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.  The Phase 3 study of EscharEx for venous leg ulcers (VLUs) is set to commence imminently, with FDA IND submission planned by year-end. All setup activities for initiation are complete, and the Company has successfully passed the required EMA inspection in preparation for the trial.

MediWound is planning a randomized, head-to-head Phase 2 study of EscharEx vs. collagenase in VLU patients. Set to begin in 2025, the trial will support the EscharEx Biologics License Application (BLA) submission and strengthen the Company’s commercialization strategy. MediWound has secured additional R&D collaborations for this study with Solventum and Mölnlycke to optimize trial consistency and patient outcomes. In addition, MediWound obtained €16.25 million in funding from the European Innovation Council (EIC) for the clinical development of EscharEx for treating diabetic foot ulcers (DFUs). This will expedite MediWound’s DFU program, and its associated revenue projections by four years. DFUs are more prevalent than VLUs, with a higher percentage of patients requiring debridement. Preparations for the DFU Phase 2/3 study are progressing as planned.

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).

The World Health Organization (WHO) recently recognized enzymatic debridement as a validated treatment for burn injuries. This recognition, featured in the WHO’s Standards and Recommendations for Burns Care in Mass Casualty Incidents (BMCI) guidelines for emergency medical teams, highlights NexoBrid’s critical role in emergency preparedness.

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.