Anti - inflammatory therapeutics
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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 Highlights Clinical Activity of Vilobelimab in Pyoderma Gangrenosum in Late-Breaker Oral Presentation at 2026 American Academy of Dermatology Annual Meeting
Globenewswire· 2026-03-30 11:30
Core Insights - InflaRx N.V. announced positive data from a Phase 3 study of vilobelimab for pyoderma gangrenosum, presented at the 2026 AAD Annual Meeting [1][2] Group 1: Study Results - The Phase 3 trial showed higher rates of complete remission (20.8% for vilobelimab vs. 5.1% for placebo) and target ulcer closure (20.8% vs. 16.7%) [4] - Over one-third of vilobelimab-treated patients achieved more than a 50% reduction in ulcer volume (36.4% vs. 16.7% for placebo) [4] - Vilobelimab treatment significantly reduced C5a levels by -76.6% compared to -13.5% with placebo [5] Group 2: Safety Profile - The treatment was generally well tolerated, with most adverse events being mild to moderate, and similar rates of serious adverse events (6.3% for vilobelimab vs. 4.5% for placebo) [5] Group 3: Future Development - InflaRx is prioritizing discussions with the FDA regarding izicopan for hidradenitis suppurativa while also planning to explore development options for vilobelimab in pyoderma gangrenosum, likely in collaboration with a partner [6] Group 4: Product Information - Vilobelimab is a first-in-class monoclonal antibody targeting complement factor C5a, designed to block its biological activity while preserving the innate immune system's defense mechanisms [7][9]
InflaRx Reports Full Year 2025 Results and Highlights Key Achievements and Expected Milestones
Globenewswire· 2026-03-19 11:30
Core Viewpoint - InflaRx N.V. is focusing its resources on izicopan, an anti-inflammatory therapeutic, following positive Phase 2a results in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) [2][3] Financial Results - For the year ended December 31, 2025, InflaRx reported a net loss of €45.6 million, or €0.68 per ordinary share, compared to a net loss of €46.1 million, or €0.78 per ordinary share, for 2024 [20] - Total funds available as of December 31, 2025, amounted to approximately €46.2 million, which includes €16.0 million in cash and cash equivalents and €30.2 million in marketable securities [21] - Marketing and sales expenses decreased by €2.3 million to €4.5 million for the year ended December 31, 2025, primarily due to lower external service costs [15] - Research and development expenses decreased by €9.6 million to €25.7 million, mainly due to lower costs from manufacturing development activities and clinical trials [16] Business Update - InflaRx is in active discussions with the FDA regarding the design of a Phase 2b trial for izicopan in HS and expects to finalize communications soon [2][3] - The company plans to conduct a pharmacokinetic bridging study in China to expedite proof-of-concept studies for izicopan in additional indications [6] - InflaRx aims to host a virtual Capital Markets Day to provide insights into izicopan's clinical development path and market opportunities [4] Clinical Development - Izicopan has shown promising Phase 2a data, indicating rapid and meaningful reductions in abscesses and nodules in HS, with improvements in various clinical measures [7][9] - In CSU, izicopan demonstrated improvements in clinical measures that exceed historical placebo levels, particularly in patients with severe disease [10] - The company is considering further development of izicopan in CSU, with a potential market opportunity exceeding $1 billion [10] Pipeline and Strategy - InflaRx is reviewing additional development opportunities for izicopan in ANCA-associated vasculitis (AAV), highlighting its best-in-class potential due to its differentiated safety profile [5][8] - The company is actively engaging with potential collaborators to expedite its pipeline development goals [8]
InflaRx Announces Late-Breaker Oral Presentation on Vilobelimab Phase 3 Results in Pyoderma Gangrenosum at 2026 American Academy of Dermatology Annual Meeting
Globenewswire· 2026-03-18 11:30
