Advancing Bromelain-Based Therapies for Better Standard of Care
Our capabilities are well demonstrated in our diversified products and pipeline.
NexoBrid, our 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 marketed in the European Union as well as in other international markets and is at a registration stage in the U.S. NexoBrid PDUFA date is January 1, 2023. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
The European Medicines Agency (EMA) recently validated for review the Company’s Type II Variation to expand NexoBrid’s currently approved indication for the pediatric population.
EscharEx, our next-generation bioactive therapy 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.
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.
NexoBrid® Eschar removal of deep partial and full thickness burns
Registration Stage in the U.S.
NEXT Expanded access treatment protocol
CIDS Pediatric phase 3 study
EscharEx® Debridement of chronic wounds
ChornEx U.S. Phase 2 adaptive design study
PharmEx Phase 2 pharmacology study
MW005 Non-melanoma skin cancer
Phase I/II study in BCC