Jena, Germany — May 6, 2026 — Leads & Copy —
InflaRx N.V. (Nasdaq: IFRX) announced its intention to develop izicopan in ANCA-associated vasculitis (AAV), a life-threatening kidney disorder. The company also plans to establish rapid proof of concept in additional life-threatening renal diseases.
InflaRx is planning Phase 2 trials for izicopan in AAV and evaluating various development approaches, including potentially expediting its path to market, to address the changing regulatory environment surrounding avacopan, the currently approved comparator.
The company intends to establish rapid proof of concept for izicopan across complement-mediated life-threatening kidney diseases by conducting open-label studies, with clinical data expected to be generated next year. These renal disease targets include atypical hemolytic uremic syndrome (aHUS), IgA nephropathy (IgAN), and C3 glomerulopathy (C3G).
InflaRx anticipates conducting a pharmacokinetic bridging study in China this year. The company estimates that it has sufficient funds for currently planned clinical development activities and ongoing operations through 2029.
InflaRx plans to host a Capital Markets Day this summer to provide further details on izicopan’s potential in AAV, aHUS, IgAN, and C3G. The company will also host a webcast on Friday, May 8, at 8:30 AM ET / 2:30 PM CET to discuss its new strategy in AAV and renal disease. Participants can pre-register for the webcast to receive an invite link and dial-in details.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, stated that the company chose to pursue development in AAV after evaluating the unmet need and izicopan’s potential as a differentiated C5aR inhibitor with potential advantages in efficacy, safety, and convenience. He added that InflaRx aims to establish proof of concept in other renal disorders due to the evidence supporting the role of the C5a/C5aR axis in multiple kidney diseases.
InflaRx has largely concluded its interactions with the FDA regarding an optimized clinical development program for izicopan in hidradenitis suppurativa (HS) and believes there is a viable path forward. The company sees HS as a significant opportunity for izicopan, with a market potential exceeding $1.5 billion per year, but envisions further development only in collaboration with a partner.
Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has demonstrated anti-inflammatory therapeutic effects in pre-clinical disease models and human studies. In vitro experiments showed that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), unlike the marketed C5aR inhibitor. It has also shown a favorable reactive metabolite profile in human liver microsomes.
Data from a first-in-human study indicated that izicopan was well-tolerated and showed no safety signals of concern in single doses (3 mg to 240 mg) or multiple doses (30 mg once per day to 90 mg twice per day for 14 days). Pharmacokinetic/pharmacodynamic data suggest izicopan’s potential, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern.
In patients with HS, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses, and reductions in patient-reported pain scores. In chronic spontaneous urticaria, InflaRx observed reductions in the 7-day Urticaria Activity Score (UAS7) and improved disease control.
InflaRx is a biopharmaceutical company focused on anti-inflammatory therapeutics targeting the complement system. Its lead program is izicopan. The company has also developed vilobelimab, an anti-C5a monoclonal antibody.
InflaRx was founded in 2007 and has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA.
Source: InflaRx N.V.
