Mediwound ltd. initiates u.s. phase 2 adaptive design study of escharex® for treatment of venous leg ulcers
Mediwound ltd. announced the initiation of patient treatment in its u.s. phase 2 adaptive design clinical study of escharex, a topical biologic drug candidate designed to enzymatically debride chronic wounds, for the treatment of venous leg ulcers (vlu’s). 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. 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% 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.