U.S. Phase 3 DETECT Study
YAVNE, Israel, June 11, 2018 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed enrollment in NexoBrid®U.S. Phase 3 DETECT study. Top-line acute data are currently expected around year end 2018.
“We are happy to achieve this important milestone of completing the enrollment in NexoBrid Phase 3 study, which is one of the most comprehensive randomized controlled studies ever conducted in burn care, and we believe it will support our Biological License Application (BLA) submission to the FDA,” said Gal Cohen, president and chief executive officer of MediWound. “Prior studies of NexoBrid have shown positive results and we eagerly await our top-line acute data. Subject to a successful study outcome, we plan to meet with the FDA to discuss the BLA submission plan. We warmly thank our Principal Investigators, their teams and everyone involved in the study for their commitment and dedication in an effort to advance burn care.”