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.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Terminated
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
vilobelimab, Placebo
Pyoderma Gangrenosum
NCT05964413Enrollment54StartNov 2023Primary CompletionJul 2025CompletionJul 2025 - Phase 2/3Completed
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
IFX-1 + BSC, BSC
Severe COVID-19 Pneumonia
NCT04333420Enrollment399StartMar 2020Primary CompletionOct 2021CompletionDec 2021 - Phase 2Completed
Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction
CaCP29, Placebo
Severe Sepsis, Septic Shock
NCT02246595Enrollment72StartApr 2014Primary CompletionDec 2015CompletionDec 2015 - Phase 2Completed
Studying Complement Inhibition in Complex Cardiac Surgery
IFX-1, Placebo
Systemic Inflammatory Response Syndrome, C.Surgical Procedure; Cardiac
NCT02866825Enrollment116StartMay 2016Primary CompletionDec 2016CompletionJan 2017 - Phase 2Completed
Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
IFX-1
Hidradenitis Suppurativa
NCT03001622Enrollment12StartDec 2016Primary CompletionJul 2017CompletionJul 2017 - Phase 2Completed
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
IFX-1, Placebo
Hidradenitis Suppurativa (HS)
NCT03487276Enrollment179StartFeb 2018Primary CompletionMay 2019CompletionJan 2020 - Phase 2Terminated
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)
NCT03712345Enrollment20StartOct 2018Primary CompletionSep 2020CompletionMay 2021 - Phase 2Completed
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)
NCT03895801Enrollment57StartApr 2019Primary CompletionApr 2021CompletionJun 2021 - Phase 2Completed
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
vilobelimab
Pyoderma Gangrenosum
NCT03971643Enrollment19StartMay 2019Primary CompletionJan 2022CompletionJan 2022 - Phase 2Terminated
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
NCT04812535Enrollment30StartMar 2021Primary CompletionJun 2024CompletionJun 2024 - Phase 2Terminated
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
NCT06555328Enrollment73StartJan 2025Primary CompletionJan 2026CompletionJan 2026 - Phase 1Completed
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
CaCP29, a humanized monoclonal antibody
Drug Safety
NCT01319903Enrollment26StartMar 2011Primary CompletionOct 2011CompletionOct 2011
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Terminated | vilobelimab, Placebo | NCT05964413 |
| Phase 2/3 | Completed | IFX-1 + BSC, BSC | NCT04333420 |
| Phase 2 | Completed | CaCP29, Placebo | NCT02246595 |
| Phase 2 | Completed | IFX-1, Placebo | NCT02866825 |
| Phase 2 | Completed | IFX-1 | NCT03001622 |
| Phase 2 | Completed | IFX-1, Placebo | NCT03487276 |
| Phase 2 | Terminated | IFX-1 low dose, IFX-1 high dose | NCT03712345 |
| Phase 2 | Completed | IFX-1, Placebo-IFX-1 | NCT03895801 |
| Phase 2 | Completed | vilobelimab | NCT03971643 |
| Phase 2 | Terminated | Vilobelimab, Vilobelimab + pembrolizumab combination therapy | NCT04812535 |
| Phase 2 | Terminated | CSU lower dose treatment, CSU high dose treatment | NCT06555328 |
| Phase 1 | Completed | CaCP29, a humanized monoclonal antibody | NCT01319903 |