MediWound has commenced a pivotal, multicentre Phase III VALUE trial to assess its bioactive debridement therapy, EscharEx, for treating venous leg ulcers (VLUs).
The primary aim of the trial is to determine the therapy’s safety and efficacy in achieving debridement and preparing the wound bed for VLUs healing.
With an adaptive design, the global, double-blind, prospective, randomised, placebo-controlled trial is set to take place across 40 European and US sites.
It will enrol 216 subjects who will be randomised into 1:1 ratio to receive either the therapy or a placebo.
The treatment involves up to eight daily applications over a two-week period, with ten weeks of standardised wound care treatment to be followed.
Throughout the trial, EscharEx’s tolerability and safety will be evaluated.
Subjects who achieve wound bed preparation will then be treated with a cellular/tissue-based product or an autograft.
Those with complete wound closure will be monitored for 12 weeks more.
Co-primary endpoints of the trial are the incidence of complete debridement and wound closure, with secondary endpoints including granulation tissue and changes in wound area.
To enhance the trial, MediWound has partnered with Solventum, MIMEDX, and Mölnlycke ensuring “consistent” wound management across every trial site.
An interim analysis of the trial is anticipated in mid-2026, after 65% of subjects complete their treatments, allowing for potential adaptive adjustments.
MediWound CEO Ofer Gonen said: “We are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade.
“EscharEx has already demonstrated its ability to effectively and rapidly debride chronic wounds in multiple Phase II trials, surpassing the current $375+ million market leader in wound debridement, Santyl.”
Alongside the VALUE study, MediWound is preparing to commence a head-to-head Phase II trial this year to compare the therapy against collagenase in VLU subjects, supporting the US biologics license application for the therapy.
The company is also gearing up for a Phase II/III trial targeting diabetic foot ulcers, anticipated to commence in 2026.
EscharEx, enriched with bromelain, is intended for topical application.
In July last year, the company published Phase II trial data indicating that EscharEx outperformed other non-surgical standard-of-care treatments for VLUs.
