia | - | Phase III | Brazil, Mexico, Peru, Russia, South Africa | IV / unspecified | InflaRx | 14 Sep 2020 |
| Granulomatosis with polyangiitis | - | In adults, In the elderly | Suspended (II) | Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom | IV / Infusion | InflaRx | 19 May 2022 |
| Granulomatosis with polyangiitis | add-on to standard of care | Adjunctive treatment | Suspended (II) | Canada, USA | IV / Infusion | InflaRx | 19 May 2022 |
| Hidradenitis suppurativa | - | - | Phase II | Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland | IV / Infusion | InflaRx | 26 Feb 2018 |
| Hidradenitis suppurativa | - | - | Suspended (III) | USA | IV / Infusion | InflaRx | 12 May 2022 |
| Hidradenitis suppurativa | - | - | No development reported (Preclinical) | Germany | SC / unspecified | InflaRx | 28 Jun 2023 |
| Inflammation | Viral inflammation | - | No development reported (I) | Germany | IV / Infusion | InflaRx | 28 Apr 2019 |
| Microscopic polyangiitis | add-on to standard of care | Adjunctive treatment | Suspended (II) | Canada, USA | IV / Infusion | InflaRx | 12 May 2022 |
| Microscopic polyangiitis | - | In adults, In the elderly | Suspended (II) | Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom | IV / Infusion | InflaRx | 12 May 2022 |
| Microscopic polyangiitis | - | - | Suspended (II) | USA | IV / Infusion | InflaRx | 12 May 2022 |
| Pyoderma gangrenosum | Ulcerative pyoderma gangrenosum | - | Phase III | Australia, Europe, USA (fast track) | IV / Infusion | InflaRx | 15 Aug 2023 |
| Pyoderma gangrenosum | - | - | Phase II | Canada | IV / Infusion | InflaRx | 16 May 2019 |
| Sepsis | - | Newly diagnosed | Discontinued (II) | Germany | IV / Infusion | InflaRx | 09 Jun 2021 |
| Squamous cell cancer | - | In adults, In the elderly, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater | Phase II | France, Germany, USA | IV / Infusion | InflaRx | 05 Jan 2021 |
| Squamous cell cancer | in combination with Pembrolizumab | Combination therapy, In adults, In the elderly, Late-stage disease, Metastatic disease, Second-line therapy or greater | Phase II | Belgium, France, Germany, Spain, USA | IV / Infusion | InflaRx | 01 Jun 2021 |
| Systemic inflammatory response syndrome | Systemic inflammatory response induced organ dysfunction in complex cardiac surgery | - | Discontinued (II) | Germany | IV / Infusion | InflaRx | 09 Jun 2021 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Pyoderma gangrenosum |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Pyoderma gangrenosum | - | Europe | InflaRx | 29 Jun 2022 |
| Pyoderma gangrenosum | - | USA | InflaRx | 29 Jun 2022 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| InflaRx | Originator | Germany |
| InflaRx | Owner | Germany |
| Staidson Beijing BioPharmaceuticals | Licensee | China |
| German Federal Ministry for Education and Research | Funder | Germany |
| Germany Federal Ministry of Health | Funder | Germany |
| Merck & Co | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| InflaRx | - | Unspecified | - | 18 May 2023 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Gohibic | InflaRx | COVID-19 pneumonia | USA |
Scientific Summary
Adverse Events
Updated results from the phase II/III PANAMO trial demonstrated that vilobelimab was safe. Serious AEs were 58.9% for vilobelimab and 63.5% for Plc.Treatment-emergent AEs were 90.9% vilobelimab vs 91.0% placebo (P). Infections were comparable: vilobelimab 62.9%, P 59.3%. Infection incidence per 100 Pt days were equal [22] No meningococcal infections were reported. Serious AEs were 58.9% vilobelimab, 63.5% P [21] . Previous results in a part II of a phase II/III trials, being conducted in patients with severely progressed pneumonia associated with COVID-2019 infections, vilobelimab treatment was well tolerated. There was one death in vilobelimab treatment arm after acute ventilator tube complication (leakage), the other death was due to pulmonary failure in patient with history of severe COPD. In the best supportive care group, there were four deaths due to COVID-2019 induced multi-organ failure. Three of these four were due to pulmonary embolisms as an SAE. Adverse events were comparatively lower in vilobelimab group [17] [14] .
In a phase IIa trial in patients with moderate to severe hidradenitis suppurativa, treatment with weekly intravenous vilobelimab was well tolerated, with no related adverse events, as well as no infusion-related, allergic or anaphylactic reactions [36] [38] .
Results from a phase IIa trial in patients with pyoderma gangraenosum demonstrated that, vilobelimab was well-tolerated and no new safety findings emerged. From all cohorts, two patients had related serious adverse events (SAEs) that were reported: One patient experienced an erysipelas leading to hospitalisation another developed a rash due to a delayed hypersensitivity reaction and withdrew from tral. No dose-related adverse events (AEs) were reported. The open-label trial intends to enrolled 19 patients [60] [58] [59] [61]
Results from a phase II IXPLORE trial demonstrated that vilobelimab was safe and well tolerated in combination with standard of care for patients with ANCA-associated vasculitis. The study compared two different doses of vilobelimab to placebo. All patients received current standard of care immunosuppressive therapy and high dose glucocorticoids (SOC). Patients were randomized into three groups: SOC plus placebo, SOC plus vilobelimab (400mg) and SOC plus vilobelimab (800mg), and were treated for 16 weeks (including a fractionated loading dose at days 4 and 8) followed by an observation period of 8 weeks. In all the groups, a similar number of patients experienced one or more treatment-emergent adverse events (TEAEs): 5 of 6 patients in SOC plus placebo group, 7 of 7 patients in SOC plus vilobelimab 400mg group, 6 of 6 patients in SOC plus vilobelimab 800mg group. In addition, a similar number of patients experienced TEAEs rated as drug-related by investigators: 3 of 6 patients (SOC plus placebo), 3 of 7 patients (SOC plus vilobelimab 400 mg), 2 of 6 patients (SOC plus vilobelimab 800 mg). Overall, there was no safety signal of concern detected in the study, as observed TEAEs are reflective of the disease and SOC treatment. At baseline, patients in the higher dose vilobelimab (800mg) group showed a higher Birmingham Vasculitis Activity Score (BVAS) of 17.5 mean / 16.5 median, when compared to the baseline BVAS scores of the SOC group (13.8 mean / 13.5 median) and the vilobelimab (400mg) group (13.1 mean / 12.0 median). The randomized, double-blind, placebo-controlled study enroled 19 patients in the US [40] [41] .
