MediWound Publishes EscharEx® Phase II Study Results for Venous Leg Ulcers

MediWound Ltd., a leader in next-generation enzymatic therapeutics for tissue repair, has announced the peer-reviewed publication of the Phase II ChronEx study on EscharEx in the journal eClinicalMedicine, part of THE LANCET Discovery Science portfolio. This study focuses on assessing the safety and efficacy of EscharEx for treating Venous Leg Ulcers (VLU). The publication is titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study."

Dr. John C. Lantis, Chief of Surgery at Mount Sinai West Hospital and principal investigator in the ChronEx study, emphasized the importance of a non-surgical treatment for debridement of VLUs. Dr. Lantis highlighted that removing non-viable tissue and promoting healthy granulation tissue are critical steps in wound bed preparation, essential for successful wound healing. The significant superiority of EscharEx over the current non-surgical standard of care (NSSOC) could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. This will be the primary focus of the upcoming EscharEx Phase III trial in treating VLUs.

The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe, and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or NSSOC, which included SANTYL®, hydrogels, medical grade honey, and non-active dressings. The treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks.

Key outcomes from the study include:

- A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm.
- Baseline characteristics of patients and wounds were comparable across all study arms.
- The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001).
- The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016).
- The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001).
- Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms.
- The safety profile of EscharEx was comparable to both NSSOC and the placebo.

EscharEx® is a bioactive, multimodal debridement therapy for chronic and other hard-to-heal wounds, currently in advanced stages of clinical development. It consists of proteolytic enzymes enriched with bromelain for topical, easy-to-use daily applications. In several Phase II trials, EscharEx has been shown to be safe and well-tolerated, demonstrating efficacy in debridement, promotion of granulation tissue, and reduction of bioburden and biofilm in various hard-to-heal wounds. MediWound is set to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024, and a Phase II/III study targeting Diabetic Foot Ulcers in the second half of 2025.

MediWound Ltd. specializes in the development, production, and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences while reducing costs and unnecessary surgeries. The company'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 surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including EscharEx®, a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages and market expansion opportunities.