(NASDAQ: IFRX) InflaxRx N.V. shares are up more than 11% in pre-market trading on more than 3200 trades and increasing volume. Shares are $1.58 and volume is increasing on FDA news.

• US Food and Drug Administration awards Fast Track designation for the treatment of ulcerative pyoderma gangrenosum
• Fast track follows recently reported orphan drug designation by both US FDA and EMA

JENA, Germany, July 06, 2022 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq:IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the US Food and Drug Administration (FDA) granted a Fast Track designation to the development of its first-in-class anti-C5a monoclonal antibody vilobelimab for the treatment of ulcerative pyoderma gangrenosum (PG). The Company had submitted a request for Fast Track designation to the FDA on the positive outcome data in PG from its Phase IIa open-label dose-escalation study.

As previously announced, in the multi-center, proof-of-concept Phase IIa study a total of 19 patients were enrolled. Over a treatment period of 26 weeks, patients were treated biweekly with vilobelimab 800mg, 1600mg or 2400mg, after an initial run-in phase with three doses of 800mg on days 1, 4 and 8, followed by a two-month observation period. Efficacy was assessed with the physician global assessment score (PGA), and 6 out of 7 patients (85.7%) in the high dose cohort demonstrated complete target ulcer closure and treatment response correlated with suppression of C5a levels in patients’ plasma over time.

The Company had previously announced that vilobelimab was granted orphan drug designation for the treatment of PG by both the FDA in the US and the European Medicines Agency (EMA) in Europe and that the Company had held a productive End-of-Phase II meeting with the Division of Dermatology with the FDA related to its Phase III development plans in PG.

“We are pleased that our development in pyoderma gangrenosum has been designated Fast Track by the FDA shortly after receiving the Orphan Drug designation, recognizing PG as serious condition with high unmet medical need and vilobelimab as promising potential future treatment option,” said Prof. Niels C. Riedemann, CEO and Founder of InflaRx. “The Fast Track designation will further facilitate our interactions with the FDA related to our development in PG and will also allow for faster review and approval upon successful completion of a Phase III development program,” he added.