Results from phase II SCIENS trial for vilobelimab in patients with early or newly developing abdominal or pulmonary derived septic organ dysfunction showed that vilobelimab was well tolerated, with levels of adverse events or serious adverse events in treatment groups comparable to those in the control group. No relevant differences between placebo and treated patients were observed with respect to clinical laboratory parameters, ECGs or local tolerability. No anti-drug antibodies were detected during the 28 days of observation [3] [63] .
Results from phase II SCIENS trial for vilobelimab in patients undergoing pre-specified complex cardiac surgery showed that vilobelimab was well tolerated, and adverse events were comparable to control group. No relevant differences between placebo and treated patients were observed with respect to clinical laboratory parameters, ECGs or local tolerability [3] [65] .
In the phase II IXCHANGE trial of vilobelimab treatment in patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) diseases, vilobelimab-only group had the lowest number of reported treatment emergent AE (TEAE). In total, there were 14 serious TEAE (5, vilobelimab alone; 6, SDGC; and 3, vilobelimab + RDGC) [48] [46] .
Pharmacodynamics
Summary
Results from phase II SCIENS trial for vilobelimab in patients with early or newly developing abdominal or pulmonary derived septic organ dysfunction demonstrated that vilobelimab reduced elevated C5a levels in these patients with statistical significance in a dose dependent manner. Mean C5a concentrations were decreased in the different dose groups with high statistical significance (p < 0.01) starting at the first blood sampling two hours after the start of vilobelimab infusion. The duration of statistically significant decrease of C5a compared to placebo was 24 hours for the low dose group, 5 days for the medium dose group and 13 days for the high dose group (p < 0.01 at all time points except for the last time point at day 13 in the high dose group, p = 0.039) [3] [63] .
Results from phase II SCIENS trial for vilobelimab in patients undergoing pre-specified complex cardiac surgery showed that C5a plasma levels decreased significantly (p < 0.001) and in a dose-dependent manner. In all dose groups, MAC formation as assessed by the CH50 test was intact. High variability was noted in the patient population across the placebo and treatment arms, specifically for IL-6 levels. Vilobelimab did not affect IL-6 levels with statistical significance. Also, overall mortality was 1.9%, significantly below the levels in the published literature [3] [65] .
Therapeutic Trials
Treatment with vilobelimab resulted in a response rate of 75% (n=9/12) and 83% (n=10/12) at Week 8 (end of treatment) and at Week 20 (end of follow up), respectively, as assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score, in a phase IIa trial in patients with moderate to severe hidradenitis suppurativa. Positive trends of improvement were observed for other parameters, including the dermatology life-quality index. Retrospective long-term data revealed sustained remissions and median time to first flare of seven months, following eight weeks of treatment. Two flares occurred during the treatment period, and two flares occurred during the scheduled follow-up period. In the long-term follow-up, there were 26 flares, ranging from two to four per patient [85] [39] [36] [38] .
The final results from the phase IIa trial demonstrated that the during the follow-up period, ulcers remained closed two months after treatment completion in all but one patient, and a sustained suppression of C5a was observed for up to 20 days after the last dosing. The seventh patient showed a slight improvement (PGA score 4) with a decrease of the target ulcer area of over 50% [2] . Results from the cohort 3, at 2400mg biweekly dose of vilobelimab in the phase IIa trial in patients with pyoderma gangrenosum (n=7) evaluated for 26 weeks showed that six of the seven patients achieved clinical remission with a PGA score of =1, which reflects a closure of the target ulcer. All patients in cohort 3 had elevated C5a levels at baseline that were continuously suppressed after initiation of vilobelimab [61] . Earlier results showed that, out of the 10 patients evaluated for efficacy at day 99, four patients met the response criteria, with three of them achieved complete closure of the target ulcer closure increased from the 1600mg dose group to the highest dose of 2400mg dose on day 57 of the trial, and the ulcer closed after the dose escalation. At day 99, this patient had a PGA score of 1, and by the end of the treatment period at day 189 had a PGA score of 0. The three patients who showed clinical response with a PGA score of = 3 with complete target ulcer closure had elevated C5a levels at baseline. The other six patients showed slight improvement in their condition according to the PGA definition (PGA score = 4). Earlier results showed that, two of five patients treated with vilobelimab achieved complete closure of the target ulcer and complete healing of all other PG ulcers [60] [16] [59] .
Results from a phase II IXPLORE trial demonstrated no statistical significance on efficacy endpoints of vilobelimab in combination with standard of care for patients with ANCA-associated vasculitis. The study compared two different doses of vilobelimab to placebo. All patients received current standard of care immunosuppressive therapy and high dose glucocorticoids (SOC). Patients were randomized into three groups: SOC plus placebo, SOC plus vilobelimab (400mg) and SOC plus vilobelimab (800mg), and were treated for 16 weeks (including a fractionated loading dose at days 4 and 8) followed by an observation period of 8 weeks. The clinical response and remission for each treatment group was measured at week 16 as secondary efficacy endpoints using the Birmingham Vasculitis Score (BVAS). The proportion of patients achieving a clinical response was defined as a 50% reduction in BVAS at week 16 (and no worsening in any body system) compared to baseline, and clinical remission was defined as BVAS=0. The patients across all three treatment groups demonstrated a strong response at week 16, and more patients treated with SOC plus vilobelimab had clinical remissions at various timepoints throughout the study compared to SOC plus placebo. The randomized, double-blind, placebo-controlled study enroled 19 patients in the US [40] [41] .
In the phase II IXCHANGE trial of vilobelimab treatment in patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) diseases, clinical response and clinical remission rates were similar across the three arms at week 16 was 89% vs 96% vs 77% and 78% vs 87% vs 77%, respectively. The mean (SD) for GTI at week 16 was substantially lower with vilobelimab alone [0.8 (9.0)] when compared to the means for SDGC [44.9 (41.5)] and vilobelimab + RDGC [26.1 (39.2)]. There were no medically meaningful changes in eGFR in any arm [48] [46] .
