MediWound Initiates the VALUE Global Phase 3 Pivotal Trial of EscharEx for Treatment of Venous Leg Ulcers

MediWound Ltd. recently announced the initiation of VALUE, a global, pivotal Phase 3 trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs).

“We are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,” said Ofer Gonen, Chief Executive Officer of MediWound. “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. EscharEx has already demonstrated its ability to effectively and rapidly debride chronic wounds in multiple Phase 2 trials, surpassing the current $375+ million market leader in wound debridement, SANTYL. We are confident that EscharEx will provide meaningful benefits to patients, healthcare providers, and payors alike.”

The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the US and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over 2 weeks, followed by 10 weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks.

The study co-primary endpoints are the incidence of complete debridement and the incidence of complete wound closure. Secondary endpoints include the incidence of complete granulation tissue, time to debridement, time to complete wound closure, and changes in wound area. Safety and tolerability of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026.

To support the trial, MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes.

In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase 2 study in 2025, comparing EscharEx to collagenase in VLU patients. This Phase 2 trial is designed to support the US Biologics License Application (BLA) submission for EscharEx and strengthen MediWound’s commercialization strategy. Furthermore, the company is advancing preparations for an adaptive design Phase 2/3 clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026.

Venous leg ulcers (VLUs) affect approximately 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the US. These ulcers typically develop on the lower extremities due to chronic venous insufficiency. VLUs are characterized by large, shallow wounds that can cause severe pain, infection, and disability, highlighting the urgent need for effective treatment options. Debridement, a critical first step in managing these wounds, is performed in 68% of cases and is commonly achieved through enzymatic methods like SANTYL, autolytic debridement, or sharp debridement.

EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes, enriched with bromelain, designed for topical and easy-to-use daily applications. In three previous Phase 2 trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing. EscharEx is currently being investigated in a global Phase 3 study for the treatment of venous leg ulcers (VLUs). Preparations are underway for a Phase 2/3 study targeting diabetic foot ulcers (DFUs).

MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries.

MediWound’s first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx, a promising candidate currently in Phase 3 development for the debridement of chronic wounds. Phase 2 clinical trials have shown EscharEx has distinct advantages over the currently available $375+ million drug for wound debridement, presenting a unique opportunity for significant market growth. For more information, visit www.mediwound.com.