The company announced it has begun treating patients in its US Phase 2 adaptive design clinical study of EscharEx to treat venous leg ulcers.
MediWound (NASDAQ:MDWD) has announced it has begun patient treatment in its US Phase 2 adaptive design clinical study of EscharEx to treat venous leg ulcers (VLUs).
As quoted in the press release:
The trial is designed to assess safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement), and includes a pre-defined interim assessment anticipated by the end of 2020.
“We are thrilled to initiate this U.S. Phase 2 adaptive design study of EscharEx, that is built on extensive prior research, including the positive data from the completed Phase 2 study of the first-generation EscharEx,” said Sharon Malka, Chief Executive Officer of MediWound. “The study enables the comparison of EscharEx to placebo control, as well as a head-to-head comparison with the current non-surgical standard of care in the U.S.”
Mr. Malka continued, “We believe EscharEx is a game-changer, addressing a significant unmet medical need for patients affected by chronic wounds with a sizable market opportunity and commercial validation for enzymatic debridement. We are encouraged by the strong interest expressed in the clinical community for participating in this study, and we look forward to working closely with physicians and patients as we advance this exciting development program.”
The multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLU’s. The study is expected to enroll 174 patients at approximately 25 clinical sites, primarily in the U.S. Study participants will be randomized to either EscharEx, placebo control or non-surgical standard-of-care of either Santyl or Hydrogel, at a ratio of 1:1:1, with a three month follow-up. The study includes an interim assessment for futility and potential sample size adjustment once approximately 50 percent of patients complete treatment. The primary endpoint is incidence of complete debridement compared to gel vehicle placebo control. Secondary endpoints include time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue and quality of life. Incidence and time to achieve wound closure will be assessed as safety measurements.