Updated results from the phase II/III PANAMO trial showed that direct C5a inhibition by vilobelimab resulted in a survival benefit for critically ill COVID-19 Pt without increasing infections. Kaplan-Meier estimates showed a 28-Day mortality rate of 31.7% for Vilo vs 41.6% for Plc [HR 0.67 (95% CI: 0.48, 0.96), p< 0.05] with similar 60-Day results. On Day 8 after 3 infusions, mean vilobelimab trough levels were 21,799.3 to 302,972.1 ng/mL (geometric mean 137,881.3 ng/mL). C5a was highly elevated and comparable between groups at screening. By Day 8, C5a levels were reduced 87% for vilobelimab (mean 16.8 ng/mL, p< 0.001) vs an increase for Plc (mean 129.8 ng/mL). Though post Day 8 sampling was sparse, C5a levels remained elevated for Plc and low for vilobelimab throughout the study [22] Updated results from the phase II/III PANAMO trial demonstrated that vilobelimab significantly reduced mortality at 28 and 60 days in critically ill COVID-19 patients with no increase in infections suggesting the importance of targeting C5a while preserving MAC. The 28-d all-cause mortality was 31.7% with vilobelimab vs 41.6% with placebo (P) (Kaplan-Meier estimates; Cox regression site-stratified, HR 0.73; 95% CI:0.50-1.06; P = 0.094), representing a 23.8% relative mortality reduction. In predefined primary outcome analysis without site stratification, however, vilobelimab significantly reduced mortality at 28 (HR 0.67; 95% CI:0.48-0.96; P = 0.027) and 60 days (HR 0.67; 95% CI:0.48-0.92; P = 0.016). Vilobelimab also significantly reduced 28-d mortality in more severe patients with baseline WHO ordinal scale score of 7 (n = 237, HR 0.62; 95% CI:0.40-0.95; P = 0.028), severe ARDS/PaO2/FiO2 ≤ 100 mmHg (n = 98, HR 0.55; 95% CI:0.30-0.98; P = 0.044) and eGFR < 60 mL/min/1.73m2 (n = 108, HR 0.55; 95% CI:0.31-0.96; P = 0.036) [21] . Previous results from the phase II/III PANAMO trial demonstrated that the vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which was not statistically significant using site-stratified cox regression analysis as pre-specified in the final statistical analysis plan. The original protocol-specified analysis would have resulted in a statistically significant p-value of 0.027. Additionally, logistic regression analyses of 28-day all-cause mortality resulted in p-values of <0.05 for 3 out of the 4 pre-specified analyses. Importantly, 60-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm [2] . Efficacy data obtained from phase II/III trial indicated relative reduction in 28-day all cause mortality of 43% (vilobelimab 21.2% versus placebo 37.2%, p=0.014, hazard ratio: 0.5) in patients with severe acute respiratory distress syndrome (ARDS) and PaO2/FiO2 <100 (n=98, p=0.044); in intubated patients suffering from one or more additional organ support captured as baseline ordinal scale of 7 (n=237, p=0.028); and in patients with kidney impairment, captured by estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m² (n=108, p=0.036). As per site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan of the study, this was not statistically significant. The statistical analysis method was changed from non-stratified to site-stratified as per the recommendation of the regulatory authorities. In pre-specified subgroup analysis in Western European patients, a 43% of relative reduction in 28-day all cause mortality was detected, when vilobelimab was compared with placebo treatment (n=209, p-value=0.014). The analysis was done in intubated patients suffering from one or more additional organ support. Earlier data from the part II of a phase II/III trials indicated twenty-eight-day all-cause mortality in the vilobelimab treatment group was 13% (2 out of 15) versus 27% (4 out of 15) in the control group. In a vilobelimab treatment group, a higher number of patients with 2 or more comorbidities associated with increased COVID-19 mortality were reported, compared to best supportive care group. In the vilobelimab treatment group fewer patients experienced renal impairment assessed by estimated glomerular filtration rates and more patients showed reversal of blood lymphocytopenia and a greater lowering of lactate dehydrogenase concentrations as a sign of reduction in tissue damage. A temporary, but statistically significant increase of D-dimer levels in the first days following vilobelimab administration was reported, as a potential signal for induction of blood clot lysis. No statistically significant group differences on the relative percentage change from baseline to day five in oxygenation index (defined as PaO2/FiO2 ratio) were detected [18] [19] [17] [14] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Jun 2023 | Trial Update | InflaRx plans a phase III trial for Pyoderma gangrenosum in US, Europe and other countries in mid 2023 (9384676) | 31 Aug 2023 |
| 30 Sep 2022 | Regulatory Status | InflaRx plans to submit an Emergency Use Authorization (EUA) application the US FDA for the treatment of COVID-19 patients by the end of Q3 2022 (9363738) | 11 Oct 2022 |
| 31 Jul 2022 | Regulatory Status | InflaRx plans a Type B meeting with the US FDA to obtain guidance with respect to a potential emergency use authorization submission for COVID-19 pneumonia in early third quarter of 2022 [50] | 28 Jul 2022 |
| 30 Jun 2022 | Company Name Changes | InflaRx plans to meet with the US FDA for discussion regarding the design of a pivotal trial in Pyoderma Gangrenosum in mid of 2022 [2] | 08 Aug 2022 |
| 30 Sep 2021 | Trial Update | InflaRx announces intention to request a Type A meeting with the US FDA for phase III clinical development of vilobelimab in Hidradenitis suppurativa in third quarter of 2021 (9324097) [84] | 14 Sep 2021 |
| 30 Jun 2021 | Trial Update | InflaRx plans a phase IIa trial for Squamous-cell-cancer (Monotherapy, Combination therapy, Second-line therapy or greater, Metastatic disease) (IV) in first half of 2021 in Europe and USA (9291109) (700321340) (9313102) [30] | 19 May 2021 |
| 31 Mar 2021 | Company Name Changes | InflaRx plans to submit a Special Protocol Assessment (SPA) to the US FDA for the Phase III trial in Hidradenitis Suppurativa in the first quarter of 2021 (9313102) | 19 May 2021 |
| 30 Jun 2020 | Regulatory Status | InflaRx plans end of phase II meeting with US FDA to discuss future pivotal program in Hidradenitis Suppurativa in mid of 2020 [7] | 05 Aug 2020 |
