Press release
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inflaRx InflaRx Announces Positive Data from Third Cohort of Phase lla 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 cohort Treatment was well tolerated ; no dose - related adverse events observed Final post treatment observational data will be available in the first half of 2022 InflaRx to host conference call today at 8:30 am EDT / 2:30 pm CEST - Jena , Germany , October 27 , 2021 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 lla 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 with a PGA score of ≤1 , which reflects a closure of the target ulcer . All patients in cohort 3 had