In March 2020, InflaRx initiated the phase II/III PANAMO trial to assess the efficacy of IFX 1 in patients with severe COVID-19 pneumonia (NCT04333420; IFX-1-P2.9). The randomized trial will enroll approximately 130 patients in Netherlands. The relative percentage change from baseline to day 5 in the oxygenation index (PaO2 / FiO2) is defined primary end point of the trial  . In April 2020, InflaRx dosed the first patient with IFX 1 with severe COVID-19 pneumonia in the Netherlands. Also in April 2020, enrolment of 30 patients in Part 1 was completed. Based on the company´s existing pre-clinical research on the role of C5a in viral-induced pneumonia and the initial results from the BDB 1 [see separate profile800058053] study, InflaRx initiated a clinical development program with IFX-1 in COVID-19 patients with severely progressed pneumonia. The company has received regulatory approval to start the trial in the Netherlands. Subject to regulatory approval, the company plans to initiate additional centers in Germany and potentially other European countries   .
Hidradenitis suppurativa (HS)
InflaRx in July 2019, reported that the trial did not meet the primary endpoint of a dose dependent drug effect on Hidradenitis Suppurativa Clinical Response Score (HiSCR)  . In January 2020, InflaRx, in collaboration with Quintiles, completed the phase IIb SHINE trial designed to evaluate the dose-response signal of IFX 1 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, Netherlands, Greece, Germany and Poland  . 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 IFX 1 as well as an assessment of additional efficacy and patient-reported outcome parameters  . 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  . Earlier, in January 2018, the US FDA accepted IND application filed for the trial   . In November 2018, company reported that enrolment in the trial was completed  .
In July 2017, InflaRx completed a phase IIa trial that evaluated the safety and efficacy of intravenous IFX 1, 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   .
In May 2019, InflaRx reported that preclinical development was underway, for a subcutaneous formulation of IFX 1, for the treatment of hidradenitis suppurativa. The company intends to potentially explore this formulation in other indications  .
IFX 1 is in phase I development for viral inflammation (InflaRx pipeline, June 2019).
Microscopic Polyangiitis (ANCA-associated vasculitis)
In April 2020, InflaRx suspended phase II IXPLORE trial for the microscopic polyangiitis based on a blinded interim analysis and potential impact of the COVID-19 pandemic (NCT03712345; IFX-1-P2.6)  . The trial was initiated in October 2018 and intends to recruit 36 patients in US and Canada  . Earlier in June 2018, IND application for the trial was approved by US FDA. In November 2018, company reported that the first patient was dosed     .
In March 2019, InflaRx initiated the phase II IXchange trial to evaluate the efficacy of IFX 1 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 is enrolling approximately 80 patients in Czech Republic, France, Germany, Russia, Italy, Sweden, the Netherlands, Spain, the UK and Belgium. The study will be conducted in two parts. In Part 1, patients were randomised to receive either IFX 1 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 IFX 1 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). In May 2020, the company completed enrolment in the Part 1 and also an independent Data Monitoring Committee completed analysis of available data from the part. Based on the analysis, the company intends to continue with Part 2 of the study but decrease the number of enrolled patients. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16. In June 2019, the first patient was enrolled in the trial. In August 2019, the first patient was treated in the study  . 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    . In August 2019, results form the trial were released by the company. The results In a phase II IXchange trial, high-dose treatment with IFX 1 resulted in 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   .
In October 2018, InflaRx initiated and dosed the first patient in a phase II trial to evaluate the safety and tolerability of two dose regimens of IFX 1 as add-on to standard of care (SOC) in patients with microscopic polyangiitis (IFX-1-P2.6; NCT03712345). The randomised, double-blind, placebo-controlled trials intends to enrol approximately 36 patients in the US and Canada. Earlier, in June 2018, the US FDA approved an IND application for the trial. Primary endpoint is the number of patients who experience at least one treatment emergent adverse event per treatment group    .
In May 2019, InflaRx initiated a phase IIa trial to evaluate the safety and efficacy of IFX 1 in patients with pyoderma gangrenosum. The trial intends to enrol approximately 12 patients in Canada. Earlier, The Health Canada had approved the initiation of the trial. In June 2019, the first patient was treated in the study    . Out of these 5 initial patients dosed with IFX-1, 2 patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. The drug was well tolerated and no drug-related severe adverse events  .
As at May 2019, IFX 1 was undergoing phase I development in this indication (InflaRx pipeline, May 2019).
The primary endpoints were met in the phase II SCIENS trial completed in January 2016, that evaluated the safety, pharmacokinetics and pharmacodynamics of IFX 1 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   . Positive data were reported in January 2016. IFX 1 dose-dependently and significantly reduced and suppressed inflammatory complement pathwayC5a  .
Systemic inflammatory response syndrome
In January 2017, InflaRx completed the phase II CARDIAC trial which evaluated whether the prophylactic treatment with IFX 1 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)  .
InflaRx has completed a phase I clinical trial with IFX 1. The trial reached its endpoints, showing that the drug was safe and well-tolerated with desirable pharmacodynamic and pharmacokinetic parameters  . InflaRx initiated the phase I trial in March 2011 (NCT01319903). The trial enrolled 26 subjects in Germany  .
In October 2018, InflaRx initiated and dosed the first patient in a phase II trial to evaluate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in patients with granulomatosis with polyangiitis (as Wegener's granulomatosis in development table) (IFX-1-P2.6; NCT03712345). The randomised, double-blind, placebo-controlled trials intends to enrol approximately 36 patients in the US   .
In African green monkeys, IFX 1 reduced acute lung injury and systemic inflammatory response syndrome, induced by H7N9 virus infections  .
In June 2019, InflaRx announced that it has raised $62.9 million in a follow-on offering to advance clinical programs for IFX-1  .
InflaRx, in June 2019, announced 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 IFX 1 in HS patients, a phase II clinical development program for IFX 1 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  .
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 IFX 1 and the preclinical development of the follow-up pipeline-molecules  .
InflaRx has completed three milestone-driven tranches of series A financing   .