| 31 Mar 2018 | Trial Update | InflaRx plans a phase IIb trial in Hidradenitis Suppurativa in USA and other countries (Trial profile 700288579) [35] | 12 Mar 2018 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 16 Apr 2024 | Trial Update | InflaRx plans a phase III trial for Adult respiratory distress syndrome (InflaRx Pipeline, April 2024) Updated 16 Apr 2024 |
| 11 Oct 2023 | Scientific Update | Updated efficacy and adverse events data from the phase II/III PANAMO trial in Pneumonia presented at the IDWeek 2023 (IDW-2023) [22] Updated 06 Feb 2024 |
| 31 Aug 2023 | Phase Change - Preregistration | Preregistration for COVID-19 pneumonia in European Union (IV) [10] Updated 01 Sep 2023 |
| 15 Aug 2023 | Phase Change - III | Phase-III clinical trials in Pyoderma gangrenosum in Australia (IV) (NCT05964413) [55] Updated 10 Nov 2023 |
| 15 Aug 2023 | Phase Change - III | Phase-III clinical trials in Pyoderma gangrenosum in Europe (IV) (NCT05964413) [55] Updated 10 Nov 2023 |
| 15 Aug 2023 | Phase Change - III | Phase-III clinical trials in Pyoderma gangrenosum in USA (IV) (NCT05964413) Updated 31 Aug 2023 |
| 28 Jun 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Hidradenitis suppurativa in Germany (SC) Updated 28 Jun 2023 |
| 21 Jun 2023 | Regulatory Status | InflaRx announces intention to submit MAA to EMA for COVID-19 pneumonia in Europe [9] Updated 23 Jun 2023 |
| 18 May 2023 | Licensing Status | Vilobelimab - InflaRx is available for licensing as of 18 May 2023. https://www.sec.gov/ix?doc=/Archives/edgar/data/1708688/000121390023021874/f20f2022_inflarxnv.htm Updated 18 May 2023 |
| 11 May 2023 | Regulatory Status | InflaRx announces intention to submit BLA to the US FDA for COVID-19 pneumonia [54] Updated 17 May 2023 |
| 11 May 2023 | Regulatory Status | InflaRx announces intention to submit MAA to the CHMP of EMA for COVID-19 pneumonia [54] Updated 17 May 2023 |
| 04 Apr 2023 | Phase Change - Registered | Registered for COVID-19 pneumonia in USA (IV) [8] Updated 23 May 2023 |
| 04 Apr 2023 | Regulatory Status | Vilobelimab receives Emergency Use Authorization for COVID-19-pneumonia in the US [8] Updated 11 Apr 2023 |
| 22 Mar 2023 | Trial Update | InflaRx plans a phase III trial for Pyoderma gangrenosum in US, Europe and other countries in mid 2023 [52] Updated 31 Aug 2023 |
| 05 Jan 2023 | Regulatory Status | Vilobelimab - InflaRx receives Fast Track designation for Pyoderma gangrenosum [IV,Infusion] in USA [53] Updated 07 Mar 2023 |
| 05 Jan 2023 | Trial Update | InflaRx plans a phase III trial for Pyoderma gangrenosum in US, Europe and other countries [53] Updated 09 Jan 2023 |
| 31 Dec 2022 | Patent Information | InflaRx has patent protection for vilobelimab in multiple countries worldwide [1] Updated 18 May 2023 |
| 31 Dec 2022 | Patent Information | InflaRx has patents pending for vilobelimab in multiple countries worldwide [1] Updated 18 May 2023 |
| 21 Dec 2022 | Company Involvement | InflaRx and Staidson (Beijing) BioPharmaceuticals enters into licensing agreement for the clinical, manufacturing and regulatory documentation regarding vilobelimab in China [6] Updated 26 Dec 2022 |
| 10 Nov 2022 | Scientific Update | Efficacy and adverse event data from the phase II IXCHANGE trial in Microscopic Polyangiitis and Granulomatosis with Polyangiitis presented at the American College of Rheumatology 2022 (ACR-2022) [48] Updated 05 Jan 2023 |
| 19 Oct 2022 | Scientific Update | Updated efficacy and safety data from the phase II/III PANAMO trial in Pneumonia presented at the IDWeek 2022 (IDW-2022) [21] Updated 02 Feb 2023 |
| 29 Sep 2022 | Phase Change - Preregistration | Preregistration for COVID-19 pneumonia in USA (IV) [11] Updated 04 Oct 2022 |
| 29 Sep 2022 | Regulatory Status | US FDA conditionally accepts 'Gohibic' as the proprietary name for vilobelimab as of September 2022 [11] Updated 04 Oct 2022 |
| 29 Sep 2022 | Regulatory Status | Vilobelimab receives Fast track status from the US FDA for COVID-19 pneumonia [IV] in USA [11] Updated 04 Oct 2022 |
| 05 Aug 2022 | Regulatory Status | InflaRx completes a end-of-phase II meeting with the US FDA regarding the design of a pivotal phase III trial in Pyoderma Gangrenosum, prior to August 2022 [56] Updated 10 Aug 2022 |
| 28 Jul 2022 | Regulatory Status | InflaRx plans to submit an Emergency Use Authorization (EUA) application the US FDA for the treatment of COVID-19 patients by the end of Q3 2022 [12] Updated 11 Oct 2022 |
| 26 Jul 2022 | Regulatory Status | InflaRx completes type B meeting with the US FDA [12] Updated 25 Oct 2022 |
| 06 Jul 2022 | Regulatory Status | Vilobelimab receives Fast track status from the US FDA for Pyoderma gangrenosum [49] Updated 08 Jul 2022 |
| 29 Jun 2022 | Regulatory Status | InflaRx plans a Type B meeting with the US FDA to obtain guidance with respect to a potential emergency use authorization submission for COVID-19 pneumonia in early third quarter of 2022 [50] Updated 28 Jul 2022 |
| 29 Jun 2022 | Regulatory Status | InflaRx plans regulatory filing for approval for Vilobelimab in COVID-19 pneumonia in EU [50] Updated 01 Jul 2022 |
| 29 Jun 2022 | Regulatory Status | InflaRx plans regulatory submission to obtain emergency use authorization for COVID-19 pneumonia in USA [50] Updated 01 Jul 2022 |
| 29 Jun 2022 | Regulatory Status | Vilobelimab - InflaRx receives Orphan Drug status for Pyoderma gangrenosum in Europe [50] Updated 01 Jul 2022 |
| 29 Jun 2022 | Regulatory Status | Vilobelimab - InflaRx receives Orphan Drug status for Pyoderma gangrenosum in USA [50] Updated 01 Jul 2022 |
| 28 Jun 2022 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Pyoderma-gangrenosum in Germany (IV, Infusion) Updated 28 Jun 2022 |
| 12 May 2022 | Company Involvement | InflaRx plans to meet with the US FDA for discussion regarding the design of a pivotal trial in Pyoderma Gangrenosum in mid of 2022 [2] Updated 08 Aug 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Granulomatosis with polyangiitis (Adjunctive treatment) in Canada, USA (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Granulomatosis with polyangiitis (In the elderly, In adults) in Belgium, United Kingdom, Denmark, Switzerland, Netherlands, Sweden, Italy, Germany, France (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Granulomatosis with polyangiitis (In the elderly, In adults) in Czech Republic, Spain (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Microscopic polyangiitis (Adjunctive treatment) in Canada, USA (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Microscopic polyangiitis (In the elderly, In adults) in Switzerland, Denmark, Germany, France, Czech Republic, Spain, Italy, Sweden, Netherlands, Belgium, Russia, United Kingdom (IV) [2] [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(II) | Suspended - Phase-II for Microscopic polyangiitis in USA (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Phase Change - Suspended(III) | Suspended - Phase-III for Hidradenitis suppurativa in USA (IV) [2] Updated 19 May 2022 |
