MediWound launches EscharEx U.S. clinical development program
MediWound announced its U.S. clinical development plan for EscharEx, the Company's topical biological drug candidate for the debridement of chronic and hard-to-heal wounds. MediWound plans to initiate an adaptive comprehensive adequately controlled Phase 2 study in the fourth quarter of 2019 for second generation EscharEx. The study is designed to assess safety, efficacy and clinical benefit of EscharEx compared to placebo control and non-surgical standard of care with a pre-defined interim assessment. The study is designed as a multicenter, prospective, randomized assessor-blinded study to treat venous leg ulcer patients, in about 25 clinical sites, primarily in the U.S. The study is expected to enroll 174 patients randomized to either EscharEx, gel vehicle placebo or non-surgical standard-of-care of either Santyl or Hydrogel, at a ratio of 1:1:1, with a 3 months follow-up and with an interim assessment for futility and sample size adjustment, once the trial has achieved approximately 50% of the target patients enrollment. Incidence of complete debridement will be the primary endpoint compared to gel vehicle placebo. Secondary endpoints will include reduction of pain, time to achieve complete debridement, reduction of wound area, granulation tissue and quality of life, and will be compared with gel vehicle placebo and SOC. Incidence and time to achieve wound closure will be assessed as safety measurement.