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MediWound Announces Positive Results from Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds
Study Met Primary and Key Secondary Endpoints with Statistically Significant Results Compared to Control Arms Significant Improvement Across Multiple Measures
About this update from Mediwound Ltd.
[{"type":"text","content":"Study Met Primary and Key Secondary Endpoints with Statistically Significant Results Compared to Control Arms Significant Improvement Across Multiple Measures Over the Current Non-Surgical Standard-of Care No Deleterious Effect on Wound Closure and No Observed Safety Issues End of Phase 2 Meeting with FDA Targeted for Second Half 2022 YAVNE, Israel, May 12, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, its key secondary endpoints with high degree of statistical significance, as well as its wound closure safety measurements. MediWound anticipates meeting with the U.S. Food and Drug Administration (the “FDA”) in the second half of 2022, for an End-of-Phase 2 meeting to discuss study results and a potential Phase 3 pivotal plan for EscharEx. U.S. key opinion leaders will join MediWound management in its coming earning call on May 17 at 8:30am EDT to discuss the data. The study met its primary endpoint with a high degree of statistical significance, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). EscharEx efficacy superiority remained statistically significant compared to gel vehicle after adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size, wound age and regions. The study met key secondary and exploratory endpoints. Patients treated with EscharEx had a statistically significant higher incidence of complete debridement, during the same 14-day measurement period, compared to patients treated by non-surgical standard-of-care (\"NSSOC\") (EscharEx: 63% (29/46) vs. NSSOC: 13% (4/30)) and the time to achieve complete debridement was significantly shorter. Estimated median time to complete debridement, was 9 days for patients treated with EscharEx and 59 days for patients treated with NSSOC (p-value=0.016). On average, complete debridement was achieved after 3....