| 12 May 2022 | Scientific Update | Efficacy data from a phase II/III PANAMO trial in Pneumonia released by InflaRx [2] Updated 19 May 2022 |
| 12 May 2022 | Scientific Update | Efficacy data from a phase IIa trial in Pyoderma gangraenosum released by InflaRx [2] Updated 19 May 2022 |
| 03 May 2022 | Trial Update | InflaRx terminates a phase II trial in Granulomatosis with Polyangiitis (GPA) and microscopic polyangiitis (MPA) in USA and Canada due to COVID-19 pandemic outbreak and its impact on overall study activities (NCT03712345) Updated 09 Jun 2022 |
| 31 Mar 2022 | Scientific Update | Efficacy data from a phase II/III PANAMO trial in Pneumonia released by InflaRx [19] Updated 01 Apr 2022 |
| 24 Mar 2022 | Trial Update | InflaRx plans a clinical trial in Pyoderma Gangrenosum [23] Updated 07 Apr 2022 |
| 17 Mar 2022 | Regulatory Status | US FDA granted a corrected advice letter to InflaRx related to its phase III program with vilobelimab for the treatment of Hidradenitis suppurativa [24] Updated 21 Mar 2022 |
| 03 Mar 2022 | Regulatory Status | InflaRx has received an advice letter from the US FDA related to its phase III program with vilobelimab for the treatment of Hidradenitis suppurativa [25] Updated 03 Mar 2022 |
| 05 Jan 2022 | Phase Change - III | Phase-III clinical trials in Hidradenitis suppurativa in USA (IV) [26] Updated 10 Jan 2022 |
| 03 Jan 2022 | Trial Update | InflaRx completes a phase IIa trial for Pyoderma gangrenosum in USA, Canada and Poland (IV, Infusion) (NCT03971643) Updated 18 Feb 2022 |
| 31 Dec 2021 | Trial Update | InflaRx completes a phase II/III trial in COVID-19-pneumonia in Russia, Peru, Mexico, France, Brazil, Belgium, Germany, India, Netherlands, South Africa and US (IV) (NCT04333420) Updated 22 Feb 2022 |
| 31 Dec 2021 | Regulatory Status | InflaRx intends to submit pivotal trial protocol to the US FDA in Q4 of 2021 (InflaRx pipeline, January 2022) Updated 04 Jan 2022 |
| 30 Nov 2021 | Regulatory Status | InflaRx submits protocol for phase III trial in Hidradenitis suppurativa to the US FDA in late November 2021 [26] Updated 10 Jan 2022 |
| 28 Oct 2021 | Scientific Update | Efficacy and safety data from a phase IIa trial in Pyoderma gangraenosum released by InflaRx [61] Updated 29 Oct 2021 |
| 12 Oct 2021 | Trial Update | InflaRx completes enrolment in the phase III PANAMO trial in COVID-19 pneumonia in Belgium, Brazil, France, Germany, Mexico, Netherlands, Peru, Russia and South Africa (IV) [15] Updated 14 Oct 2021 |
| 14 Sep 2021 | Trial Update | InflaRx plans a phase III trial for Hidradenitis suppurativa [27] Updated 14 Sep 2021 |
| 09 Sep 2021 | Regulatory Status | InflaRx completed type A meeting with US FDA for phase III Hidradenitis suppurativa study design [27] Updated 14 Sep 2021 |
| 26 Aug 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 10 Aug 2021 | Scientific Update | Efficacy and adverse events data from a phase IIa trial in Pyoderma gangraenosum released by InflaRx [60] Updated 17 Aug 2021 |
| 10 Aug 2021 | Trial Update | InflaRx completes enrolment in its phase IIa trial for Pyoderma gangraenosum in the US, Canada and Poland, prior to August 2021 [60] Updated 17 Aug 2021 |
| 05 Aug 2021 | Trial Update | InflaRx announces intention to request a Type A meeting with the US FDA for phase III clinical development of vilobelimab in Hidradenitis suppurativa in third quarter of 2021 [20] [84] Updated 14 Sep 2021 |
| 09 Jun 2021 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Sepsis (Newly diagnosed) in Germany (IV) [3] Updated 15 Jun 2021 |
| 09 Jun 2021 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Systemic inflammatory response syndrome in Germany (IV) [3] Updated 15 Jun 2021 |
| 09 Jun 2021 | Regulatory Status | InflaRx plans to apply for Orphan Drug status in ANCA-associated vasculitis in USA and in Europe [3] Updated 15 Jun 2021 |
| 09 Jun 2021 | Scientific Update | Final adverse events and pharmacodynamics data from phase II CARDIAC trial in Systemic inflammatory response syndrome released by InflaRx [3] Updated 15 Jun 2021 |
| 09 Jun 2021 | Scientific Update | Final adverse events and pharmacodynamics data from phase II SCIENS trial in Sepsis released by InflaRx [3] Updated 15 Jun 2021 |
| 08 Jun 2021 | Trial Update | InflaRx completes the phase II IXCHANGE trial in Microscopic Polyangiitis and Granulomatosis with Polyangiitis (In the elderly) in Czech Republic, France, Germany, Russia, Italy, Sweden, the Netherlands, Spain, the UK, Switzerland, Sweden, Denmark and Belgium (IV) in June 2021 (EudraCT2018-000768-27; NCT03895801) Updated 17 Aug 2021 |
| 01 Jun 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Combination therapy, In the elderly, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults) in Spain, Belgium (IV), after June 2021 (NCT04812535) Updated 24 Mar 2023 |
| 12 May 2021 | Scientific Update | Final efficacy and safety data from a phase II IXPLORE trial in ANCA-associated Vasculitis released by InflaRx [40] Updated 17 May 2021 |
| 03 May 2021 | Trial Update | InflaRx completes the phase II IXPLORE trial in Microscopic polyangiitis in US and Canada (IV) (NCT03712345) Updated 06 Sep 2021 |
| 15 Apr 2021 | Scientific Update | Interim adverse events data from a phase IIa trial in Pyoderma gangrenosum released by InflaRx [58] Updated 19 Apr 2021 |
| 15 Apr 2021 | Trial Update | InflaRx completes enrolment in its phase IIa trial for Pyoderma gangrenosum in USA, Canada and Poland (NCT03971643) [58] Updated 19 Apr 2021 |
| 25 Mar 2021 | Regulatory Status | InflaRx submits a Special Protocol Assessment (SPA) to the US FDA for the phase III trial in Hidradenitis Suppurativa before March 2021 [28] Updated 30 Mar 2021 |
