Announcement • May 08
InflaRx N.V. Advances Izicopan in ANCA-Associated Vasculitis and Select Renal Diseases
InflaRx N.V. intended to develop izicopan in ANCA-associated vasculitis (AAV), with a secondary goal of establishing rapid proof of concept in additional life-threatening renal diseases. InflaRx is conducting Phase 2 planning for izicopan in AAV and is evaluating the feasibility of multiple development approaches, including the potential for an expedited path to the commercial market, in an effort to best address the evolving regulatory environment surrounding the currently approved comparator, avacopan. In addition, the Company has announced its goal of establishing rapid proof of concept for izicopan across a broader range of complement-mediated life-threatening kidney diseases by conducting open-label studies that are expected to begin generating clinical data next year in certain indications. These additional renal disease targets include atypical hemolytic uremic syndrome (aHUS), IgA nephropathy (IgAN) and C3 glomerulopathy (C3G), where early evidence already exists for the role of C5a/C5aR inhibition and where izicopan’s favorable clinical profile could be a significant differentiator. Toward these efforts, InflaRx anticipates conducting a pharmacokinetic bridging study in China this year. InflaRx estimates it will have sufficient funds to execute currently planned development programs through meaningful milestones, including proof-of-concept data readouts in aHUS, IgAN and C3G, the Phase 2 data readout in AAV, as well as ongoing operations, through 2029. InflaRx expects to host a Capital Markets Day to further detail the potential of izicopan’s best-in-class properties in AAV, aHUS, IgAN and C3G this summer. InflaRx will host a webcast/conference call on Friday, May 8, at 8:30 AM ET /2:30 PM CET. Izicopan for hidradenitis suppurativa (HS) InflaRx has largely concluded its interactions with FDA regarding an optimized clinical development program for izicopan in HS, and believes a viable path forward exists. The Company believes HS remains a significant opportunity for izicopan, with a market potential that could exceed $1,500 million per year, with further development currently envisioned only in collaboration with a partner. Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), which plays an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Izicopan has also demonstrated a favorable reactive metabolite profile in human liver microsomes. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic /pharmacodynamic data support the best-in-class potential of izicopan, with a =90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). In addition, InflaRx has begun planning for development of izicopan in AAV and additional renal indications.
