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Next Generation Enzymatic Technology Platform
Next-generation enzymatic theraputics focused on for non-surgical tissue repair
Overview
Proprietary Platform Technology with Diversified Portfolio
The company’s unique platform is a mixture of proteolytic enzymes enriched in bromelain. These enzymes are extracted from the pineapple stem, purified and enriched utilizing our proprietary enzymes enrichment technology.
This core technology is the common denominator underlying our marketed product and all our biologic products under development. Bromelain has multiple methods of action that apply to a variety of indications. Our goal is to pioneer non-surgical solutions that can replace existing standards of care, with a current focus in therapeutics for tissue repair.
MediWound’s enzyme enrichment technology harnesses nature’s wisdom while maximizing its biotherapeutic properties for medical therapies.
The process is characterized by the ability to enrich the natural substance with its most active components while maintaining their highest activity during all process stages, from plant harvesting through the pharmaceutical product on the shelf.
Animation by Visual Science, 2023
From Plant to Drug
A Proprietary Enzyme Enrichment Technology for Protein-Based Therapies
Harvesting the pineapple stem
Protein extraction
Partial purification, enrichment and stabilization
Drug substance
Our pharmaceutical product ingredient (API) is a complex mixture of proteins, enriched in bromelain, extracted from the stem of the pineapple. The API possess various pharmacological properties, including:
- Debridement activity
- Anti-cancerous activity
The debriding activity is mediated by the proteolytic activity of the enzymes, which leads to degradation of denatured collagen and necrotic tissues
The anti-carcinogenic mode of action is mediated through inhibition of cancer cells by proliferation and activation of pro-apoptotic mechanisms, which lead to reduction of tumor formation and tumor volume
Our Focus
Next-Generation Bioactive Therapies
NexoBrid® is our commercial orphan biologic drug for early non-surgical eschar removal of deep-partial and full-thickness thermal burns. It is a bromelain-based gel containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the United States, European Union, Japan, India, and other international markets.
The U.S. Food and Drug Administration (FDA) 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.
Its development is supported by the US Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS).
EscharEx® based on the same active pharmaceutical ingredient as NexoBrid and indicated for the debridement of chronic and hard-to-heal wounds, is MediWound’s lead biologic under development. Results from Phase 2 studies show that EscharEx is significantly more effective and faster than SOC or placebo control in debridement of VLUs and DFUs, with a good safety and tolerability profile. EscharEx is currently being investigated in a global Phase III study for the treatment of venous leg ulcers (VLUs). Preparations are underway for a Phase II/III study targeting diabetic foot ulcers (DFUs).
MW005, our topical biological drug under development for the treatment of low-risk Basal Cell Carcinoma (BCC). In a Phase I/II open-label, multicenter, randomized clinical trial conducted in the U.S., MW005 was shown to be safe, well-tolerated, and an effective treatment for BCC with patients demonstrating complete clinical and histological clearance of target lesions.