MediWound Announced Positive Phase 3 Trial Results
MediWound Ltd, a biopharmaceutical company specializing in biotherapeutic solutions for tissue repair and regeneration, announced positive efficacy and safety results from its Phase 3 pediatric clinical study, Children Innovation Debridement Study (CIDS) with NexoBrid to treat children with severe thermal burns.1
The CIDS study was a multicenter, multinational, randomized, controlled, open-label study that examined the safety and efficacy of NexoBrid against the current standard of care in pediatric patients with deep partial thickness thermal burns (DPT) and total thickness (FT). Study participants were pediatric patients hospitalized with severe thermal burns ranging from 1% to 30% of total body surface area (TBSA). A total of 145 pediatric patients aged 0-18 years were recruited and randomized to the NexoBrid treatment arm or standard of care at a 1: 1 ratio at 36 burn treatment centers worldwide.
Initial results included the acute phase and analysis of 12-month follow-up data. Long-term data for aesthetic and functional measures, quality of lift and safety are expected in the first half of 2023.
The primary endpoints of the study were early removal of the pressure ulcer, reduction of the surgically excised wound area, and aesthetic and functional non-inferiority 12 months after wound closure. Secondary endpoints were reduction of surgical excision for pressure ulcer removal, blood loss, reduction of the need for autografting in DTP wounds, and aesthetic and functional non-inferiority at 24-month follow-up. after wound closure. To measure safety, the time required for complete wound closure as well as other factors were used.
All 3 primary endpoints were met in the study, with NexoBrid demonstrating a significant decrease in time to and to the wound area requiring surgery. It was also not below the current standard of care in terms of scar quality. Secondary endpoints achieved included a reduction in the incidence of surgical excision and a reduction in the need for autografting in deep partial burns and the amount of blood lost during the pressure ulcer removal process while being well tolerated. .
“This study is one of the most comprehensive randomized controlled studies ever conducted in burn care in general and in the pediatric population in particular. We thank all Principal Investigators and their teams, as well as patients and their families, for their work and commitment to advancing burn care, ”said Lior Rosenberg, MD, director of medical technology at MediWound. “We also thank the US Biomedical Advanced Research and Development Authority (BARDA) for their continued support for this project. The current mode of management of pediatric burns requires intensive medical treatment, which poses challenges due to the surgical complexity of treating young patients with severe burns. Having NexoBrid as a non-surgical option provides a minimally invasive alternative to the current surgical standard of care for the treatment of severe burns in pediatric patients.
The European Medicines Agency (EMA) approved the study design as part of the previously agreed Pediatric Investigation Plan (PIP) to support the extension of the indication label to include pediatric patients. The FDA cleared the expansion into U.S. burn centers under the same protocol, with the study aligning with the phase 3 DETECT (NCT01619111) trial protocols for the adult population.
Funding and support for this pivotal Pediatric Phase 3 (CIDS) clinical study with NexoBrid is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the leadership of the Assistant Secretary for Preparedness and Response (ASPR), at within the US Department of Health and Human Services (HHS), under current contract number HHSO100201500035C.
Ltd. Mr. Mediwound announces the first positive results of the pediatric phase 3 study (Cids) of nexobrid for the elimination of pressure ulcers from severe thermal burns. GlobeNewswire Newsroom. Posted July 20, 2021. Accessed July 29, 2021. https://www.globenewswire.com/news-release/2021/07/20/2265479/30505/en/MediWound-Announces-Positive-Topline-Results-from- Phase-3-Etude-Pediatrique-CIDS-of-NexoBrid-for-Eschar-Removal-of-Severe-Thermal-Burns.html