Israel’s MediWound Ltd., a maker of a pineapple-based gel to treat burn victims, said Tuesday that it got positive results of a key Phase 3 clinical trial of its treatment on children with severe thermal burns.
The study, which evaluated the efficacy of the firm’s gel compared with the standard of care alternative, met its three key targets, or endpoints, “with a high degree of statistical significance,” the Nasdaq-traded company said in a statement.
“NexoBrid demonstrated a significant reduction” in the time to achieve the complete removal of eschar, or dead tissue caused by a burn, and also a “significant reduction” in wound area that required surgery, while demonstrating it is not inferior to the standard of care regarding the quality of scars, the statement said.
The study also met certain secondary endpoints of the study, 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, the statement said
“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.”
MediWound’s technology is based on enzymes extracted from the pineapple plant stem in a complex pharmaceutical process.
“This study is one of the most comprehensive randomized controlled studies ever conducted in burn care generally and within the pediatric population specifically,” said Dr. Lior Rosenberg, MediWound’s chief medical technology officer. “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.”
The NexoBrid CIDS study was a multicenter, multinational, randomized, controlled, open label study, performed in children with deep partial thickness and full thickness thermal burns. The study’s objectives were to evaluate the efficacy and safety of treatment with NexoBrid compared with standard of care in hospitalized children with severe thermal burns of 1 percent to 30 percent of the total body surface area. The study enrolled 145 pediatric patients, from newborn to eighteen years of age, randomized to either NexoBrid or the standard of care, at a ratio of 1:1, across 36 burn centers worldwide.
Funding and support for this pivotal pediatric Phase 3 clinical study (CIDS) with NexoBrid was provided by the Biomedical Advanced Research and Development Authority within the US Department of Health and Human Services, the statement said.