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InflaRx Announces Positive Data from Third Cohort of Phase IIa Open-Label Study with Vilobelimab in Pyoderma Gangraenosum
6 out of 7 patients (85.7%) showed clinical remission (PGA score ≤ 1) and closure of target ulcer in the highest dose cohortTreatment was well tolerated; no
About this update from Inflarx N.v.
[{"type":"text","content":"6 out of 7 patients (85.7%) showed clinical remission (PGA score ≤ 1) and closure of target ulcer in the highest dose cohortTreatment was well tolerated; no dose-related adverse events observedFinal post treatment observational data will be available in the first half of 2022InflaRx to host conference call today at 8:30 am EDT / 2:30 pm CEST JENA, Germany, Oct. 27, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG). “We are happy to see more patients responding with the highest dose of vilobelimab in patients with Pyoderma Gangraenosum,” commented Dr. Korinna Pilz, Chief Clinical Development Officer of InflaRx. “There is a need for better treatment options for this painful and debilitating condition. With the good safety profile and promising efficacy results we have seen in this trial, we will seek FDA guidance on next steps towards a pivotal program.” As previously announced, a total of 19 patients were enrolled in the multi-center, proof-of-concept study, with seven patients enrolled in the third cohort. 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. Following the treatment period, patients continued to be observed for a period of two months, which is ongoing for the third cohort. Per protocol, a dose increase to the next higher dosing group was possible upon disease assessment on day 57, if at least five patients in the cohort had been treated without safety concerns and the patient was assessed with a Physician Global Assessment (PGA) score of 4 or higher. The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG. Efficacy is being evaluated by a responder rate defined as a PGA score of ≤3 of the target ulcer at various timepoints and time to complete closure (remission) of the target ulcer. In the third dosing cohort at 2400mg biweekly, all seven patients were evaluated at least on the day of last drug administration. Six of the seven patients achieved clinical remission wi...