DSMB Clears MediWound’s Phase III EscharEx Trial to Proceed Unchanged After Safety Review

MediWound Ltd. (MDWD) disclosed that an independent Data and Safety Monitoring Board (DSMB) has finished its scheduled safety review of the ongoing Phase III VALUE study of EscharEx in venous leg ulcer (VLU) patients and recommended the trial continue without any changes.

No safety signals were flagged by the DSMB, reinforcing the continued assessment of EscharEx’s safety and efficacy in chronic venous leg ulcers.

MediWound also anticipates completing its pre-specified interim sample-size reassessment and full patient enrollment by the end of Q1 2027.

CEO Ofer Gonen described the DSMB’s recommendation as encouraging and in line with the favorable safety profile seen throughout the EscharEx clinical program, supporting the continued execution of the pivotal Phase III study.

About the VALUE Phase III Trial

VALUE (NCT06568627) is a global, multicenter, randomized, double-blind, placebo-controlled Phase III trial assessing EscharEx’s efficacy and safety in venous leg ulcer patients.

The trial aims to enroll 216 patients across roughly 40 sites in the U.S., Europe, and Israel, randomized 1:1 to EscharEx or placebo.

The co-primary endpoints are complete debridement incidence and wound closure facilitation.

A pre-specified interim sample-size reassessment is planned once 65% of patients complete the 12-week wound-management period, with both the reassessment and enrollment completion expected by the end of Q1 2027.

EscharEx is a bromelain-based bioactive enzymatic therapy in advanced development for debridement of chronic and hard-to-heal wounds. The investigational product is designed for topical, once-daily application and has shown wound bed preparation benefits and a favorable safety profile in Phase II studies.

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