| 11 Jan 2021 | Company Involvement | InflaRx plans to submit a Special Protocol Assessment (SPA) to the US FDA for the Phase III trial in Hidradenitis Suppurativa in the first quarter of 2021 Updated 19 May 2021 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Late-stage disease, In the elderly, Combination therapy, Second-line therapy or greater, In adults, Metastatic disease) in USA (IV) [68] (NCT04812535, EudraCT2020-000864-42) Updated 18 Feb 2022 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Metastatic disease, Monotherapy, In adults, Second-line therapy or greater, In the elderly, Late-stage disease) in USA (IV) [68] (NCT04812535, EudraCT2020-000864-42) Updated 18 Feb 2022 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (In adults, In the elderly, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in Germany (IV) (EudraCT2020-000864-42) Updated 14 Jun 2021 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Combination therapy, In the elderly, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults) in Germany (IV) (EudraCT2020-000864-42) Updated 06 Apr 2021 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults, In the elderly) in France (IV) (EudraCT2020-000864-42) Updated 12 Jan 2021 |
| 05 Jan 2021 | Phase Change - II | Phase-II clinical trials in Squamous cell cancer (In adults, In the elderly, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in France (IV) (EudraCT2020-000864-42) Updated 12 Jan 2021 |
| 05 Jan 2021 | Trial Update | InflaRx completes enrolment in its phase II IXchange trial for Granulomatosis with Polyangiitis and Microscopic Polyangiitis in Czech Republic, France, Germany, Russia, Italy, Sweden, the Netherlands, Spain, the UK, Switzerland, Sweden, Denmark and Belgium [47] Updated 07 Jan 2021 |
| 02 Dec 2020 | Phase Change - II | Phase-II clinical trials in Granulomatosis with polyangiitis (In adults, In the elderly) in Denmark, Switzerland (IV) before December 2020 (NCT03895801) Updated 09 Dec 2020 |
| 02 Dec 2020 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (In adults, In the elderly) in Denmark, Switzerland (IV) before December 2020 (NCT03895801) Updated 09 Dec 2020 |
| 17 Sep 2020 | Patent Information | InflaRx has pending US non-provisional patent application and one worldwide patent application under the PCT covering inhibitors of C5aR Updated 15 Jun 2021 |
| 14 Sep 2020 | Phase Change - III | Phase-III clinical trials in COVID-19 pneumonia in Russia, Peru, Mexico, France, Brazil, Belgium, Germany, Netherlands (IV) [13] (NCT04333420) (EudraCT2020-001335-28) Updated 19 May 2021 |
| 14 Sep 2020 | Phase Change - III | Phase-III clinical trials in COVID-19 pneumonia in Netherlands (IV) [13] Updated 16 Sep 2020 |
| 14 Sep 2020 | Regulatory Status | The Paul-Ehrlich-Institut grants approval for a phase III trial in COVID-19 pneumonia in Germany [13] Updated 16 Sep 2020 |
| 30 Jul 2020 | Trial Update | InflaRx plans a phase IIa trial for Squamous-cell-cancer (Monotherapy, Combination therapy, Second-line therapy or greater, Metastatic disease) (IV) in first half of 2021 in Europe and USA [7] [30] Updated 19 May 2021 |
| 30 Jul 2020 | Regulatory Status | InflaRx intends to submit biologic license application with the US FDA for Hidradenitis suppurativa [30] Updated 05 Aug 2020 |
| 30 Jul 2020 | Trial Update | InflaRx plans a phase III trial in Hidradenitis suppurativa in USA and Europe [30] Updated 05 Aug 2020 |
| 21 Jul 2020 | Scientific Update | Interim efficacy data from the phase II part of the phase II/III PANAMO trial in Pneumonia released by InflaRx [19] Updated 22 Jul 2020 |
| 17 Jun 2020 | Scientific Update | Interim adverse events and efficacy data from a the phase II/III PANAMO trial in Pneumonia released by InflaRx [17] Updated 18 Jun 2020 |
| 21 May 2020 | Scientific Update | Efficacy data from a phase IIa trial in Pyoderma gangrenosum released by InflaRx [16] Updated 28 May 2020 |
| 16 May 2020 | Trial Update | InflaRx reinitiates the phase II IXPLORE trial for Microscopic polyangiitis in US and Canada (IV)(NCT03712345) [29] Updated 02 Nov 2020 |
| 29 Apr 2020 | Regulatory Status | InflaRx plans end of phase II meeting with US FDA to discuss future pivotal program in Hidradenitis Suppurativa in mid of 2020 [7] Updated 05 Aug 2020 |
| 29 Apr 2020 | Trial Update | InflaRx plans a phase IIa trial for undisclosed tumour (Combination therapy) (IV) [7] Updated 05 May 2020 |
| 29 Apr 2020 | Trial Update | InflaRx suspends enrolment in the phase II IXPLORE trial for Microscopic polyangiitis in US and Canada (IV) based on blinded interim analysis and impact of COVID-19 pandemic (NCT03712345) Updated 05 May 2020 |
| 28 Apr 2020 | Licensing Status | InflaRx and Merck enters clinical collaboration to conduct clinical trial of vilobelimab in combination with pembrolizumab [7] Updated 05 May 2020 |
| 28 Apr 2020 | Trial Update | InflaRx plans a phase I trial for Cancer before November 2018 (InflaRx pipeline, April 2020) Updated 28 Apr 2020 |
| 06 Apr 2020 | Regulatory Status | InflaRx receives regulatory approval to start clinical trials for vilobelimab in COVID-19 pneumonia in Netherlands [5] Updated 06 Apr 2020 |
| 31 Mar 2020 | Phase Change - III | Phase-III clinical trials in COVID-19 pneumonia in South Africa (IV) after March 2020 (NCT04333420) Updated 14 Oct 2021 |
| 31 Mar 2020 | Phase Change - III | Phase-III clinical trials in COVID-19 pneumonia in Russia, Peru, Mexico, France, Brazil, Belgium (IV) after March 2020 (NCT04333420) (EudraCT2020-001335-28) Updated 19 May 2021 |
| 31 Mar 2020 | Phase Change - III | Phase-III clinical trials in COVID-19 pneumonia in Germany (IV) after March 2020 (EudraCT2020-001335-28) Updated 18 Sep 2020 |
| 31 Mar 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-19 pneumonia in Netherlands (Parenteral) (NCT04333420) [5] (EudraCT2020-001335-28) Updated 06 Apr 2020 |
| 17 Mar 2020 | Trial Update | InflaRx completes the phase II SHINE trial for Hidradenitis suppurativa in USA, Greece, Bulgaria, Canada, Denmark, France, Germany, Netherlands and Poland (NCT03487276) Updated 17 Mar 2020 |
| 23 Aug 2019 | Phase Change - II | Phase-II clinical trials in Granulomatosis with polyangiitis (Adjunctive treatment) in Canada (IV) (NCT03712345) Updated 07 Feb 2020 |
| 23 Aug 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (Adjunctive treatment) in Canada (IV) (NCT03712345) Updated 07 Feb 2020 |
| 14 Aug 2019 | Regulatory Status | InflaRx intends to discuss the data regarding SHINE trial with the regulatory authorities in an end of phase II meeting [42] Updated 20 Aug 2019 |
