Israeli biotherapeutic solutions for tissue repair developer MediWound Ltd. (Nasdaq: MDWD) today reported positive results on a Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel, with a p-value of 0.004.
The study randomized 120 patients, of which 119 patients were treated by either EscharEx, a gel, or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement. The study met its primary endpoint with high degree of statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to patients treated with gel. After adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size and age, regions, and sites, EscharEx efficacy superiority remained statistically significant compared to gel vehicle. Incidence of complete debridement of the non-surgical standard-of-care arm, during the same 14-day measurement period, was 13%.
The Independent Data Monitoring Committee also reviewed the data of all patients treated and no safety concerns were identified in the study population.
MediWound CEO Sharon Malka said, "The primary endpoint efficacy data are highly encouraging and further reinforce our belief that EscharEx has the potential to become a best-in-class non-surgical debridement option for the millions of patients suffering from chronic wounds. Chronic wound care is a billion-dollar market opportunity, and we believe EscharEx is well-positioned to potentially be a meaningful part of that market. We look forward to reviewing the full data set in the coming months with the goal of advancing this exciting program into pivotal Phase 3 clinical trials."
Ofer Gonen, CEO of Clal Biotechnology Industries (TASE: CBI), which has a 35% stake in MediWound, said, "A number of leading companies in the field approached MediWound even before the trial results were published. In our estimation, in light of these unequivocal results, interest in the company will strengthen even more. Clal Biotech will strive to maximize this opportunity for the benefit of all MediWound's shareholders."
Published by Globes, Israel business news - en.globes.co.il - on January 24, 2022.
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