Benzinga | Jun 9, 2021 04:32PM EDT

MediWound Says Completes Patient Enrollment For Interim Assessment Of U.S. EscharEx Phase 2 Adaptive Design Study

MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the enrollment target of patients for an interim assessment of its EscharEx(r) U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).



"We are very pleased to reach this important clinical milestone, and we look forward to the interim assessment next month," said Sharon Malka, Chief Executive Officer of MediWound. "With a clear unmet medical need for a non-surgical rapid and effective debridement agent in the outpatient setting, EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. EscharEx represents a significant market opportunity for MediWound, with an addressable market of over a billion dollars annually."

As part of the Company's broader EscharEx development program, MediWound is also conducting a phase 2 open-label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs. The objective of this study is to gain a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx, and to assess its effect on biofilm burden, reduction in inflammation, and the initiation of wound healing. MediWound expects to generate data from this study in the second half of 2021.