MediWound announces 'favorable' results from NexoBrid Phase 2 study
MediWound announces positive results from a phase 2 study that evaluated the safety, pharmacokinetics and efficacy of NexoBrid in hospitalized children and adults with severe thermal burns. The multicenter, open-label, single-arm study was conducted in Europe, Israel and India and included 36 patients with severe burns of 4% to 30% total body surface area, or TBSA. NexoBrid was applied to burns of up to 15% TBSA in one session, and when the wound area to be treated was more than 15% TBSA, NexoBrid was applied in two separate sessions, each up to 15% TBSA. Trial results showed that the use of NexoBrid was safe and effective. Furthermore, the pharmacokinetic profile following NexoBrid's first and second topical application was comparable, suggesting no concern with accumulation following a second topical application of NexoBrid. Surgical excision of large surfaces of eschar results in substantial surgical burden on these very severe patients and involves massive blood loss. Surgery is often limited by the availability of the extensive donor site required, or by patient conditions that might not withstand general anesthesia or the significant burden of surgical debridement of such large surface areas.