On March 17, 2022 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported that the Company has received a corrected advice letter from the U.S. Food and Drug Administration (FDA) related to its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS) (Press release, InflaRx, MAR 17, 2022, View Source [SID1234610261]). In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score ("HiSCR") as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR (m-HiSCR).1 The written advice letter received in February 2022 had stated that the Agency recommended using the HiSCR as the primary endpoint in the Phase III trial, which was inconsistent with the minutes from a Type A advice meeting held between InflaRx and the FDA in the third quarter of 2021.

"We appreciate the prompt feedback from the FDA clarifying the advice received in February," stated Dr. Korinna Pilz, Chief Clinical Development Officer.

In light of this corrected advice from FDA, InflaRx believes that further development in HS is feasible. Given the additional financing needs for a full Phase III HS program and the recent promising data in another immuno-dermatological disease, pyoderma gangrenosum, InflaRx is currently evaluating its strategic options on how to most efficiently develop vilobelimab in this disease space.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1 m-HiSCR is defined as achieving both i) total body inflammatory lesion count (ANdT) reduction from Baseline of at least 50% and ii) a draining tunnel (dT) count reduction from Baseline of at least 50% at the end of Week 16.

The Company plans to update the markets on its pipeline development strategy in the second quarter of 2022.

About Vilobelimab

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab 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. Vilobelimab has been demonstrated in pre-clinical studies to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, and has recently reported positive Phase II results in ANCA-associated vasculitis and Phase IIa results in pyoderma gangrenosum. Vilobelimab is in Phase III development for the treatment of critically ill COVID-19 patients and in Phase II development for patients suffering from cutaneous squamous cell carcinoma (cSCC).