JENA, Germany, June 05, 2024 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company specializing in anti-inflammatory therapeutics targeting the complement system, hosted a virtual R&D event spotlighting its oral small molecule C5aR inhibitor, INF904. The event featured leading experts in complement inhibition, chronic spontaneous urticaria (CSU), and hidradenitis suppurativa (HS), who provided insights into the development rationales, potential differentiation, and the broader medical implications of INF904.
Key opinion leaders (KOLs) presenting at the event included Prof. Dr. Marcus Maurer (Charité – Universitätsmedizin Berlin), Dr. Christopher Sayed (University of North Carolina), and Prof. Dr. Jörg Köhl (University of Lübeck).
Phase 2a Trial and Market Opportunities
InflaRx revealed additional details on the Phase 2a trial design for INF904 targeting moderate-to-severe CSU and HS. This multi-center, open-label study will dose 75 patients with different INF904 regimens over four weeks, followed by an additional four-week observation period. The trial aims to generate safety and pharmacokinetic (PK) data, alongside preliminary efficacy results, with data expected by summer 2025.
The commercial potential for CSU and HS is significant, representing multi-billion-dollar market opportunities. InflaRx’s financial stability is projected to support operations into 2026, facilitating the advancement of its clinical programs.
Expert Commentary
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, stated, “We are excited to share our development plans for INF904, which we believe has tremendous potential to address significant unmet medical needs. Our initial focus on CSU and HS reflects our strategy to bring innovative treatments to patients swiftly, and we are optimistic about achieving key milestones in 2025.”
Clinical Development Program
The Phase 2a basket trial will begin by the end of 2024, involving patients with moderate-to-severe CSU and HS. For the CSU cohort, patients will be randomized into three groups receiving 30 mg, 90 mg BID, and 90 mg BID for anti-IgE non-responders. Efficacy measures include changes in Urticaria Activity Score 7 (UAS7), Hives Severity Score (HSS7), and Itch Severity Score (ISS7).
In the HS cohort, patients will be randomized to receive 30 mg, 60 mg, or 90 mg BID. Efficacy measures will focus on changes in abscess, inflammatory nodule, and draining tunnel counts, as well as related quality of life metrics.
Broader Therapeutic Potential
INF904 is seen as a “pipeline-in-a-product” with potential applications beyond immuno-dermatology, including nephrology, neurology, and hematology. While the immediate focus remains on CSU and HS, InflaRx continues to evaluate opportunities for future collaborations to explore additional therapeutic areas.
About INF904
INF904 is an orally administered small molecule inhibitor targeting C5aR. Pre-clinical models have demonstrated its anti-inflammatory effects, with minimal inhibition of CYP3A4/5 enzymes. A first-in-human study showed that INF904 is well-tolerated with no significant safety concerns, supporting its potential as a best-in-class treatment.
For more information and to access the presentation slide deck, visit InflaRx’s website.
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