Primary Endpoints Met with Highly Statistically Significant Results Compared with Standard-of-Care
YAVNE, 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 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.”
CIDS Study Design and Objectives
The NexoBrid CIDS study is a multicenter, multinational, randomized, controlled, open label study, performed in children with deep partial thickness (DPT) and full thickness (FT) thermal burns. The study's objectives are to evaluate the efficacy and safety of treatment with NexoBrid compared with standard of care (SOC) in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). The study enrolled 145 pediatric patients, from newborn to eighteen years of age, randomized to either NexoBrid or SOC at a ratio of 1:1, across 36 burn centers worldwide. Topline results include acute phase and twelve-month follow-up data analysis. The long-term follow-up for cosmesis and function, quality of life and safety measurements is ongoing, and data is expected in the first half of 2023.
The European Medicines Agency (“EMA”) endorsed the study design as part of the agreed-upon Pediatric Investigational Plan (“PIP”) to support the indication label expansion to include pediatric patients. The primary endpoints included early eschar removal, reduction of wound area surgically excised (surgical need) and non-inferiority cosmesis and function at twelve months follow-up from wound closure. Secondary endpoints included reduction in the need for surgical excision for eschar removal (surgical need), blood loss, reduction of the need for autograft in DPT wounds and non-inferiority in cosmesis and function at twenty-four months follow-up from wound closure. Non-inferiority of the time to complete wound closure and other standard safety measurements were also compared with the SOC control arm.
The study was expanded to include burn centers in the United States following agreement with the FDA, under the same protocol with alignment to the U.S. phase 3 study (DETECT) protocol for adult population. The non-inferiority of cosmesis and function at twelve months and twenty-four months from wound closure were defined as safety measurements. In addition, reduction in surgical need was measured only by reduction in incidence of surgical excision for eschar removal.
Funding and support for this pivotal pediatric Phase 3 clinical study (CIDS) with NexoBrid is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing contract number HHSO100201500035C.
Summary of Study Topline Results
Demographics and other baseline characteristics
The overall patient demographics and wound baseline characteristics were comparable across study arms.
Primary Endpoints
The study met its three primary endpoints with highly statistical significance. Patients treated with NexoBrid demonstrated a significantly shorter time to achieve complete eschar removal compared with patients treated with SOC (median time to complete eschar removal - NexoBrid: 0.99 days vs. SOC: 5.99 days, p=0.00081).
Patients treated with NexoBrid demonstrated a significant reduction in surgical need for excisional eschar removal as measured by an analysis of percent wound area surgically excised for eschar removal. Patients treated with NexoBrid incurred a significantly lower percent of wound area surgically excised for eschar removal compared with patients treated with SOC (NexoBrid: 1.5% vs. SOC: 48.1%, p