izicopan (INF904)
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InflaRx Announces Participation in the Raymond James 2026 Biotech Innovation Symposium
Globenewswire· 2026-03-31 11:30
Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [2] - The company utilizes proprietary anti-C5a and anti-C5aR technologies to create specific inhibitors of the complement activation factor C5a and its receptor [2] - InflaRx's lead program is izicopan (INF904), an orally administered small molecule inhibitor that has shown promising pharmacokinetic and pharmacodynamic characteristics in clinical studies [2] Product Development - Izicopan is being developed for the treatment of various inflammatory diseases, including hidradenitis suppurativa [2] - The company has also developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated clinical activity and tolerability in multiple studies [2] Corporate Information - InflaRx was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [3] - InflaRx GmbH and InflaRx Pharmaceuticals Inc. are wholly owned subsidiaries of InflaRx N.V. [3] Upcoming Events - InflaRx will participate in the Raymond James 2026 Biotech Innovation Symposium on April 14, 2026, in New York, NY, where the company will hold one-on-one investor meetings [1]
InflaRx to Report Full Year 2025 Results on March 19, 2026
Globenewswire· 2026-03-12 11:30
Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [2] - The company utilizes proprietary anti-C5a and anti-C5aR technologies to create specific inhibitors of the complement activation factor C5a and its receptor [2] - InflaRx's lead program is izicopan (INF904), an orally administered small molecule inhibitor that has shown promising pharmacokinetic and pharmacodynamic characteristics in clinical studies [2] Product Development - Izicopan is being developed for the treatment of several inflammatory diseases, including hidradenitis suppurativa [2] - The company has also developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated clinical activity and tolerability in multiple studies [2] Financial Information - InflaRx will publish its financial and operating results for the fourth quarter and full year 2025 on March 19, 2026, before the market opens [1]
InflaRx Announces Participation in the Leerink Partners Global Healthcare Conference
Globenewswire· 2026-02-26 12:30
Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [2] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [3] Product Development - InflaRx's lead program is izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling, which has shown promising pharmacokinetic and pharmacodynamic characteristics in Phase 1 and Phase 2a clinical studies [2] - The company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa [2] - InflaRx has also developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies [2] Upcoming Events - InflaRx will participate in the Leerink Partners Global Healthcare Conference from March 8 to 11, 2026, in Miami, FL, with a fireside chat scheduled for March 9 at 9:20 AM ET [1]
InflaRx Announces Participation in February Investor Conferences
Globenewswire· 2026-01-29 12:30
Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system [3] - The company utilizes proprietary anti-C5a and anti-C5aR technologies to create specific inhibitors of the complement activation factor C5a and its receptor [3] - InflaRx's lead program is izicopan (INF904), an orally administered small molecule inhibitor that has shown promising pharmacokinetic and pharmacodynamic characteristics in clinical studies [3] - The company is also developing vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated clinical activity and tolerability [3] Upcoming Events - InflaRx will participate in the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, with a fireside chat scheduled for February 11 at 11:30 AM ET [1] - The company will conduct one-on-one investor meetings on February 11 during the same summit [1] - InflaRx will also present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a virtual presentation on February 25 at 8:40 AM ET [2] - One-on-one investor meetings will also be held on February 25 [2]
InflaRx Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum
Globenewswire· 2025-12-30 12:30
Core Insights - InflaRx N.V. has conducted multiple data analyses of its Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated due to futility as recommended by the Independent Data Monitoring Committee (IDMC) [1][7] Study Overview - The Phase 3 study enrolled 54 patients, with 30 completing 6 months of treatment. The primary endpoint of complete target ulcer closure showed a difference of 20.8% for vilobelimab versus 16.7% for placebo, though this was not statistically significant [3] - Key secondary endpoints indicated improvement for vilobelimab, including complete disease remission (20.8% vs. 5.6%, p=NS) and >50% reduction in target ulcer volume at week 26 (36.4% vs. 16.7%, p=NS) [3] Efficacy Signals - Post-hoc analyses revealed an overall treatment effect with vilobelimab, showing an average percent change in target ulcer volume of -45.4% (p=0.0428) from Weeks 2 to 26 [4] - Significant treatment differences were noted from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab compared to placebo [4] Tolerability and Safety - Vilobelimab was well tolerated, with treatment-emergent adverse events (TEAEs) mostly mild to moderate. Serious related TEAEs were reported at 6.3% in the vilobelimab arm and 4.5% in the placebo arm [3] Future Development Plans - InflaRx plans to meet with the FDA to discuss potential development pathways for vilobelimab in PG, which may involve collaboration with a partner [7][9] - The company is prioritizing the development of izicopan (INF904) and does not expect to allocate significant resources towards vilobelimab's development independently [9] Company Background - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary technologies to develop inhibitors of the complement activation factor C5a and its receptor [11] - Vilobelimab is a first-in-class monoclonal antibody targeting C5a, demonstrating disease-modifying clinical activity in various studies [10]
InflaRx Announces International Nonproprietary Name of “Izicopan” for INF904
Globenewswire· 2025-12-11 12:30
Core Viewpoint - InflaRx N.V. has received the international nonproprietary name "izicopan" for its C5aR inhibitor, previously known as INF904, from the World Health Organization, indicating a significant step in the drug's development process [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics by targeting the complement system, specifically through its proprietary anti-C5a and anti-C5aR technologies [4] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, and is also advancing izicopan (INF904), an orally administered small molecule inhibitor [4][5] Product Details - Izicopan (INF904) is an orally administered small molecule that inhibits the C5a receptor, demonstrating anti-inflammatory effects in pre-clinical models and human studies [3] - Clinical trials have shown izicopan to be well tolerated, with no safety concerns reported across various dosing regimens, including single doses from 3 mg to 240 mg and multiple doses from 30 mg to 90 mg for 14 days [3] - Phase 2a data indicates that izicopan has the potential for best-in-class efficacy, achieving over 90% blockade of C5a-induced neutrophil activation during the dosing period [3] Clinical Efficacy - In patients with hidradenitis suppurativa, izicopan treatment resulted in significant reductions in abscesses and nodules, with improvements in pain scores and sustained responses observed four weeks post-treatment [3] - For chronic spontaneous urticaria, substantial reductions in the Urticaria Activity Score (UAS7) were noted, particularly among patients with severe disease, indicating improved disease control [3]