Promising phase 3 results reported by MediWound

MediWound Ltd, a biopharmaceutical company with a focus in biotherapeutics 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 investigated the safety and efficacy of NexoBrid to the current standard of care in pediatric patients with deep partial thickness (DPT) and full thickness (FT) thermal burns. Study participants were pediatric patients hospitalized with severe thermal burns ranging from 1% to 30% of the total Body Surface Area (TBSA). A total of 145 pediatric patients were enrolled ages 0 to 18 years and randomized to either the NexoBrid or standard of care treatment arms at a 1:1 ratio across 36 burn centers globally.

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

The primary endpoints of the study were the early eschar removal, reduction of the wound area surgically excised, and non-inferiority cosmesis and function at 12 months following wound closures. The secondary endpoints were the decrease in surgical excision for eschar removal, blood loss, the reduced need for autograft in DPT wounds, and non-inferiority cosmesis and function at the 24-month follow up from wound closures. To measure safety, the time to complete wound closure along with other factors were used.

All 3 of the primary endpoints were met in the study, with NexoBrid demonstrating a significant decrease in time to and in wound area requiring surgery. It also was not inferior to the current standard of care in quality of scars. 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 loss during the eschar removal process while being well tolerated.

“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,” said Lior Rosenberg, MD, MediWound’s chief medical technology officer. “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.”

The European Medicines Agency (EMA) endorsed the study design as a part of the previously agreed Pediatric Investigation Plan (PIP) to support the indication label expansion to include pediatric patients. The FDA allowed expansion into the US burn centers under the same protocol with the study aligning to the DETECT (NCT01619111) phase 3 trial protocols for adult population.

Disclosure

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.

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 eschar removal of severe thermal burns. GlobeNewswire 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