Business
MediWound Completes Enrollment of its EscharEx U.S. Phase 2 Adaptive Design Study
Topline Data Expected in the First Quarter of 2022 YAVNE, Israel, Dec. 06, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a
About this update from Mediwound Ltd.
[{"type":"text","content":"Topline Data Expected in the First Quarter of 2022\nYAVNE, Israel, Dec. 06, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced it has completed patient enrollment in its U.S. Phase 2 adaptive design clinical study evaluating the safety and efficacy of EscharEx® in debridement of venous leg ulcers (VLUs) compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement). In July 2021, the Company reported a positive outcome from its planned interim assessment on sample-size re-estimation for this study, conducted after 80 patients were treated, with no changes to the original study sample size of 120 patients and no safety concerns identified. Topline data from clinical study is now anticipated in the first quarter of 2022. “Completing enrollment in our U.S. phase 2 trial is an important step in advancing EscharEx as a non-surgical rapid and effective debridement agent with the potential to improve on the current standard of care for chronic wound management,” said Sharon Malka, Chief Executive Officer of MediWound. “Chronic wound care is a significant market opportunity for us with an addressable market of over one billion dollars annually, and we believe EscharEx could be a meaningful part of that market. We look forward to sharing topline data from this study in the first quarter of 2022.” Dr. Robert Snyder, Chief Medical Director of EscharEx program added, “We are pleased to see EscharEx move forward in its development as a potential therapy for people suffering from chronic wounds. We thank our partners, the investigative staff, and especially the patients and families for their commitment and perseverance in completing enrollment in the face of all the challenges posed by the pandemic.” The study is a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs. The study enrolled 120 patients at approximately 20 clinical sites, primarily in the U.S. Study participants were randomized to either EscharEx, placebo control or non-surgical standard-of-care of either enzymatic or autolytic debridement, at a ratio of 3:3:2...