InflaRx N.V., a biopharmaceutical company developing new therapeutics in the terminal complement space, announced enrollment of the first patient in its phase IIb study with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe hidradenitis suppurativa (HS). HS is a painful, chronic and debilitating inflammatory skin disease with limited treatment options.
The randomized, double-blind, placebo-controlled, multicenter study will be conducted in approximately 50 sites in several countries, including the United States, Germany, Greece, Denmark and the Netherlands. Approximately 175 patients will be enrolled in five dose groups. After a placebo-controlled, double-blind period of 16 weeks, the study will be extended to a 28-week open-label extension phase to assess long-term efficacy and safety. The main objective of the study is the evaluation of a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16 as the primary endpoint. Additional objectives include the evaluation of safety and tolerability of IFX-1 as well as an assessment of additional efficacy and patient-reported outcome parameters.
Othmar Zenker, M.D., chief medical officer of InflaRx, said: "We are very pleased to start our first phase IIb trial with our lead candidate IFX-1. After the very promising results from a phase IIa trial, with this study we aim to determine the optimal dose regimen as well as to assess the long-term efficacy and safety of IFX-1."
Prof. Dr. med. Evangelos J. Giamarellos-Bourboulis, of the ATTIKON University Hospital in Athens, Greece, the principal investigator of this trial, said: "New treatment options for moderate to severe HS are of immense importance to patients and clinicians as the current treatment options for many patients with HS are limited. The C5a blockade with IFX-1 offers an entirely new mode of action to tackle this disease. The trial design is based on the exciting results from the previously conducted phase IIa study."
IFX-1 is a first-in-class monoclonal anti-complement factor C5a antibody which highly 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 demonstrated control of 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 the first monoclonal anti-C5a antibody introduced into clinical development and has, to date, successfully completed three clinical phase II studies. In total, over 150 patients have so far been treated with IFX-1, which was well tolerated. IFX-1 is currently being developed for different inflammatory indications.