InflaRx Announces Publication of Phase 1 Data Demonstrating Favorable Safety and Pharmacokinetic/Pharmacodynamic Profile of Izicopan
Key Highlights
- ➤86-participant Phase 1 study published in peer-reviewed journal Clinical Pharmacology in Drug Development
- ➤Izicopan well tolerated across 3mg to 240mg single doses and 14-day multiple dosing
- ➤Single doses of at least 10mg generally achieved over 90% C5a blockade within two to four hours
- ➤30mg or 90mg twice-daily dosing exceeded 95% blockade from Day 2 through Day 15
- ➤InflaRx plans Phase 2 development in ANCA-associated vasculitis and additional renal indications
Expert Statements
Niels Riedemann, Chief Executive Officer and Founder of InflaRx
“Publication of these Phase 1 results further supports izicopan’s differentiated profile. Izicopan demonstrated rapid and sustained inhibition of C5a/C5aR1 signaling, favorable pharmacokinetic properties and a strong safety and tolerability profile across the doses evaluated. Together, these findings provide a solid clinical pharmacology foundation for our Phase 2 programs and reinforce the potential of izicopan as an oral therapy for patients with serious immune-inflammatory diseases driven by excessive C5a signaling.”
* Izicopan achieved rapid and sustained inhibition of C5a/C5aR1 signaling * Pharmacokinetic results demonstrated dose-dependent exposure, with izicopan well tolerated across all single and multiple doses evaluated * Findings support Phase 2 development of izicopan in immune-inflammatory diseases Jena, Germany, Nov. 06, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced the peer-reviewed publication of first-in-human Phase 1 clinical data for izicopan, formerly known as INF904, the Company’s orally administered, next-generation small molecule inhibitor of the C5a receptor (C5aR1). The publication reports results from the Company’s single ascending dose (SAD) and multiple ascending dose (MAD) study in 86 healthy participants. The positive results of these studies were previously announced.
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