MediWound has published Phase II trial data showing that its wound debridement therapy, EscharEx, is superior at treating venous leg ulcers than other non-surgical standard-of-care solutions.
The Phase II ChronicEx trial (NCT03588130) data was published in the eClinicalMedicine journal, part of the Lancet Discovery Science.
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MediWound aims to start a Phase III trial evaluating EscharEx as a treatment for venous leg ulcers in the second half of this year.
“Removing non-viable tissue and promoting well-vascularised granulation tissue are essential steps in wound bed preparation, which is crucial for successful wound healing,” stated Dr John C Lantis, principal investigator in the ChronEx study.
“The significant superiority of EscharEx over the current non-surgical standard of care in achieving optimal wound bed preparation could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. This will be a primary focus of the upcoming EscharEx Phase III trial in treating venous leg ulcers.”
The ChronEx study enrolled 119 patients, who received either EscharEx, a placebo gel vehicle or a non-surgical standard of care treatment such as Collagenase Santyl ointment hydrogels, medical grade honey, and non-active dressings. The trial met its primary endpoint with 63% of participants who received EscharEx achieving complete debridement, compared to 30.2% and 13.3% in the placebo and non-surgical standard of care treatments respectively.
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By GlobalDataThe median time to complete debridement was nine days for EscharEx, compared to 63 days for placebo and 59 days for non-surgical standard-of-care treatments. Furthermore, the incidence of a complete cover of the wound bed with healthy granulation tissue during the daily treatment period was 50.0% for EscharEx compared to 25.6% and 10.0% for placebo and non-surgical standard-of-care treatments respectively.
EscharEx is a bioactive therapy that consists of a concentration of proteolytic enzymes. It is being developed for debridement of chronic and other hard-to-heal wounds. MediWound also plans to investigate EscharEx in another chronic wound condition, diabetic foot ulcers in the second half of 2025.
Another product in MediWound’s portfolio is NexoBrid (anacaulase-bcdb) treatment. It was approved by the US Food and Drug Administration to eliminate eschar in adults with deep partial-thickness and/or full-thickness thermal burns in January.
