InflaRx N.V. (IFRX) reports that it has treated its first patient in a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1 in Pyoderma Gangraenosum (PG).
A rare and debilitating neutrophilic-driven autoinflammatory disease, characterized by an acute, destructive ulcerating process of the skin, primarily occurring on the legs. The exact prevalence of PG is not yet known, but it is estimated that up to 50,000 patients in the US and Europe are impacted by the disease.
This open-label Phase IIa proof-of-concept study is planning to enroll approximately 12 patients with moderate to severe PG. The study is anticipated to initially be conducted at three sites in Canada, Patients will be treated with IFX-1 for 12 weeks with a three-month follow up period. The main objectives of the study are the evaluation of the safety and efficacy of IFX-1 in patients with PG. Efficacy will be evaluated by a responder rate defined as Physician Global Assessment less than three of the target ulcers at various timepoints and time to complete closure of the target ulcer. Both endpoints will be compared with historical data. Additional clinical endpoints include a photographic documentation and analysis of the ulcer size and several patient-reported outcome parameters, such as pain score and Dermatology Life Quality Index (DLQI).
IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.
Afsaneh Alavi, MD, Assistant Professor of Dermatology, University of Toronto