GlobeNewswire·Nov 6, 2026, 7:30 AM ET

InflaRx Announces Publication of Phase 1 Data Demonstrating Favorable Safety and Pharmacokinetic/Pharmacodynamic Profile of Izicopan

IFRX

InflaRx published peer-reviewed Phase 1 clinical data for izicopan (formerly INF904), an oral C5a receptor inhibitor, in the journal Clinical Pharmacology in Drug Development.
The study evaluated 86 healthy participants in a randomized, placebo-controlled design involving single & multiple ascending doses.
Izicopan demonstrated rapid & sustained inhibition of C5a/C5aR1 signaling with dose-dependent pharmacokinetic exposure.
The drug was well tolerated across single doses of 3 mg to 240 mg & multiple doses of 30 mg once daily, 30 mg twice daily, & 90 mg twice daily for 14 days.
Adverse events were mild to moderate in severity with no serious adverse events or dose-dependent safety patterns observed.
No clinically relevant changes occurred in clinical laboratory parameters, vital signs, ECGs, telemetry, or physical examinations.
Single doses of at least 10 mg produced greater than 90% blockade of C5a-induced CD11b upregulation within 2 to 4 hours.
Multiple dosing of 30 mg or 90 mg twice daily maintained blockade exceeding 95% from Day 2 through Day 15.
Plasma exposure increased with dose across the 3 mg to 240 mg range with maximum concentrations reached approximately 3.5 to 6 hours post-dosing.
Izicopan does not exhibit time-dependent inhibition of CYP3A4/5 & showed a favorable reactive metabolite profile in human liver microsomes.
Prior Phase 2a data indicated clinically meaningful reductions in symptoms for hidradenitis suppurativa & chronic spontaneous urticaria.
InflaRx plans to advance izicopan into Phase 2 development for ANCA-associated vasculitis & additional renal indications.
The company intends to leverage izicopan's oral administration & differentiated safety profile to compete with existing C5aR inhibitors.

Company: InflaRx N.V.
Keywords: Nasdaq:IFRX, InflaRx N.V., InflaRx, Phase 1, izicopan