Phase III clinical DETECT study of NexoBrid meets primary endpoint in burns treatment.- MediWound

MediWound announced that it has met its primary and all secondary endpoints in its pivotal U.S. Phase III clinical study (DETECT) with NexoBrid to treat patients with deep partial thickness (DPT) and full thickness (FT) thermal burns intended for submission for Biological License Application (BLA) from the FDA. The NexoBrid DETECT study is a prospective, controlled, multi-center, multi-national, assessor blinded Phase III study in 175 patients randomized to either NexoBrid, Standard of Care (SOC), or the Gel Vehicle placebo at a ratio of 3:3:1, with 12- and 24-month long-term safety follow-up. The study met its primary endpoint with statistical significance. Patients treated with NexoBrid demonstrated a significantly higher incidence of complete eschar removal compared with patients treated with the Gel Vehicle (NexoBrid: 93.3% (70/75) vs. Gel Vehicle: 4.0% (1/25), p<0.00011).>

The study also included secondary endpoints that were all met with statistical significance and provided further insight on several efficacy parameters. Patients treated with NexoBrid demonstrated a significantly lower incidence of surgical eschar removal compared with patients treated with SOC (NexoBrid: 4.0% (3/75) vs. SOC: 72.0% (54/72). Patients treated with NexoBrid demonstrated a significantly shorter time to achieve complete eschar removal compared with patients treated with SOC (median time - NexoBrid: 1.0 days vs. SOC: 3.8 days). Patients treated with NexoBrid incurred significantly lower blood loss during the eschar removal procedure compared with patients treated with SOC (mean volume � NexoBrid: 14.2 ml vs. SOC: 814.5 ml. Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC. The overall safety profile of NexoBrid in the study is good, and consistent with the safety data known from previous studies.