MediWound Ltd. announced on February 12, 2025, the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). This study is designed as a multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design.
The VALUE study will enroll 216 patients across 40 sites in the U.S. and Europe, with the primary objective of assessing EscharEx's efficacy and safety in achieving effective debridement and preparing the wound bed for healing. An interim sample size assessment is planned for mid-2026 after 65% of patients complete treatment.
MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX to ensure consistent wound management across study sites. The company also plans to initiate a head-to-head Phase II study against collagenase in 2025 and is preparing for a Phase II/III trial for diabetic foot ulcers (DFUs) in 2026.
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