Benzinga | Dec 6, 2021 07:17AM EST

MediWound Completes Enrollment Of Its EscharEx U.S. Phase 2 Adaptive Design Study

MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced it has completed patient enrollment in its U.S. Phase 2 adaptive design clinical study evaluating the safety and efficacy of EscharEx(r) in debridement of venous leg ulcers (VLUs) compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

In July 2021, the Company reported a positive outcome from its planned interim assessment on sample-size re-estimation for this study, conducted after 80 patients were treated, with no changes to the original study sample size of 120 patients and no safety concerns identified. Topline data from clinical study is now anticipated in the first quarter of 2022.

"Completing enrollment in our U.S. phase 2 trial is an important step in advancing EscharEx as a non-surgical rapid and effective debridement agent with the potential to improve on the current standard of care for chronic wound management," said Sharon Malka, Chief Executive Officer of MediWound. "Chronic wound care is a significant market opportunity for us with an addressable market of over one billion dollars annually, and we believe EscharEx could be a meaningful part of that market. We look forward to sharing topline data from this study in the first quarter of 2022."

Dr. Robert Snyder, Chief Medical Director of EscharEx program added, "We are pleased to see EscharEx move forward in its development as a potential therapy for people suffering from chronic wounds. We thank our partners, the investigative staff, and especially the patients and families for their commitment and perseverance in completing enrollment in the face of all the challenges posed by the pandemic."

The study is a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs. The study enrolled 120 patients at approximately 20 clinical sites, primarily in the U.S. Study participants were randomized to either EscharEx, placebo control or non-surgical standard-of-care of either enzymatic or autolytic debridement, at a ratio of 3:3:2, with a three-month follow-up. 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.

The study included a pre-defined interim assessment for futility and potential sample size adjustment. The Independent Data Monitoring Committee's (IDMC) conducted the pre-specified interim conditional power assessment, after 80 patients out of the originally targeted of 120 patients completed the debridement treatment and recommended that no changes to the original enrollment target of 120 patients was required to maintain the pre-specified statistical power of 80 percent or greater on the study's primary endpoint of incidence of complete debridement compared with gel vehicle. In addition, the IDMC reviewed the data of all subjects treated and no safety concerns were identified in the study population.

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.