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IFX 1

Drug Profile

IFX 1

Alternative Names: CaCP 29; IFX-1

Latest Information Update: 28 May 2020

At a glance

  • Originator Beijing Mabworks Biotech; InflaRx
  • Developer InflaRx
  • Class Anti-infectives; Anti-inflammatories; Antivirals; Monoclonal antibodies; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Complement C5a inhibitors; Inflammation mediator modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III COVID 2019 infections
  • Phase II Granulomatosis with polyangiitis; Hidradenitis suppurativa; Microscopic polyangiitis; Pyoderma gangrenosum; Sepsis; Systemic inflammatory response syndrome
  • Preclinical Cancer
  • No development reported Inflammation

Most Recent Events

  • 21 May 2020 Efficacy data from a phase IIa trial in Pyoderma gangrenosum released by InflaRx
  • 29 Apr 2020 InflaRx plans a phase IIa trial for undisclosed tumour (Combination therapy) (IV)
  • 29 Apr 2020 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)

Development Overview

Introduction

IFX 1 (CaCP 29), is an intravenous first-in-class, anti-complement C5a monoclonal antibody, that is being developed by InflaRx, in collaboration with Beijing Mabworks Biotech, for the treatment of inflammation, in particular sepsis. It is also being developed for the potential treatment of cancer. IFX 1 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 [see AdisInsight drug profile 800029865]. IFX 1 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. Clinical development is underway for hidradenitis suppurativa, pyoderma gangraenosum, viral inflammation, sepsis, systemic inflammatory response syndrome, microscopic polyangiitis and Wegener's granulomatosis in several countries. Clinical development for COVID-2019 infections is underway in Netherlands. Preclinical development for cancer is underway in Germany. InflaRx is also developing a subcutaneous formulation for IFX 1, for which preclinical development in hidradenitis suppurativa is underway in Germany.

Phase-I development was underway in Inflammation in Germany (IV, Infusion), but no development has been reported.

Company Agreements

As of April 2020, InflaRx and Merck enters into clinical collaboration agreement to evaluate combination of 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 IFX-1 arms, including one with pembrolizumab. [1]

Key Development Milestones

COVID-2019 infections

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 [2] . 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 [3] [4] .

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) [5] . 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 [6] . 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 [7] . 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 [1] . Earlier, in January 2018, the US FDA accepted IND application filed for the trial [8] [9] . In November 2018, company reported that enrolment in the trial was completed [10] .

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 [9] [11] .

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 [12] .

Inflammation

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) [1] . The trial was initiated in October 2018 and intends to recruit 36 patients in US and Canada [13] . 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 [14] [10] [12] [15] .

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 [14] . 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 [16] [17] [18] . 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 [3] [14] .

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 [19] [20] [13] .

Pyoderma Gangraenosum

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 [21] [12] [22] . 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 [1] .

As at May 2019, IFX 1 was undergoing phase I development in this indication (InflaRx pipeline, May 2019).

Sepsis

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 [23] [24] . Positive data were reported in January 2016. IFX 1 dose-dependently and significantly reduced and suppressed inflammatory complement pathwayC5a [25] .

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) [26] .

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 [27] . InflaRx initiated the phase I trial in March 2011 (NCT01319903). The trial enrolled 26 subjects in Germany [28] .

Wegener's granulomatosis

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 [20] [13] .

In African green monkeys, IFX 1 reduced acute lung injury and systemic inflammatory response syndrome, induced by H7N9 virus infections [29] .

Financing information

In June 2019, InflaRx announced that it has raised $62.9 million in a follow-on offering to advance clinical programs for IFX-1 [30] .

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 [31] .

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 [23] .

InflaRx has completed three milestone-driven tranches of series A financing [32] [33] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, Parenteral, SC
  • Formulation Infusion, unspecified
  • Class Anti-infectives, Anti-inflammatories, Antivirals, Monoclonal antibodies, Skin disorder therapies, Vascular disorder therapies
  • Target Complement C5a; Inflammation mediator
  • Mechanism of Action Complement C5a inhibitors; Inflammation mediator modulators
  • WHO ATC code

    D11 (Other Dermatological Preparations)

    J01X (Other Antibacterials)

    L01 (Antineoplastic Agents)

    L01X-C (Monoclonal antibodies)

    L04 (Immunosuppressants)

    M01A (Antiinflammatory and Antirheumatic Products, Non-steroids)

    R07A (Other Respiratory System Products)

