MediWound has launched VALUE, a pivotal Phase III trial for EscharEx®, its enzymatic treatment for venous leg ulcers (VLUs). The global, double-blind, placebo-controlled trial will assess EscharEx’s efficacy in debridement and wound closure in 216 patients across the U.S. and Europe, with an interim analysis expected in mid-2026. The company has partnered with Solventum, Mölnlycke, and MIMEDX for wound management products and support.
This trial is crucial because it addresses a significant unmet need in VLU treatment. No new FDA-approved VLU drug has entered the market since 1965, leaving a substantial opening for a more effective debridement therapy. EscharEx’s potential to improve debridement and wound closure could significantly impact patient outcomes, reducing pain, infection risk, and disability associated with VLUs. This advancement could also streamline treatment pathways and potentially lower healthcare costs by accelerating healing and minimizing the need for complex interventions.
The VALUE trial employs a 1:1 randomization of EscharEx versus placebo, with treatment involving up to eight daily applications over two weeks. Following treatment, patients will undergo ten weeks of standard wound management. Those achieving wound bed preparation will then receive a cellular/tissue-based product or an autograft, with an additional 12 weeks of monitoring for those who achieve complete closure. The trial’s co-primary endpoints are the incidence of complete debridement and complete wound closure. Beyond VALUE, MediWound plans a head-to-head Phase II trial comparing EscharEx to collagenase in VLU patients, and a Phase II/III trial for diabetic foot ulcers, further solidifying its commitment to advanced wound care solutions.
Positive results from the VALUE trial could position EscharEx as a leading treatment for VLUs, significantly expanding MediWound’s market presence within the estimated $375+ million wound debridement market. This success would validate the company’s enzymatic platform and potentially pave the way for broader applications in other chronic wound types, ultimately reshaping the landscape of wound care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
