MediWound Announces Completion of Patient Enrollment for Interim Assessment of the U.S. EscharEx Phase 2 Adaptive Design Study

MediWound announces that the enrollment target for an interim assessment of its EscharEx U.S. phase 2 adaptive design study to treat venous leg ulcers (VLUs) had been fulfilled.

FREMONT, CA: MediWound Ltd., a fully integrated biopharmaceutical firm dedicated to next-generation biotherapeutic solutions for tissue repair and regeneration, has announced that the enrollment target for an interim assessment of its EscharEx U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been fulfilled, and interim assessment would be completed by the end of July 2021. The pre-determined interim assessment aims to conduct a futility analysis and possibly modify the sample size. This trial, which aims to enrol 120 patients by the end of 2021, will evaluate the safety and effectiveness of EscharEx to a 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."

MediWound is also undertaking a phase 2 open-label, single-arm research to examine the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs as part of its broader EscharEx development program. 

MediWound is also undertaking a phase 2 open-label, single-arm research to examine the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs as a part of its broader EscharEx development program. This study expects to learn more about what happens in the wound bed during and after EscharEx debridement and to analyze its impact on biofilm burden, inflammation decrease and wound healing initiation. The results of this study are expected in the second half of 2021, according to MediWound.