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InflaRx Reports Third Quarter 2021 Financial & Operating Results
Feedback received from FDA supportive of new primary endpoint measuring reductions in all three inflammatory Hidradenitis Suppurativa (HS) lesions for Phase
About this update from Inflarx N.v.
[{"type":"text","content":"Feedback received from FDA supportive of new primary endpoint measuring reductions in all three inflammatory Hidradenitis Suppurativa (HS) lesions for Phase III program with vilobelimab in HSIn Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum, 6 out of 7 patients in highest dose cohort showed clinical remission and closure of target ulcerInflaRx awarded grant by German government of up to €43.7 million to advance development of vilobelimab for treatment of severe COVID-19 patientsEnrollment completed in Phase III part of Phase II/III study evaluating vilobelimab in severe COVID-19; Topline results expected in Q1 2022Cash, cash equivalents and financial assets of approximately €120.6 million as of September 30, 2021 JENA, Germany, Nov. 05, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and nine months ended September 30, 2021. “We are pleased by the recent developments with our immunodermatology franchise with vilobelimab, including the outcome of the Type A meeting with the FDA for Hidradenitis Suppurativa and positive results in our study in Pyoderma Gangraenosum,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Before year end, we expect additional important catalysts for the Company, including data from our Phase II AAV study. We also are grateful for the grant from the German government to assist in advancing our COVID-19 program, from which topline data are expected in Q1 2022.\" Recent Corporate Highlights and R&D Update Vilobelimab in Hidradenitis Suppurativa (HS) In September, InflaRx announced the outcome of its Type A meeting with the U.S. Food & Drug Administration (FDA). The FDA response was supportive of a pivotal study program that focuses on patients with active draining tunnels and a new primary efficacy endpoint that will include measuring the reduction of all three lesions - inflammatory nodules, abscesses and draining tunnels. The Company also plans to include various secondary and exploratory endpoints to validate the new primary efficacy measure, which thus far has not been used in prospective, randomized trials. InflaRx is still in active dialogue with the FDA on the final d...