Core Insights - InflaRx N.V. announced an oral presentation of its Phase 3 study data for vilobelimab in pyoderma gangrenosum at the 2026 American Academy of Dermatology Annual Meeting [1][2] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5aR technologies to develop specific inhibitors targeting the complement activation factor C5a and its receptor C5aR [3] - The company's lead program is izicopan (INF904), an orally administered small molecule inhibitor that has shown promising pharmacokinetic and pharmacodynamic characteristics in Phase 1 and Phase 2a clinical studies [3] - InflaRx has also developed vilobelimab, a first-in-class anti-C5a monoclonal antibody that has demonstrated clinical activity and tolerability in multiple studies [3] Upcoming Presentation Details - The oral presentation titled "Vilobelimab Treatment for Ulcerative Pyoderma Gangrenosum: Results from a Multicenter, Randomized, Placebo Controlled Phase 3 Trial" will be presented by Dr. Benjamin Kaffenberger on March 28, 2026, from 2:24 to 2:36 PM MT at the Bellco Theatre 3 [2]
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 Announces Strategy Focused on Capital-Efficient Execution with Izicopan and Near-Term Value Creation
Globenewswire· 2026-01-08 13:00
Core Viewpoint - InflaRx N.V. is implementing cost-reduction measures to extend its cash runway and focus resources on the development of izicopan, a potential best-in-class C5aR inhibitor for hidradenitis suppurativa (HS) and other inflammatory and immunological (I&I) indications [1][2]. Financial and Operational Restructuring - The company is streamlining its organizational structure and discontinuing non-essential activities outside the development of izicopan to improve capital efficiency [3]. - InflaRx is reducing its workforce by approximately 30% and significantly cutting spending related to Gohibic (vilobelimab), which will incur a one-time charge of about $7 million, primarily a non-cash charge for inventory write-off [4]. - These actions are expected to create a leaner cost structure, allowing for substantial reductions in operating expenses and extending the cash runway to mid-2027 [4]. Development Focus on Izicopan - InflaRx is prioritizing resources for izicopan, which has shown a favorable pharmacokinetic/pharmacodynamic profile and potential to address HS, chronic spontaneous urticaria (CSU), and other I&I indications [7]. - The company is in active discussions with the FDA regarding the Phase 2b study design for izicopan in HS, aiming to differentiate it from existing therapies [8]. - A PK bridging study in China is planned for 2026 to expedite proof of concept studies for izicopan in additional geographies [12]. Clinical Progress and Future Plans - InflaRx continues to make progress toward Phase 2b readiness for izicopan in HS and plans to present Phase 2a datasets for izicopan in HS and CSU at medical conferences later this year [11][10]. - The company intends to host a virtual Capital Markets Day in spring 2026 to showcase the clinical utility and commercial potential of izicopan [13]. Product Overview - Izicopan (INF904) is an orally administered small molecule inhibitor of the C5a receptor, demonstrating anti-inflammatory effects in pre-clinical and human studies, with a favorable safety profile and significant efficacy in reducing symptoms in HS and CSU patients [14][15].
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]
InflaRx to Announce Topline Data from Phase 2a Clinical Trial of INF904 in Hidradenitis Suppurativa and Chronic Spontaneous Urticaria
Globenewswire· 2025-11-07 21:05
Core Insights - InflaRx N.V. is set to report topline data from its Phase 2a clinical trial of oral C5aR inhibitor INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) on November 10, 2025 [1] - The company will host a webcast/conference call on the same day to discuss the clinical data and feature insights from key opinion leaders [2] - InflaRx will also publish its third quarter 2025 financial and operating results via Form 6-K on the same day [3] Company Overview - InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics, utilizing proprietary anti-C5a and anti-C5aR technologies to develop specific inhibitors targeting the complement activation factor C5a and its receptor C5aR [4] - The company has developed vilobelimab, a first-in-class anti-C5a monoclonal antibody, and is also working on INF904, an orally administered small molecule inhibitor [4] - Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA [5]