InflaRx N.V., a biopharmaceutical company developing innovative therapeutics to treat life-threatening inflammatory diseases by targeting the complement system, a key component of the innate immune system, announced the approval of their Investigational New Drug (IND) application by the US Food and Drug Administration. The open IND will allow InflaRx to start their planned phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA associated vasculitis (AAV).

AAV is a rare and life-threatening autoimmune disease in which activation of the complement system, and specifically generation of C5a, is believed to play a key role in the neutrophil-driven vessel inflammation that defines the disease. AAV affects approximately 40,000 and 75,000 patients in the United States and Europe, respectively.

Othmar Zenker, MD, Chief Medical Officer of InflaRx, said: “US FDA IND approval marks another important milestone for InflaRx, allowing us to conduct parallel clinical development of IFX-1 in two indications, following the successful launch of the SHINE study in patients with moderate and severe Hidradenitis Suppurativa (HS) earlier this year. A growing body of research suggests C5a may play a critical role in amplifying inflammatory responses in AAV. IFX-1 has been shown to effectively control C5a activation in several clinical phase II studies to date and our team is eager to study the potential clinical benefit this antibody candidate could bring to patients suffering from this life-threatening disease.”

The phase II study will enroll approximately 36 patients in approximately 20 sites in the US. The main objective of the study is to evaluate the safety and efficacy of two different dose regimens of IFX-1 in comparison with placebo on top of current standard of care.

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.