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MediWound Announces Last Patient Out in EscharEx U.S. Phase 2 Trial for the Debridement of Chronic Wounds
Primary Endpoint Met with Highly Statistically Significant ResultsFinal Data Readout Expected in Second Quarter of 2022 YAVNE, Israel, March 21, 2022 (GLOBE
About this update from Mediwound Ltd.
[{"type":"text","content":"Primary Endpoint Met with Highly Statistically Significant ResultsFinal Data Readout Expected in Second Quarter of 2022 YAVNE, Israel, March 21, 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 that the last patient in its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs) has completed the study treatment visits as well as the required follow up. As previously announced on January 24, 2022, 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). Final data set readout, including secondary and exploratory endpoints as well as additional safety measurements, which will allow further evaluation of clinical benefits, is expected in the second quarter of 2022. “We are pleased to announce the completion of patient treatment and follow-up in this Phase 2 study, which represents another important milestone for MediWound and our EscharEx clinical program,\" said Sharon Malka, Chief Executive Officer of MediWound. \"Given the recent primary efficacy data from this study and from prior studies, which showed complete debridement in a matter of days, we believe EschaEx has the potential to become a best-in-class debridement option for millions of patients suffering from hard-to-heal wounds and is well-positioned to be meaningful part of chronic wound debridement market. We look forward to reviewing the full data set in the coming months with the goal of advancing this exciting program into pivotal Phase 3 clinical trials. We are very grateful to the clinical investigators, trial participants and their families for their time and commitment.\" Study Design The study is a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs compared to gel vehicle (placebo control) and non-surgical standard-of-care of either enzymatic or autolytic debridement. The study randomized 120 p...