| 13 Aug 2019 | Patent Information | InflaRx has worldwide patent protection for anti- C5a antibodies for diseases that involve acute or chronic inflammation Updated 15 Jun 2021 |
| 13 Jun 2019 | Trial Update | InflaRx initiates enrolment in a phase IIa for Pyoderma gangraenosum in Canada (IV) (NCT03971643) Updated 17 Jun 2019 |
| 07 Jun 2019 | Active Status Review | Phase-I development is ongoing for Inflammation in Germany (IV) (InflaRx pipeline, June 2019) Updated 07 Jun 2019 |
| 23 May 2019 | Phase Change - I | Phase-I clinical trials in Pyoderma gangrenosum in Germany (IV) (InflaRx pipeline, May 2019) Updated 07 Jun 2019 |
| 23 May 2019 | Phase Change - Preclinical | Preclinical trials in Hidradenitis suppurativa in Germany (SC) before May 2019 [39] Updated 07 Jun 2019 |
| 23 May 2019 | Regulatory Status | Health Canada approves clinical trial application for a prospective phase IIa trial in Pyoderma gangraenosum (IV) [39] Updated 07 Jun 2019 |
| 23 May 2019 | Trial Update | InflaRx plans a phase IIa trial in Pyoderma Gangraenosum in Canada (IV) [39] Updated 07 Jun 2019 |
| 16 May 2019 | Phase Change - II | Phase-II clinical trials in Pyoderma gangrenosum in USA (IV) and Poland (IV) (NCT03971643) Updated 23 Apr 2021 |
| 01 May 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis in USA (IV) [39] Updated 07 Jun 2019 |
| 01 May 2019 | Phase Change - II | Phase-II clinical trials in Pyoderma gangrenosum in Canada (IV) (NCT03971643) Updated 07 Jun 2019 |
| 28 Apr 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Inflammation in Germany (IV, Infusion) Updated 28 Apr 2019 |
| 22 Mar 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (In adults, In the elderly) in Russia (IV) (NCT03895801) Updated 07 Jun 2019 |
| 22 Mar 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (In the elderly, In adults) in United Kingdom (IV) (NCT03895801) Updated 07 Jun 2019 |
| 22 Mar 2019 | Phase Change - II | Phase-II clinical trials in Wegener's granulomatosis (In the elderly, In adults) in United Kingdom (IV) (NCT03895801) Updated 07 Jun 2019 |
| 22 Mar 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (In the elderly, In adults) in Belgium, Netherlands, Sweden, Italy, Germany, France, Czech Republic (IV) (NCT03895801) Updated 21 May 2019 |
| 17 Jan 2019 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (In adults, In the elderly) in Spain (IV) (EudraCT2018-000768-27) Updated 30 Jan 2019 |
| 17 Jan 2019 | Phase Change - II | Phase-II clinical trials in Wegener's granulomatosis (In adults, In the elderly) in Spain (IV) (EudraCT2018-000768-27) Updated 30 Jan 2019 |
| 19 Dec 2018 | Regulatory Status | The European regulatory authorities approves the Investigational Medicinal Product Dossier to initiate phase-II trial in Microscopic polyangiitis [44] Updated 07 Jun 2019 |
| 30 Nov 2018 | Phase Change - Preclinical | Preclinical trials in Cancer in Germany (IV) (InflaRx pipeline, April 2020) Updated 28 Apr 2020 |
| 21 Nov 2018 | Trial Update | InflaRx completes enrolment in its phase II trial for Hidradenitis suppurativa in USA, Greece, Bulgaria, Canada, Denmark, France, Germany, Netherlands and Poland [37] (NCT03487276) Updated 07 Jun 2019 |
| 15 Oct 2018 | Phase Change - II | Phase-II clinical trials in Granulomatosis with polyangiitis(Adjunctive treatment) in USA (IV) (NCT03712345) Updated 25 Oct 2018 |
| 15 Oct 2018 | Phase Change - II | Phase-II clinical trials in Microscopic polyangiitis (Adjunctive treatment) in USA (IV) (NCT03712345) Updated 25 Oct 2018 |
| 28 Jun 2018 | Regulatory Status | The US FDA approves IND application for vilobelimab in ANCA-associated vasculitis (AAV) [43] Updated 23 Jul 2018 |
| 03 May 2018 | Trial Update | InflaRx plans a phase II trials in AAV patients, neutrophil-driven autoimmune and inflammatory disorders Updated 14 May 2018 |
| 16 Mar 2018 | Trial Update | InflaRx initiates enrolment in the phase II SHINE trial for Hidradenitis suppurativa in Greece (EudraCT2017-004501-40) Updated 09 Apr 2018 |
| 26 Feb 2018 | Phase Change - II | Phase-II clinical trials in Hidradenitis suppurativa in Bulgaria, Canada, Denmark, France, Germany, Netherlands, Poland (IV) after February 2018 (NCT03487276) Updated 07 Jun 2019 |
| 26 Feb 2018 | Phase Change - II | Phase-II clinical trials in Hidradenitis suppurativa in USA (IV) [34] (NCT03487276) Updated 12 Mar 2018 |
| 09 Jan 2018 | Trial Update | InflaRx plans a phase IIb trial in Hidradenitis Suppurativa in USA and other countries (Trial profile 700288579) [35] Updated 12 Mar 2018 |
| 09 Jan 2018 | Regulatory Status | The US FDA approves IND application for vilobelimab in Hidradenitis Suppurativa [35] Updated 16 Jan 2018 |
| 07 Sep 2017 | Scientific Update | Top-line adverse events and efficacy data from a phase IIa trial in Hidradenitis suppurativa released by InflaRx [36] Updated 11 Sep 2017 |
| 07 Sep 2017 | Trial Update | InflaRx plans a phase IIb trial in Hidradenitis suppurativa [36] Updated 11 Sep 2017 |
| 01 Jul 2017 | Trial Update | InflaRx completes a phase II trial in Hidradenitis suppurativa in Greece (IV) (NCT03001622) Updated 26 Sep 2017 |
| 01 Jan 2017 | Trial Update | InflaRx completes a phase II trial in Systemic inflammatory response syndrome in Germany (NCT02866825) Updated 24 Feb 2017 |
| 04 Nov 2016 | Phase Change - II | Phase-II clinical trials in Hidradenitis suppurativa in Greece (IV) (EudraCT2016-002988-33) Updated 22 Nov 2016 |
| 03 Mar 2016 | Phase Change - I | Phase-I clinical trials in Inflammation in Germany (IV) before March 2016 Updated 04 Mar 2016 |
| 03 Mar 2016 | Phase Change - II | Phase-II clinical trials in Systemic inflammatory response syndrome in Germany (IV) (InflaRx pipeline, March 2016; NCT02866825) Updated 04 Mar 2016 |
| 01 Jan 2016 | Trial Update | InflaRx completes a phase II trial in Sepsis (newly diagnosed) in Germany (Intravenous) [62] Updated 27 Jul 2016 |
| 24 Sep 2015 | Patent Information | InflaRx has worldwide patent protection for anti- C5a antibodies for the treatment of viral pneumonia Updated 15 Jun 2021 |
| 15 Feb 2015 | Phase Change - Preclinical | Preclinical trials in Systemic inflammatory response syndrome in Germany (unspecified route) Updated 04 Mar 2016 |
| 23 Dec 2013 | Phase Change - II | Phase-II clinical trials in Sepsis (newly diagnosed) in Germany (Intravenous) Updated 04 Apr 2014 |
| 18 Jan 2012 | Trial Update | InflaRx completes a phase I trial in healthy volunteers in Germany [66] Updated 19 Jan 2012 |
