MediWound has reported positive top-line results from the Phase III DETECT study after the trial met its primary and secondary endpoints.
DETECT is a prospective, controlled, multi-centre trial of NexoBrid for the treatment of patients with deep partial thickness (DPT) and full thickness (FT) thermal burns.
The primary endpoint of the multi-national, assessor-blinded trial was the complete removal of eschar, measured by comparing all randomised patients in the NexoBrid arm with the patients in the Gel Vehicle control arm.
Results showed that patients who received NexoBrid achieved a significantly higher incidence (93.3%) of complete eschar removal compared with patients treated with gel vehicle (4%).
Secondary endpoints of the trial comprised reduction in the need for surgical eschar removal, earlier eschar removal, and blood loss, which were assessed against the patients in the standard of care (SOC) control arm.
The trial also compared the time to complete wound closure and other standard safety measures with the SOC control arm.
MediWound president and CEO Gal Cohen said: “We are thrilled to announce these robust positive results across all endpoints, which corroborate our previous positive EU Phase III clinical study results and clearly demonstrate the significant beneficial impact NexoBrid has on patients’ lives.
“Our innovative product, NexoBrid, represents a new paradigm in burn care management.
“These significant results clearly confirm its ability to remove the eschar earlier while significantly reducing patients’ surgical burden, two outcomes that are both clinically and pharmacoeconomically important.”
MediWound enrolled 175 patients who were randomised in 3:3:1 ratio to receive either NexoBrid, SOC, or the Gel Vehicle placebo as part of the DETECT study,
The trial included 12 and 24-month long-term safety follow-up period. It also included 44 burn centers.