MediWound's EscharEx Mid-Stage Trial Meets Primary Goal In Venous Leg Ulcers

MediWound Ltd MDWD has posted topline results from its U.S. Phase 2 study of EscharEx for the debridement (removal of dead or infected skin tissue for wound healing) of venous leg ulcers (VLUs). 

• 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). 
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• The study met its primary endpoint, demonstrating that patients treated with EscharEx showed a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications than patients treated with gel vehicle (EscharEx: 63% vs. gel vehicle: 30%). 
• The incidence of complete debridement of the non-surgical standard-of-care arm during the same 14-day measurement period was 13%.
• In addition, no safety concerns were identified. EscharEx was well-tolerated, and overall safety was comparable between the arms. 
• Patient follow-up is ongoing and additional data is expected in the second quarter of 2022. 
• MediWound expects to request an end-of-Phase 2 meeting with the FDA in 2H of 2022.
• Designed for the outpatient setting, EscharEx is an easy-to-use concentrate of proteolytic enzymes enriched in bromelain for daily topical applications.
• Price Action: MDWD shares closed at $2.43 on Friday.