InflaRx N.V. (NASDAQ: IFRZX) Receives Corrected Advice Letter From The FDA on Phase III Study of Vilobelimab in Hidradenitis Supprativa

InflaRx N.V. (NASDAQ: IFRZX) has announced that the US FDA has granted it a corrected advice letter related to the third phase program with vilobelimab for hidradenitis suppurative treatment.

FDA recommended the use of Hidradenitis Suppurativa Clinical Response Score

The Food and Drug Administration doesn’t recommend that InflRx should use the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary outcome for the selected patient group in this corrected letter but instead makes recommendations regarding the implementation of the modified HiSCR (m-HiSCR). The written guidance letter received in February 2022 asserted that the Agency FDA recommended the use of the HiSCR as the primary outcome in the Phase 3 trial, which contradicted the Type A meeting minutes’ advice held in the third quarter of 2021 between InflaRx and the FDA.

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

InflaRx feels that further advancement in HS is viable following the FDA’s revised advice. Considering the additional funding requirements for a full third  Phase HS program and recent positive data in another immuno-dermatological disorder, pyoderma gangrenosum, the Company is currently evaluating potential alternatives for developing vilobelimab in this disease segment.

In Q2 2022, the Company intends to provide an update to the marketplaces on its pipeline development strategy.

Vilobelimab first monoclonal anti-C5a antibody in clinical trials 

Vilobelimab is a  monoclonal anti-human supplement factor C5a antibody that inhibits C5a’s bioactivity while also demonstrating good selectivity in blood. Therefore unlike molecules that inhibit C5 cleavage, vilobelimab preserves the establishment of the membrane invasion complex (C5b-9) as an essential defense mechanism. In preclinical studies, vilobelimab was shown to control the inflammatory reaction-driven tissue or organ destruction by specifically obstructing C5a, a key “amplifier” of this reaction.

Vilobelimab is thought to be the maiden first-in-class monoclonal anti-C5a antibody to enter clinical trials. In finished clinical trials, more than 300 people were treated with vilobelimab, and the antibody was found to be well tolerated.