Benzinga | Jan 24, 2022 06:03AM EST

MediWound Announces Topline Results From Its U.S. Phase 2 Trial Of EscharEx For Debridement Of Chronic Wounds; Co. Reports Primary Endpoint Met With Highly Statistically Significant Results Along With No Observed Safety Issues

MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive topline results from its U.S. Phase 2 clinical study of EscharEx(r) 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 vehicle, with a p-value of 0.004.

The study randomized 120 patients, of which 119 patients were treated by either EscharEx (n=46), a gel vehicle (n=43), or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement (n=30). 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 vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). 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% (4/30).

In addition, the Independent Data Monitoring Committee reviewed the data of all patients treated and no safety concerns were identified in the study population. EscharEx was well-tolerated and overall safety was comparable between the arms. No differences were found in reported adverse events and no serious adverse event was related to study treatment. Patient baseline characteristics were comparable across all study arms.

"We are excited to report these robust topline results from our U.S. Phase 2 clinical study, which corroborate the results of our prior Phase 2 study. 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," said Sharon Malka, Chief Executive Officer of MediWound. "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."

Patient follow-up is ongoing and additional data, including secondary and exploratory endpoints as well as additional safety measurements, which will allow further evaluation of clinical benefits, is expected in the second quarter of 2022. MediWound currently expects to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (the "FDA") in the second half of 2022, to discuss program results and the potential Phase 3 pivotal plan for EscharEx.

Dr. Robert Snyder, Chief Medical Director of the EscharEx program added, "I continue to be impressed by the clinical data generated by the EscharEx trials. There is a great unmet medical need to effectively debride chronic wounds in a non-surgical and prompt manner, as debriding the wound is a critical first step for consequent wound management. I believe EscharEx holds great potential to be a significant and welcome addition to our treatment armamentarium for chronic wounds. We thank our partners, the investigative staff, and especially the patients and families for their commitment and perseverance in completing the study in the face of all the challenges posed by the pandemic."