MediWound Ltd. (NASDAQ: MDWD) announced that an independent Data and Safety Monitoring Board (DSMB) completed a pre-specified periodic safety review of its ongoing Phase III VALUE study and recommended the trial continue without modification.

The DSMB did not identify any safety concerns during its review of the study, which is evaluating the safety and efficacy of EscharEx in patients with venous leg ulcers (VLU).

MediWound said it continues to expect 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 in a statement: "The DSMB's findings are consistent with the favorable safety profile observed across the EscharEx clinical program and support our continued execution of this pivotal Phase III study."

The VALUE trial (NCT06568627) is a global, multicenter, randomized, double-blind, placebo-controlled study designed to enroll 216 patients across approximately 40 sites in the U.S., Europe, and Israel. Patients are randomized in a 1:1 ratio to receive EscharEx or placebo. The co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure.

The study includes a pre-specified interim sample-size reassessment after 65% of patients have completed the 12-week wound-management period. The DSMB conducts its periodic reviews to address safety only, separately from the interim efficacy assessment.

EscharEx is a bromelain-based enzymatic therapy in clinical development for the debridement of chronic wounds. MediWound's FDA-approved product NexoBrid is indicated for eschar removal in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets.