Wound debridement therapy company MediWound has published Phase II trial data showing that its treatment, EscharEx, is superior at treating venous leg ulcers compared to other non-surgical standard-of-care solutions. The Phase II ChronicEx trial (NCT03588130) data, published in the eClinicalMedicine journal, part of the Lancet Discovery Science, indicates EscharEx’s effectiveness in wound bed preparation. MediWound aims to start a Phase III trial evaluating wound debridement therapy EscharEx as a treatment for venous leg ulcers in the second half of this year.
“Removing non-viable tissue and promoting well-vascularized 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 wound debridement therapy 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.
Wound Debridement Therapy EscharEx Shows Superior Results in Faster Healing and Better Granulation
The median time to complete debridement was nine days for wound debridement therapy 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 wound debridement therapyv EscharEx compared to 25.6% and 10.0% for placebo and non-surgical standard-of-care treatments respectively.
EscharEx is a bioactive therapy consisting 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 wound debridement therapy EscharEx in another chronic wound condition, diabetic foot ulcers, in the second half of 2025.
Wound therapy advancements by MediWound have shown promising results for their EscharEx treatment, particularly in treating venous leg ulcers. The Phase II ChronicEx trial data demonstrated wound debridement therapy EscharEx’s superior performance over other non-surgical standard-of-care solutions in achieving optimal wound bed preparation. With 63% of wound debridement therapy EscharEx-treated patients achieving complete debridement in a median time of nine days, compared to significantly longer durations for placebo and other treatments, EscharEx shows potential as a viable alternative to surgical debridement.
Wound Debridement Therapy EscharEx to Enter Phase III Trial with Promising Early Results
The study’s principal investigator, Dr. John C. Lantis, emphasized the importance of removing non-viable tissue and promoting well-vascularized granulation tissue for successful wound healing. The upcoming Phase III trial, set to begin in the second half of the year, will further evaluate wound debridement therapy EscharEx’s efficacy in treating venous leg ulcers. MediWound also plans to explore the treatment’s potential for diabetic foot ulcers in the latter half of 2025.
EscharEx, a bioactive therapy composed of proteolytic enzymes, has shown significant advantages in wound bed preparation, reducing the median time to complete debridement and increasing the incidence of healthy granulation tissue cover. MediWound’s commitment to advancing wound care is further evidenced by its other product, NexoBrid, which received FDA approval for treating thermal burns.
With a focus on enhancing wound healing outcomes and providing alternatives to surgical methods, MediWound’s wound debridement therapy EscharEx represents a promising development in the field of chronic wound treatment. The anticipated Phase III trial will be crucial in determining the therapy’s potential to improve patient care and expand treatment options for those suffering from venous leg ulcers.
Resource: Medical Device Network, July 30, 2024
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