| 03 Jun 2011 | Patent Information | InflaRx has worldwide patent protection for anti- C5a antibodies for the treatment and prevention of various acute and chronic diseases, in particular acute inflammatory diseases Updated 15 Jun 2021 |
| 28 Mar 2011 | Phase Change - I | Phase-I clinical trials in Sepsis in Germany (IV) Updated 08 Apr 2011 |
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InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum.
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InflaRx Provides Development Update for Vilobelimab in Pyoderma Gangrenosum and Severe COVID-19.
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A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum
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InflaRx Reports Full Year 2022 Financial and Operating Results.
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InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients.
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InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update.
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InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum.
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InflaRx Reports Second Quarter 2022 Financial & Operating Results.
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InflaRx Treats First Patient in Phase IIa Clinical Trial with Lead Candidate IFX-1 in Pyoderma Gangraenosum.
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InflaRx Completes Enrollment of Vilobelimab Phase IIa Study in Pyoderma Gangraenosum.
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Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)
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InflaRx Announces Positive Data from Second Interim Analysis of Ongoing Phase IIa Open Label Study with Vilobelimab in Pyoderma Gangraenosum.
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InflaRx Announces Positive Data from Third Cohort of Phase IIa Open-Label Study with Vilobelimab in Pyoderma Gangraenosum.
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DGAP-News: InflaRx GmbH / Key word(s): Financing InflaRx raises EUR 31 million (US$ 34M) in a Series C financing round to foster complement inhibitor development.
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A phase II randomized, placebo-controlled, double-blind, dose controlled trial in patients suffering from early, newly developing abdominal or pulmonary derived septic organ dysfunction to evaluate safety, pharmacokinetics, pharmacodynamics and to estimate efficacy of the new humanized monoclonal i.v. administered antibody CaCP29
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InflaRx announces positive phase IIa top-line results from the SCIENS trial investigating IFX-1, a first-in-class anti-complement C5a antibody.
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A Phase II Randomized, Placebo-controlled, Double-blind, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamic Dose Response Relationship of IFX-1 in Patients Undergoing Complex Cardiac Surgery
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InflaRx Announces Successful Conduct of Its Clinical Phase I Trial with IFX-1, a New Monoclonal Antibody Inhibiting Complement Driven Inflammation.
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A Single Ascending, Placebo-controlled, Double-blind Study in Healthy Male Subjects to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the New Humanized Monoclonal Antibody CaCP29
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InflaRx Reports Progress in Ongoing Phase II Clinical Trial with Vilobelimab in Cutaneous Squamous Cell Carcinoma.
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OPEN LABEL, MULTICENTER PHASE II STUDY OF THE C5A-ANTIBODY IFX-1 ALONE OR IFX-1 + PEMBROLIZUMAB IN PATIENTS WITH PD-1- OR PD-L1-RESISTANT/REFRACTORY LOCALLY ADVANCED OR METASTATIC CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)
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InflaRx Doses First Patient in Multicenter Phase II Clinical Trial in Cutaneous Squamous Cell Carcinoma with Vilobelimab.
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Treatment with anti-C5a antibody improves the outcome of H7N9 virus infection in African green monkeys. Internet-Doc 2016;.
Available from: URL: http://www.ncbi.nlm.nih.gov/pubmed/25433014 -
InflaRx Announces Pricing of $40 Million Public Offering of Ordinary Shares.
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InflaRx Announces Closing of $75 Million Public Offering of Common Shares and One-Year Warrants.
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InflaRx Announces Pricing of $75 Million Public Offering of Common Shares and One-Year Warrants.
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InflaRx Announces Proposed Offering of Common Shares and One-Year Warrants.
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InflaRx Full Year 2018 Financial & Operating Results.
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InflaRx N.V. Announces Proposed Primary and Secondary Offerings of Common Shares.
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InflaRx Closes Funding to Move Its Complement Antibody Program into Clinical Trials for Sepsis Treatment.
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InflaRx Raises Financing to Develop a New Therapeutic Approach against Sepsis.
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Treatment of inflammatory diseases with inhibitors of c5a activity_Patent. Internet-Doc 2021;.
Available from: URL: https://patents.google.com/patent/US20210046191A1/en?assignee=InflaRx&oq=+InflaRx -
Anti-c5a binding moieties with high blocking activity_Patent. Internet-Doc 2021;.
Available from: URL: https://patents.google.com/patent/WO2011063980A1/en?assignee=InflaRx&oq=+InflaRx -
Patent for Fused piperidinyl bicyclic and related compounds as modulators of c5a receptor. Internet-Doc 2021;.
Available from: URL: https://patents.google.com/patent/US20200290969A1/en?assignee=InflaRx&oq=+InflaRx -
InflaRx Reports Second Quarter 2021 Financial & Operating Results.
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InflaRx Announces Presentation of New Clinical Data with Lead Candidate IFX-1 in Hidradenitis Suppurativa.
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