Next Generation Enzymatic Theraputics Focused on Non-Surgical Tissue Repair

Our capabilities are well demonstrated in our diversified products and pipeline.

EscharEx^®, our Phase 3 biologic for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of clinical development. In three Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications. Positive results were recieved from its U.S. Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs). The study met its primary and key secondary endpoints with statistically significant results compared to control arms, showing significant improvement over the current non-surgical standard-of-care, with no deleterious effect on wound closure and no observed safety issues. In addition, EscharEx recieved positive results from its Phase 2 pharmacology study for the debridement of lower leg ulcers. The data showed EscharEx to be a safe, rapid, and effective treatment for the debridement of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The study also demonstrated EscharEx reduces wound size, biofilm, and bacterial burden. MediWound is set to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024 with preparations for the Phase II/III study targeting Diabetic Foot Ulcers already in progress.

NexoBrid^®, our FDA approved, commercial orphan biological product for eschar removal of severe thermal burns, is a bromelain-based biological product, containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours and does not harm surrounding viable tissue. Nexobrid is currently approved in the United States, European Union and other international markets.

The U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid®, allowing its use for eschar removal in pediatric patients from newborns to eighteen years old with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. across all age groups, aligning with its approvals in the European Union and Japan.

NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

MW005, our topical enzymatic therapy for the treatment of non-melanoma skin cancers received positive initial data from the Company’s U.S. Phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) . The initial data showed MW005 to be safe and well-tolerated, and target lesions clearance data provided clinical efficacy proof-of-concept. Additional study results are expected by year-end.