This follows the the U.S. Food and Drug Administration’s approval of the company’s investigational new drug application (IND).
The Phase 2 trial is expected to recruit approximately 36 patients at roughly 20 sites in the U.S. It will mainly evaluate the safety and effectiveness of two different dose regimens of IFX-1 compared with placebo in patients also receiving the current standard of care.
IFX-1 is a first-in-class antibody that targets the complement factor C5a. Complement C5a is a protein of the complement system, a part of the immune system that normally fights infections. It plays a role in the progression of a wide variety of autoimmune and other inflammatory diseases when the body’s regulation of its activity is abnormal.
C5a is thought to amplify the harmful immune response that is characteristic of AAV, playing a key role in vessel inflammation. IFX-1 is designed to neutralize the effects of C5a without affecting the normal immune response to infections.
InflaRx reported that IFX-1 was well-tolerated by more than 150 people who participated in three Phase 2 clinical trials involving different inflammatory conditions, including hidradenitis suppurativa. It also demonstrated a unique C5a selectivity and blocking ability.
“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 or severe Hidradenitis Suppurativa (HS) earlier this year,” Othmar Zenker, MD, chief medical officer of InflaRx, said in a press release.
“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,” he said.
InflaRx is a biopharmaceutical company that develops innovative therapeutics to treat inflammatory diseases by targeting the complement system.