MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric Study
Top-line Data is Expected in the Second Half of 2021
YAVNE, Israel, Oct. 28, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid® Phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study). Top-line results with 12 months follow up data anticipated during the second half of 2021. Additionally, the completion of the CIDS enrollment stage follows the U.S. Food and Drug Administration (FDA)’s recent agreement to allow the NexoBrid expanded access (NEXT) protocol to be expanded to include pediatric as well as adult burn patients.
“We are pleased to complete the enrollment stage of our NexoBrid pediatric Phase 3 study, which is one of the most comprehensive randomized controlled studies ever conducted in pediatric burn patients,” said Sharon Malka, Chief Executive Officer of MediWound. “The current mode of pediatric burn management requires intensive medical therapy, which poses challenges due to the surgical complexities in 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 treating severe burns in pediatric patients. We look forward to generating top-line results while we expand enrollment in our ongoing NEXT protocol to also include pediatric patients.”
Nick Colangelo, President and CEO of Vericel added, “Completing the enrollment stage of the CIDS study is an important step toward our goal of providing NexoBrid as a treatment option for pediatric patients with severe burns given NexoBrid’s potential to address the unique challenges in treating children with severe burns.”
CIDS is a Phase 3, multicenter, multinational, prospective, controlled, assessor-blinded study with 145 patients aged 0-18 years, randomized to be treated with either NexoBrid or standard-of-care, with follow-up periods at 12 months and at 24 months. The study’s objectives are to evaluate the efficacy and safety of NexoBrid compared with the standard-of-care in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). The study is being conducted primarily in the U.S. and Europe in accordance with a design and study protocol endorsed by both the European Medicines Agency (EMA) and the U.S. FDA. The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022. The study is fully funded by the Biomedical Advance Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
The ongoing NEXT protocol, which is supported and funded by BARDA, enables the continued clinical use of NexoBrid for U.S. patients during the review of the NexoBrid Biologics License Application (BLA). NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate.
The inclusion of pediatric patients in the NEXT protocol will allow additional physicians to expand their experience with NexoBrid in pediatric patients, ensure burn care preparedness, and expand the national capacity of trained physicians available to treat patients with NexoBrid in a non-declared emergency until the potential approval of the product for pediatric use in the U.S.
