MediWound announced the initiation of a phase 3 trial evaluating EscharEx for venous leg ulcers. The randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of EscharEx in enzymatic debridement of chronic wounds.

EscharEx has demonstrated effective removal of necrotic tissue in multiple phase 2 trials. “With no new FDA–approved drugs in this category since 1965, EscharEx has the potential to redefine the standard of care for chronic wound debridement,” said Ofer Gonen, CEO of MediWound.

Venous leg ulcers (VLUs) affect approximately 2% of patients aged 65 years and older, with more than 1.5 million new cases annually in the U.S. These ulcers, resulting from chronic venous insufficiency, can lead to severe pain, infection, and disability.

The trial will enroll 216 patients at 40 sites in the U.S. and Europe. Participants will receive up to eight daily applications of EscharEx over two weeks, followed by 10 weeks of standard wound care. Interim results are expected by mid-2026, after 65% of patients complete treatment.

MediWound has partnered with Solventum, Mölnlycke, and MIMEDX to ensure consistent wound management across study sites. A phase 2 study comparing EscharEx with collagenase in VLUs is planned for 2025, and a phase 2/3 trial for diabetic foot ulcers is expected to begin in 2026.