MediWound Initiates U.S. Phase 3 Trial With NexoBrid(R) to Treat Severe Burns

MediWound Ltd.

, a biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces initiation of the DETECT (DEbride and ProTECT) U.S. Phase 3 clinical study with NexoBrid to treat patients with deep partial thickness (DPT) and full thickness (FT) thermal burns. NexoBrid is a topical pharmaceutical product that removes dead or damaged tissue, known as eschar, in a single, four-hour application without harming the surrounding healthy tissue. The DETECT study is a prospective, controlled, multicenter, multinational, assessor blinded Phase 3 study in 175 patients randomized to either NexoBrid, Standard-Of-Care (SOC) or Gel Vehicle (3:3:1), with 12- and 24-months follow-up. The study is expected to involve approximately 30 burn centers. The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar earlier and reducing surgical needs in hospitalized patients with severe burns. Complete eschar removal is the primary endpoint of the study and will be tested against the vehicle arm. Secondary endpoints include reduction in surgical burden, earlier eschar removal and blood loss, which will be tested against the SOC arm. Wound closure and long-term cosmesis will be assessed as safety endpoints and tested against the SOC arm. "We are particularly pleased to be initiating our U.S. Phase 3 clinical trial with NexoBrid to treat patients with DPT and FT thermal burns. After further discussions with the U.S. and EU regulatory authorities, this streamlined study protocol evaluates NexoBrid on a singular primary endpoint of eschar removal compared with vehicle rather than on three co-primary endpoints as had been the case in the previous version of the study protocol. The other two previous primary endpoints of reduction in surgical burden and cosmesis are now a secondary endpoint and a safety endpoint, respectively. As a result of this efficient protocol and, given the significant positive results in eschar removal in our past Phase 3 study, we reduced the number of patients to 175. We expect to have top-line results on the acute primary and secondary endpoints in the first half of 2017, and to have the long-term 12-month and 24-month follow-up results in the first half of 2018 and 2019, respectively," stated Gal Cohen, President and Chief Executive Officer of MediWound. "Based on the approved study design and with the product available to treat severe burn patients in Europe, we may also discuss with the FDA the possibility of submitting a Biologics License Application after completion of the acute phase of the study, subject to favorable results in the acute phase, with plans to supplement the application with the 12-month and 24-month long term follow up data when it is available. This would potentially accelerate NexoBrid's availability to U.S. patients suffering with severe burns. We believe NexoBrid represents a significant improvement for burn patients. We strive to duplicate the positive efficacy and safety results from the previous Phase 3 study conducted in Europe in the DETECT study with an aim to provide U.S. burn patients with this innovative treatment that is already available throughout Europe," he added.