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InflaRx Reports Full Year 2022 Financial and Operating Results
Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug
About this update from Inflarx N.v.
[{"type":"text","content":" Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol submitted; first patient expected around mid-2023Fast Track and Orphan Drug designations granted for treatment of pyoderma gangrenosum (PG) in the United States and Orphan Drug designation granted in Europe Encouraging results from Phase III study in critically ill COVID-19 patients published in The Lancet Respiratory MedicineEmergency Use Authorization (EUA) application for treatment of critically ill, invasively mechanically ventilated COVID-19 patients submitted to the FDA; review ongoing First-in-human clinical trial with oral C5aR inhibitor INF904 initiated in November 2022; first data expected in H2 2023Amendment of co-development agreement with Staidson and incremental $2.5 million equity investment by Staidson HK for planned regulatory filing of BDB-001 for COVID-19 in ChinaTotal funds available approximately €83.7 million as of December 31, 2022, funding the company into H2 2025 JENA, Germany, March 22, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced financial and operating results for the year ended December 31, 2022. Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: “We are very pleased with the exceptional progress we have made in the past year with our lead drug candidate, vilobelimab, in several areas, as well as in advancing our pipeline with a new clinical asset, INF904, an orally available small molecule inhibitor of the C5a receptor. Upon detailed feedback from the FDA related to our development of vilobelimab for the treatment of PG, a rare debilitating and neutrophil driven skin disease, we have designed and submitted a Phase III protocol to the FDA while we are currently initiating the trial. We also submitted an EUA application to treat critically ill, mechanically ventilated patients with COVID-19, who today are still facing poor outcomes, and shortly await a decision from the FDA. Further, we expect first results from our ongoing Phase I clinical trial with INF904 and interim results from our Phase II clinical trial in cutaneous squamous cell carcinoma l...