Promising phase 3 results reported by MediWound

MediWound Ltd, a biopharmaceutical company with a focus on biotherapeutic solutions for tissue repair and regeneration, announced positive efficacy and safety results from its Phase 3 pediatric clinical trial, Children Innovation Debridement Study (CIDS) of NexoBrid for the treatment of children with severe thermal burns.1

The CIDS study was a multicenter, multinational, randomized, controlled, open-label study investigating the safety and efficacy of NexoBrid under current standard of care in pediatric patients with deep partial thickness (DPT) and full thickness (FT) thermal burns. The 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 to 18 years were enrolled and randomized to the NexoBrid treatment arms or the standard treatment in a 1:1 ratio at 36 burn centers worldwide.

Topline results included the acute phase and 12-month follow-up data analysis. Long-term data for cosmetics and function, elevator quality and safety measurements are expected in the first half of 2023.

The primary endpoints of the study were early scab removal, reduction of surgically resected wound area, and non-inferiority cosmesis and function 12 months after wound closure. The secondary endpoints were the reduction in surgical excision for scab removal, blood loss, the reduced need for autograft in DPT wounds, and non-inferiority cosmesis and function after 24 months of wound closure follow-up. To measure safety, the time to close the wound along with other factors were used.

All 3 primary endpoints were met in the study, with NexoBrid demonstrating a significant reduction in time to and in the wound area requiring surgery. It was also not inferior to today’s standard of care in scar quality. The secondary endpoints achieved included a reduction in the incidence of surgical excision and reduction in the need for autograft in deep partial burns and the amount of blood lost during the scab removal process, while being well tolerated.

“This study is one of the most comprehensive randomized controlled trials ever conducted in burn care in general and within the pediatric population in particular. We thank all the principal investigators and their teams, as well as patients and their families, for their work and commitment to improve burn care,” said Lior Rosenberg, MD, MediWound’s chief of medical technology. “We also thank the US Biomedical Advanced Research and Development Authority (BARDA) for their continued support of this project. The current mode of pediatric burn treatment requires intensive medical therapy, which is challenging due to the surgical complexity of treating young patients with severe burns. NexoBrid as a non-surgical option offers a minimally invasive alternative to current surgical standards 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 allowed expansion into US burn centers under the same protocol, with the study conforming to the DETECT (NCT01619111) Phase 3 trial protocols for adult populations.

Revelation

Funding and support for this pivotal Phase 3 clinical trial (CIDS) in children 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 current contract number HHSO100201500035C.

This article was originally published by Dermatology Times.

Reference

1. Ltd M. Mediwound announces positive topline results from phase 3 pediatric study (Cids) of nexobrid for scab removal from severe thermal burns. Globe News Wire News Room. Published 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-Pediatric-Study-CIDS-of-NexoBrid-for-Eschar-Removal-of-Severe-Thermal-Burns.html

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