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US FDA accepts InflaRx's IND, company to begin phase IIb trial with IFX-1 in Hidradenitis Suppurativa

Jena, Germany
Thursday, January 11, 2018, 14:30 Hrs  [IST]

InflaRx N.V, the biopharmaceutical company developing new therapeutics in the terminal complement space, announced the acceptance of their Investigational New Drug (IND) application by the US Food and Drug Administration (FDA). The open IND will allow InflaRx to conduct a phase IIb study to determine efficacy and safety of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with moderate or severe Hidradenitis Suppurativa. The randomized, double-blind and placebo-controlled multicenter study is planned to be conducted at approximately 50 sites in several countries and expected to enroll approximately 175 patients, divided equally into five cohorts. InflaRx intends to initiate the study in the first quarter of 2018.

Hidradenitis Suppurativa (HS) is a painful, chronic and debilitating inflammatory skin disease. The study's primary goal is to evaluate the dose-response signal of IFX-1 in patients with HS according to the Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16 during the study period. Secondary goals are assessment of further efficacy and patient-reported outcome parameters, as well as the safety and tolerability of IFX-1. After the placebo-controlled double-blind phase, the study will be extended into an open label extension phase to assess long-term efficacy and safety. The study will be coordinated by the principal investigator Prof. Dr. med. Evangelos J. Giamarellos-Bourboulis at the ATTIKON University Hospital in Athens, Greece.

Othmar Zenker, M.D., chief medical officer of InflaRx, said: "With the experience gained from an earlier study of IFX-1 in patients with Hidradenitis Suppurativa, which demonstrated good safety and encouraging efficacy signals, this trial is designed to find the optimal dose range as well as to assess long term efficacy and safety of IFX-1. C5a blockade with IFX-1 offers an entirely new mode of action to treat this disease in which the terminal complement system is highly activated. This study will help us evaluate a potential new way to treat Hidradenitis Suppurativa."

IFX-1 is a first-in-class monoclonal anti-complement factor C5a antibody which completely blocks biological activity in and demonstrates high selectivity towards its target, C5a 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 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 people have so far been treated with IFX-1 which was well tolerated. IFX-1 is currently being developed for different inflammatory indications.


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