  • EPhMRA code

    D11 (Other Dermatological Preparations)

    J1X (Other Antibacterials)

    L1 (Antineoplastics)

    L1G (Monoclonal Antibody Antineoplastics)

    L4 (Immunosuppressants)

    M1 (Anti-Inflammatory and Anti-Rheumatic Products)

    R7 (Other Respiratory System Products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections with severely progressed pneumonia - Phase II/III Netherlands Parenteral / unspecified InflaRx 01 Apr 2020
Cancer - - Preclinical Germany IV / unspecified InflaRx 30 Nov 2018
Granulomatosis with polyangiitis add-on to standard of care Adjunctive treatment Phase II Canada, USA IV / Infusion InflaRx 23 Aug 2019
Granulomatosis with polyangiitis - In adults, In the elderly Phase II Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom IV / Infusion InflaRx 22 Mar 2019
Hidradenitis suppurativa - - Phase II Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland, USA IV / Infusion InflaRx 26 Feb 2018
Hidradenitis suppurativa - - Preclinical Germany SC / unspecified InflaRx 23 May 2019
Inflammation Viral inflammation - No development reported (I) Germany IV / Infusion InflaRx 28 Apr 2019
Microscopic polyangiitis add-on to standard of care Adjunctive treatment Phase II Canada, USA IV / Infusion InflaRx 23 Aug 2019
Microscopic polyangiitis - In adults, In the elderly Phase II Belgium, Czech Republic, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, United Kingdom IV / Infusion InflaRx 23 May 2019
Microscopic polyangiitis - - Phase II USA IV / Infusion InflaRx 01 May 2019
Pyoderma gangrenosum - - Phase II Canada IV / Infusion InflaRx 01 May 2019
Pyoderma gangrenosum - - Phase I Germany IV / Infusion InflaRx 23 May 2019
Sepsis - Newly diagnosed Phase II Germany IV / Infusion InflaRx 23 Dec 2013
Systemic inflammatory response syndrome Systemic inflammatory response induced organ dysfunction in complex cardiac surgery - Phase II Germany IV / Infusion InflaRx 03 Mar 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
InflaRx Originator Germany
Beijing Mabworks Biotech Originator China
InflaRx Owner Germany
Beijing Mabworks Biotech Owner China

Scientific Summary

Adverse Events

In a phase IIa trial in patients with moderate to severe hidradenitis suppurativa, treatment with weekly intravenous IFX 1 was well tolerated, with no related adverse events, as well as no infusion-related, allergic or anaphylactic reactions [9] [11] .

Therapeutic Trials

Treatment with IFX 1 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 [34] [12] [9] [11] .

In a phase IIa trial conducted in patients with pyoderma gangrenosum (PG), two of five patients treated with IFX 1 achieved complete closure of the target ulcer and complete healing of all other PG ulcers [3] [22] .

Future Events

Expected Date Event Type Description Updated
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 [1] 05 May 2020
31 Mar 2018 Trial Update InflaRx plans a phase IIb trial in Hidradenitis Suppurativa in USA and other countries (Trial profile 700288579) [8] 12 Mar 2018

Development History

Event Date Update Type Comment
21 May 2020 Scientific Update Efficacy data from a phase IIa trial in Pyoderma gangrenosum released by InflaRx [3] Updated 28 May 2020
29 Apr 2020 Trial Update InflaRx plans a phase IIa trial for undisclosed tumour (Combination therapy) (IV) [1] Updated 15 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 15 May 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 [1] Updated 05 May 2020
28 Apr 2020 Licensing Status InflaRx and Merck enters clinical collaboration to conduct clinical trial of IFX-1 in combination with pembrolizumab [1] Updated 15 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 IFX 1 in COVID-2019 infections in Netherlands [4] Updated 06 Apr 2020
31 Mar 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections in Netherlands (Parenteral) (NCT04333420) [4] 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 [14] Updated 20 Aug 2019
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 [12] 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) [12] Updated 07 Jun 2019
23 May 2019 Trial Update InflaRx plans a phase IIa trial in Pyoderma Gangraenosum in Canada (IV) [12] Updated 07 Jun 2019
01 May 2019 Phase Change - II Phase-II clinical trials in Microscopic polyangiitis in USA (IV) [12] 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
22 Mar 2019 Phase Change - II Phase-II clinical trials in Wegener's granulomatosis (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 [16] 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 [10] (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 IFX 1 in ANCA-associated vasculitis (AAV) [15] 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) [7] (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) [8] Updated 12 Mar 2018
09 Jan 2018 Regulatory Status The US FDA approves IND application for IFX 1 in Hidradenitis Suppurativa [8] 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 [9] Updated 11 Sep 2017
07 Sep 2017 Trial Update InflaRx plans a phase IIb trial in Hidradenitis suppurativa [9] 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) [23] Updated 27 Jul 2016
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 [27] Updated 19 Jan 2012
28 Mar 2011 Phase Change - I Phase-I clinical trials in Sepsis in Germany (IV) Updated 08 Apr 2011

