InflaRx N.V. develops anti-inflammatory therapeutics that target the complement system through proprietary anti-C5a and anti-C5aR technologies. Its lead program, izicopan, is an orally administered small-molecule inhibitor of C5a-induced signaling via the C5a receptor, and vilobelimab is an intravenously delivered anti-C5a monoclonal antibody that selectively binds free C5a.
Company news commonly covers izicopan clinical-development strategy, preclinical pharmacology data, complement-mediated inflammatory disease programs, financial results, ordinary-share financings, Nasdaq listing compliance, annual meeting matters and investor communications. Updates also address the company’s operating group, which includes wholly owned subsidiaries in Germany and the United States.
InflaRx (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, announced it will release its Q3 2024 financial results on November 8, 2024, before market open. The company will also participate in the Guggenheim Securities Inaugural Healthcare Innovation Conference from November 11-13, 2024, in Boston, featuring a fireside chat on November 11th at 11:00 am ET. InflaRx specializes in developing inhibitors of complement activation factor C5a and its receptor C5aR, with their lead candidate vilobelimab and oral small molecule inhibitor INF904.
InflaRx presented a post hoc analysis of the SHINE Phase 2b study of vilobelimab in hidradenitis suppurativa (HS) at the 2024 EADV Congress. The analysis focused on the 1200 mg dose, which showed significant improvements compared to placebo at 16 weeks:
- 45.2% reduction in draining tunnels
- 25.1% reduction in total lesion count
- 31.6% reduction in International Hidradenitis Suppurativa Score 4
These results suggest meaningful clinical benefits for vilobelimab in HS and support using a modified version of the HiSCR that measures drug activity against all three lesion types, emphasizing the reduction of draining tunnels. The company believes this analysis provides insights into vilobelimab's potential to address underlying inflammation in HS.
InflaRx N.V. (Nasdaq: IFRX) presented preclinical data for its novel oral C5aR inhibitor, INF904, at the 2024 European Meeting on Complement in Human Diseases. The findings demonstrate INF904's significant anti-inflammatory properties and strong pharmacokinetic profile. In a hamster neutropenia model, INF904 inhibited C5a-induced neutropenia by 96.5% compared to 51.1% for the same dose of avacopan. INF904 also showed a 2- to 5-fold higher exposure than avacopan across all tested animal species and is a much weaker inhibitor of CYP3A4/5 enzymes.
Results from in vitro and in vivo inflammatory disease models indicated that INF904 reduces neutrophil activation and shows significant anti-inflammatory effects. A first-in-human study demonstrated that INF904 is well-tolerated with no safety signals of concern in single doses up to 240 mg and multiple doses up to 90 mg twice daily for 14 days.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, has announced its participation in two investor conferences in September 2024. The company will attend the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11 in New York, offering an on-demand virtual presentation and one-on-one investor meetings. Additionally, InflaRx will participate in the 2024 Cantor Global Healthcare Conference from September 17-19, featuring a fireside chat on September 18th at 9:45 am ET and investor meetings.
InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenously delivered anti-C5a monoclonal antibody that has shown promising clinical activity in various indications. The company is also developing INF904, an oral small molecule inhibitor of the C5a receptor.
InflaRx (Nasdaq: IFRX), a biopharmaceutical company focused on anti-inflammatory therapeutics, reported its Q2 2024 financial results and business update.
Key highlights include:
- R&D event on INF904's potential in inflammation & immunology.
- Phase 2a study for INF904 in CSU and HS expected by year-end 2024; Phase 2a data readout in summer 2025; Phase 2b trial initiation in 2025.
- Interim analysis for vilobelimab Phase 3 trial in PG expected in 2025.
- Vilobelimab selected for BARDA-sponsored ARDS trial.
- Cash and equivalents of €74.6 million, expected to fund operations into 2026.
Financials:
- Revenue: €42 thousand from GOHIBIC sales.
- Net loss: €23.5 million, compared to €19.3 million in the first half of 2023.
- R&D expenses: €17.3 million, down by €8.3 million year-over-year.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, has announced it will release its second quarter 2024 financial and operating results on August 8, 2024, before the market opens. No conference call is scheduled for this report.
InflaRx specializes in developing inhibitors of the complement activation factor C5a and its receptor C5aR. Their lead product candidate, vilobelimab, is an intravenously delivered anti-C5a monoclonal antibody that has shown promising clinical activity in various indications. The company is also developing INF904, an oral small molecule inhibitor of the C5a receptor.
Founded in 2007, InflaRx has offices in Jena and Munich, Germany, and Ann Arbor, MI, USA.
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company focusing on anti-inflammatory therapeutics, will present preclinical data on INF904, their novel oral C5aR inhibitor, at the 2024 European Meeting on Complement in Human Diseases (EMCHD) in Lübeck, Germany, from September 2-6, 2024. The company will showcase two poster presentations, participate in a C5a/C5aR-focused panel discussion, and speak at a satellite symposium.
INF904 is an orally administered, small molecule inhibitor of the C5a receptor that has demonstrated anti-inflammatory effects in preclinical models. A first-in-human study showed that INF904 is well-tolerated and exhibits no safety concerns in single doses from 3 mg to 240 mg or multiple doses from 30 mg QD to 90 mg BID for 14 days. The drug achieved ≥90% blockade of C5a-induced neutrophil activation over the 14-day dosing period, supporting its potential as a best-in-class treatment.
InflaRx announced that its drug GOHIBIC (vilobelimab) has been selected by BARDA for a Phase 2 clinical trial aimed at treating acute respiratory distress syndrome (ARDS). The trial will be conducted at around 60 U.S. sites, enrolling 600 adults with ARDS from various causes. Vilobelimab will be one of three drugs tested, with each drug's safety and efficacy evaluated separately against a placebo. Key endpoints include all-cause mortality at Day 28, hospitalization duration, ICU days, and other efficacy measures. The results will inform Phase 3 trial designs and identify patient subpopulations likely to benefit from these treatments.
InflaRx hosted a virtual R&D event showcasing their oral small molecule C5aR inhibitor, INF904. The event detailed its potential in treating Chronic Spontaneous Urticaria (CSU) and Hidradenitis Suppurativa (HS), both representing multi-billion-dollar markets. INF904's Phase 2a clinical trial for CSU and HS will start by late 2024, with results expected by summer 2025. The trial aims to evaluate safety, pharmacokinetics, and clinical benefits. InflaRx expects their strong financial position to fund operations into 2026, supporting further clinical advancements. The company sees INF904 as a pipeline-in-a-product, potentially addressing broader therapeutic areas.
InflaRx N.V. (Nasdaq: IFRX) presented new data at the ATS 2024 International Conference showing significant improvements in mortality rates for critically ill COVID-19 patients treated with vilobelimab in combination with tocilizumab or baricitinib. The analysis, derived from the PANAMO Phase III trial, demonstrates an 84.6% relative reduction in 28-day all-cause mortality and a 66.7% relative reduction in 60-day all-cause mortality compared to placebo. Safety assessments revealed no major concerns related to the combination therapy. This data further supports the FDA's emergency use authorization for vilobelimab in critically ill COVID-19 patients.