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news.Israel-based biopharmaceutical firm MediWound has started its second Phase II clinical trial of EscharEx for the treatment of chronic and other hard-to-heal wounds.
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The company said that EscharEx is based on its patented proteolytic enzyme technology.
About 72 patients are expected to be enrolled in the prospective, randomized, controlled, multicenter Phase II trial, which is expected to be conducted at about 10 clinical sites.
The Phase II trial is designed to assess the safety and efficacy of EscharEx compared with gel vehicle for the treatment of a variety of chronic and other hard-to-heal wounds, including diabetic foot ulcers (DFUs), venous ulcers and post-surgical or traumatic hard-to-heal wounds.
The blinded trial intends to evaluate non-viable tissue removal, wound bed preparation and wound healing as well as other additional endpoints.
The company has carried out a Phase II feasibility trial of EscharEx to treat chronic and other hard-to-heal wounds in 24 patients at two clinical sites in Israel and the results have showed efficacy in debriding various wound etiologies such as DFUs, venous ulcers, pressure sores and other post-surgical or post-trauma hard-to-heal wounds.
MediWound president and chief executive officer Gal Cohen said the company’s enthusiasm for EscharEx to treat chronic and hard-to-heal wounds is based on the wealth of existing development data with its lead product, NexoBrid, to remove eschar in severe burns as well as clinical data from its Phase II feasibility study with its technology in chronic and hard-to-heal wounds.
"As EscharEx is based on the same technology as NexoBrid, we believe its development program is significantly de-risked and we look forward to a positive outcome with our second Phase 2 trial," Cohen said.
"Pending clinical and regulatory success, we believe that there is significant market opportunity for EscharEx as more than 14 million people in Europe and the US alone, suffer from chronic wounds. Chronic and other hard-to-heal wounds represent a $25 billion burden to the U.S. healthcare system each year.
"Unfortunately, the incidence of patients suffering from such chronic wound conditions is growing due to the overall aging of the population and a higher prevalence of obesity and diabetes, among other factors."