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MediWound Announces Positive Topline Results From Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds
Primary Endpoint Met with Highly Statistically Significant ResultsNo Observed Safety IssuesFinal Data Readout Expected in Second Quarter of 2022 YAVNE,
About this update from Mediwound Ltd.
[{"type":"text","content":"Primary Endpoint Met with Highly Statistically Significant ResultsNo Observed Safety IssuesFinal Data Readout Expected in Second Quarter of 2022 YAVNE, Israel, Jan. 24, 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 topline 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, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel vehicle, with a p-value of 0.004. The study randomized 120 patients, of which 119 patients were treated by either EscharEx (n=46), a gel vehicle (n=43), or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement (n=30). The study met its primary endpoint with high degree of statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to patients treated with gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). After adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size and age, regions, and sites, EscharEx efficacy superiority remained statistically significant compared to gel vehicle. Incidence of complete debridement of the non-surgical standard-of-care arm, during the same 14-day measurement period, was 13% (4/30). In addition, the Independent Data Monitoring Committee reviewed the data of all patients treated and no safety concerns were identified in the study population. EscharEx was well-tolerated and overall safety was comparable between the arms. No differences were found in reported adverse events and no serious adverse event was related to study treatment. Patient baseline characteristics were comparable across all study arms. “We are excited to report these robust topline results from our U.S. Phase 2 clinical study, which corroborate the results of our prior Phase 2 study. The primary endpoint efficacy data are highly encouraging and further reinforce our belief that EscharEx has the potential to become a best-in-class non-surgic...