MediWound's EscharEx Phase III VALUE Study To Continue Without Modification Following DSMB Review
(RTTNews) - MediWound Ltd. (MDWD) announced that an independent Data and Safety Monitoring Board (DSMB) completed its pre-specified periodic safety review of the ongoing Phase III VALUE study evaluating EscharEx in patients with venous leg ulcers (VLU) and recommended that the trial continue as planned without modification.
The DSMB did not identify any safety concerns during the review, supporting the continued evaluation of EscharEx's safety and efficacy in chronic venous leg ulcers.
MediWound also expects the study's pre-specified interim sample-size reassessment and completion of patient enrollment by the end of the first quarter of 2027.
Ofer Gonen, Chief Executive Officer of MediWound, said the DSMB recommendation was encouraging and consistent with the favorable safety profile observed across the EscharEx clinical program, supporting 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 evaluating the efficacy and safety of EscharEx in patients with venous leg ulcers.
The study is designed to enroll 216 patients across approximately 40 sites in the U.S., Europe and Israel, randomized 1:1 to receive EscharEx or placebo.
The co-primary endpoints are the incidence of complete debridement and facilitation of wound closure.
A pre-specified interim sample-size reassessment is planned after 65% of patients complete the 12-week wound-management period, with the reassessment and enrollment completion expected by the end of the first quarter of 2027.
EscharEx is a bromelain-based bioactive enzymatic therapy in advanced clinical development for debridement of chronic and hard-to-heal wounds.
The investigational therapy is designed for topical, once-daily use and has demonstrated wound bed preparation and a favorable safety profile in Phase II studies.
MDWD has traded between $12.52 and $20.03 over the past year. The stock closed Friday's trading (September 11, 2026) at $13.11, down 4.38%. In pre-market trading the stock is at $13.40, up 2.21%.
