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InflaRx N.V. (IFRX)

InflaRx N.V. is a clinical-stage biopharmaceutical firm dedicated to discovering and developing novel inhibitors leveraging C5a technology, primarily operating in Germany and the United States. The company's focus on C5a stems from its critical role as an inflammatory mediator implicated in the progression of various autoimmune and inflammatory diseases. Its primary product candidate, vilobelimab, is an innovative, first-in-class anti-C5a monoclonal antibody delivered intravenously. Vilobelimab has progressed through several clinical stages for multiple indications: It has successfully completed a Phase III clinical trial for hidradenitis suppurativa (HS), a rare, chronic, and debilitating systemic inflammatory skin condition. It is currently undergoing Phase II trials for anti-neutrophil cytoplasm antibody associated vasculitis (AAV), a rare and life-threatening autoimmune disorder, and for PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). An exploratory Phase IIa study is also underway for pyoderma gangraenosum (PG), a chronic inflammatory skin disorder. Beyond its lead candidate, InflaRx is also advancing INF904, an oral, small molecule drug candidate targeting undisclosed chronic inflammatory and autoimmune diseases, and IFX002, which is in preclinical development for chronic inflammation and autoimmune conditions. Strategic collaborations include a co-development agreement with Beijing Defengrei Biotechnology Co. Ltd. and a clinical trial collaboration and supply agreement with Merck & Co. Inc. Established in 2007, the company, initially known as Fireman B.V., officially became InflaRx N.V. in 2017. It maintains its headquarters in Jena, Germany, with operations extending to the United States.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

InflaRx N.V. logo

InflaRx N.V.

NASDAQ:IFRXHealthcare
-3.21%$1.66
AH$1.66+0.00%vs close
Mkt Cap$244.63M
Float120.11M
O/S147.37M
Vol
$ Vol
RVOL
Inst Own64.2%
SI10.6%
Earnings
Dilution
Phase Distribution
12 lead-sponsored trials·0 active·8 completed
Phase 11
Phase 29
Phase 2/31
Phase 31
(4 more as collaborator)
Status Overview
Completed8
Stopped4

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Terminated

    Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

    vilobelimab, Placebo

    Pyoderma Gangrenosum

    Enrollment
    54
    Start
    Nov 2023
    Primary Completion
    Jul 2025
    Completion
    Jul 2025
    NCT05964413
  • Phase 2/3
    Completed

    Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

    IFX-1 + BSC, BSC

    Severe COVID-19 Pneumonia

    Enrollment
    399
    Start
    Mar 2020
    Primary Completion
    Oct 2021
    Completion
    Dec 2021
    NCT04333420
  • Phase 2
    Completed

    Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

    CaCP29, Placebo

    Severe Sepsis, Septic Shock

    Enrollment
    72
    Start
    Apr 2014
    Primary Completion
    Dec 2015
    Completion
    Dec 2015
    NCT02246595
  • Phase 2
    Completed

    Studying Complement Inhibition in Complex Cardiac Surgery

    IFX-1, Placebo

    Systemic Inflammatory Response Syndrome, C.Surgical Procedure; Cardiac

    Enrollment
    116
    Start
    May 2016
    Primary Completion
    Dec 2016
    Completion
    Jan 2017
    NCT02866825
  • Phase 2
    Completed

    Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

    IFX-1

    Hidradenitis Suppurativa

    Enrollment
    12
    Start
    Dec 2016
    Primary Completion
    Jul 2017
    Completion
    Jul 2017
    NCT03001622
  • Phase 2
    Completed

    Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

    IFX-1, Placebo

    Hidradenitis Suppurativa (HS)

    Enrollment
    179
    Start
    Feb 2018
    Primary Completion
    May 2019
    Completion
    Jan 2020
    NCT03487276
  • Phase 2
    Terminated

    Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA

    IFX-1 low dose, IFX-1 high dose

    Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)

    Enrollment
    20
    Start
    Oct 2018
    Primary Completion
    Sep 2020
    Completion
    May 2021
    NCT03712345
  • Phase 2
    Completed

    Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

    IFX-1, Placebo-IFX-1

    Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)

    Enrollment
    57
    Start
    Apr 2019
    Primary Completion
    Apr 2021
    Completion
    Jun 2021
    NCT03895801
  • Phase 2
    Completed

    Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum

    vilobelimab

    Pyoderma Gangrenosum

    Enrollment
    19
    Start
    May 2019
    Primary Completion
    Jan 2022
    Completion
    Jan 2022
    NCT03971643
  • Phase 2
    Terminated

    Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.

    Vilobelimab, Vilobelimab + pembrolizumab combination therapy

    SCC - Squamous Cell Carcinoma of Skin

    Enrollment
    30
    Start
    Mar 2021
    Primary Completion
    Jun 2024
    Completion
    Jun 2024
    NCT04812535
  • Phase 2
    Terminated

    Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

    CSU lower dose treatment, CSU high dose treatment

    Chronic Urticaria, Idiopathic, Hidradenitis +1

    Enrollment
    73
    Start
    Jan 2025
    Primary Completion
    Jan 2026
    Completion
    Jan 2026
    NCT06555328
  • Phase 1
    Completed

    Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29

    CaCP29, a humanized monoclonal antibody

    Drug Safety

    Enrollment
    26
    Start
    Mar 2011
    Primary Completion
    Oct 2011
    Completion
    Oct 2011
    NCT01319903