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MediWound Announces Positive Topline Results from Phase 3 Pediatric Study (CIDS) of NexoBrid for Eschar Removal of Severe Thermal Burns
Primary Endpoints Met with Highly Statistically Significant Results Compared with Standard-of-Care YAVNE, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- MediWound
About this update from Mediwound Ltd.
[{"type":"text","content":"Primary Endpoints Met with Highly Statistically Significant Results Compared with Standard-of-Care\nYAVNE, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced positive topline results from its pivotal phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study) with NexoBrid® to treat children with severe thermal burns, evaluating the efficacy and safety compared with standard-of-care (SOC). The study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and reduction in need for autograft in deep partial burns, as well as a favorable trend in reduction of blood loss during the eschar removal process. In addition, the study showed that NexoBrid was safe and well-tolerated. “We are thrilled to see such robust results across all primary endpoints, which corroborate the positive results of our pivotal phase 3 clinical studies in adult patients, and clearly demonstrate the significant beneficial impact NexoBrid has on the lives of pediatric burn patients,” said Sharon Malka, Chief Executive Officer of MediWound. \"It is gratifying to know that NexoBrid, with these highly compelling top-line results, is one step closer to becoming available as a treatment option for pediatric patients with severe burns.\" Dr. Lior Rosenberg, MediWound's Chief Medical Technology Officer, added, “This study is one of the most comprehensive randomized controlled studies ever conducted in burn care generally and within the pediatric population specifically. We thank all the Principal Investigators and their teams, as well as the patients and their families, for their work and commitment to advance burn care. We also thank the U.S. Biomedical Advanced Research and Development Authority (BARDA) for their continued support for this project. The current mode of pediatric burn management...