MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg Ulcers

Core Viewpoint - MediWound Ltd. has initiated a pivotal Phase III trial named VALUE to evaluate the efficacy and safety of EscharEx for treating venous leg ulcers (VLUs), aiming to redefine the standard of care in chronic wound debridement [1][2][10] Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development and commercialization of innovative biologics [9] - The company’s first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in burns, significantly reducing the need for surgical interventions [10] Clinical Trial Details - The VALUE study is a global, multicenter, randomized, double-blind, placebo-controlled trial involving 216 patients across 40 sites in the U.S. and Europe [2][3] - Patients will be randomized 1:1 to receive either EscharEx or placebo, with up to eight daily applications over two weeks, followed by ten weeks of standardized wound management [2] - The primary endpoints include the incidence of complete debridement and complete wound closure, with secondary endpoints assessing granulation tissue, time to debridement, and changes in wound area [3] Strategic Collaborations - To support the VALUE trial, MediWound has established strategic research collaborations with industry leaders Solventum, Mölnlycke, and MIMEDX to ensure consistent wound management across study sites [4] Future Studies - In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025 comparing EscharEx to collagenase in VLU patients [5] - The company is also preparing for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), expected to begin in 2026 [5] Market Context - Venous leg ulcers affect approximately 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S., highlighting the urgent need for effective treatment options [6] - The current market leader in wound debridement, SANTYL, has a market size exceeding $375 million, indicating significant potential for EscharEx to capture market share [2][10]