
Clinical TrialMay 4, 2026, 07:33 AM
InflaRx's Izicopan Shows Low Reactive Metabolite Formation in Pre-clinical Data
AI Summary
InflaRx N.V. announced new pre-clinical data for its investigational oral C5aR1 inhibitor, izicopan, demonstrating minimal reactive metabolite formation in human liver microsomes. This suggests a lower potential for bioactivation-related safety risks compared to the marketed comparator, avacopan, which showed higher levels of thiol adducts. These findings support izicopan's differentiated profile, building on previous positive Phase 1 and Phase 2a clinical data indicating good tolerability and efficacy in conditions like hidradenitis suppurativa and chronic spontaneous urticaria. The company believes these properties may contribute to its overall differentiation within the C5aR inhibitor class.
Key Highlights
- Izicopan demonstrated minimal reactive metabolite formation in human liver microsomes.
- Avacopan showed higher levels of thiol adducts under the same experimental conditions.
- Differences in reactive conjugate peak areas exceeded 100-fold at early time points (5 and 10 minutes).
- Differences remained approximately 10-fold at 20 and 40 minutes of incubation.
- Izicopan does not inhibit the cytochrome P450 3A4 (CYP3A4) enzyme.
- Phase 1 study showed izicopan was well tolerated in doses from 3 mg to 240 mg (single) and 30 mg to 90 mg (multiple).
- Achieved >=90% blockade of C5a-induced neutrophil activation over 14 days.
- Phase 2a data showed rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs) in hidradenitis suppurativa.
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