11 January 2018 - - The US Food and Drug Administration has accepted Jena, Germany-based biopharmaceutical company InflaRx N.V.'s (NASDAQ: IFRX) investigational new drug (IND) application, the company said.
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 (HS), a painful, chronic, and debilitating inflammatory skin disease.
This randomised, 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.
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.
IFX-1 completely blocks biological activity in and demonstrates high selectivity towards its target, C5a in human blood, thus leaving the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism.
IFX-1 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.
InflaRx is focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx has offices in Jena and Munich, Germany.