- MediWound Ltd MDWD has announced topline results from Phase 3 pediatric study with NexoBrid to treat severe thermal burns.
- The 145-subject study met its three primary endpoints.
- NexoBrid demonstrated a significant reduction in time to achieve complete eschar (burn tissue) removal and a substantial decrease in wound area requiring surgical excision while demonstrating non-inferiority to standard-of-care in quality of scars.
- The study also met certain secondary endpoints showing a statistically significant reduction in the incidence of surgical excision and a drop in the need for autograft in deep partial burns and a favorable trend in reducing blood loss during the eschar removal process.
- In addition, the study showed that NexoBrid was safe and well-tolerated.
- The long-term follow-up for cosmesis and function, quality of life, and safety measurements are ongoing, and data is expected in 1H of 2023.
- No deleterious effect on wound healing was observed, and NexoBrid was found to be safe and well-tolerated.
- No safety concerns were identified in the study population.
- NexoBrid is approved in the European Union and other international markets.
- Price Action: MDWD shares are trading higher by 16.3% at $5.22 premarket on the last check Tuesday.
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