References

  1. InflaRx Reports Full Year 2019 Financial & Operating Results.

    Media Release
  2. A Pragmatic Adaptive Open Label, Randomized Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

    ctiprofile
  3. InflaRx Reports Q1 2020 Financial & Operating Results.

    Media Release
  4. InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRxs anti-C5a Technology.

    Media Release
  5. InflaRx Reports Additional Analysis of the SHINE Phase IIb Results for IFX-1 in Hidradenitis Suppurativa.

    Media Release
  6. A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

    ctiprofile
  7. InflaRx announces first patient enrolled in Phase IIb trial with lead candidate IFX-1 in Hidradenitis Suppurativa.

    Media Release
  8. InflaRx receives IND acceptance to proceed with a Phase IIb Trial with lead candidate IFX-1 in Hidradenitis Suppurativa.

    Media Release
  9. InflaRx Reports Topline Phase IIa Clinical Results of IFX-1 for the Treatment of Hidradenitis Suppurativa.

    Media Release
  10. InflaRx N.V. Reports Third Quarter 2018 Financial & Operating Results.

    Media Release
  11. An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa

    ctiprofile
  12. InflaRx Reports First Quarter 2019 Financial & Operating Results.

    Media Release
  13. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

    ctiprofile
  14. InflaRx Reports Second Quarter 2019 Financial & Operating Results.

    Media Release
  15. InflaRx Receives IND Approval from the FDA to Start its Phase II Clinical Trial of IFX-1 in ANCA-Associated Vasculitis.

    Media Release
  16. InflaRx Receives European Approval to Initiate Phase II Clinical Trial with IFX-1 in ANCA-Associated Vasculitis.

    Media Release
  17. InflaRx Commences Second Phase II Clinical Trial of IFX-1 in ANCA-Associated Vasculitis with First Patient Treated in Europe.

    Media Release
  18. A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

    ctiprofile
  19. Merkel P, Hellmich B, Jayne D, Ruckinger S, Tamas Z, Thielert C, et al. Design of a Phase 2, Multicenter, Randomized, Double- Blind, Placebo- Controlled Trial of 2 Different Dose Regimens of IFX- 1, a C5a Inhibitor, as an Add- On Therapy for Granulomatosis with Polyangiitis or Microscopic Polyangiitis . ACR/ARHP-2019 2019; abstr. 1680.

    Available from: URL: https://www.rheumatology.org/Annual-Meeting
  20. InflaRx Initiates Phase II Clinical Trial with IFX-1 in ANCA-Associated Vasculitis with First Patient Dosing.

    Media Release
  21. InflaRx Treats First Patient in Phase IIa Clinical Trial with Lead Candidate IFX-1 in Pyoderma Gangraenosum.

    Media Release
  22. Open Label Exploratory Phase 2a Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Subjects With Pyoderma Gangrenosum

    ctiprofile
  23. 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.

    Media Release
  24. 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

    ctiprofile
  25. InflaRx announces positive phase IIa top-line results from the SCIENS trial investigating IFX-1, a first-in-class anti-complement C5a antibody.

    Media Release
  26. 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

    ctiprofile
  27. InflaRx Announces Successful Conduct of Its Clinical Phase I Trial with IFX-1, a New Monoclonal Antibody Inhibiting Complement Driven Inflammation.

    Media Release
  28. 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

    ctiprofile
  29. 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
  30. InflaRx Full Year 2018 Financial & Operating Results.

    Media Release
  31. InflaRx N.V. Announces Proposed Primary and Secondary Offerings of Common Shares.

    Media Release
  32. InflaRx Closes Funding to Move Its Complement Antibody Program into Clinical Trials for Sepsis Treatment.

    Media Release
  33. InflaRx Raises Financing to Develop a New Therapeutic Approach against Sepsis.

    Media Release
  34. InflaRx Announces Presentation of New Clinical Data with Lead Candidate IFX-1 in Hidradenitis Suppurativa.

    Media Release
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