MediWound (NSDQ:MDWD) touted data from a phase II trial of its EscharEx topical biological drug for debridement of chronic and other hard-to-heal wounds. The data includes a follow-up period of 6 months from the last treatment to 3 months from wound closure.
The randomized phase II trial enrolled 73 patients with a variety of chronic and hard-to-heal wounds including diabetic foot ulcers and venous leg ulcers. Patients received either EscharEx or a hydrogel placebo.
The primary endpoint of the trial was incidence of complete debridement, non-viable tissue removal, at the end of 10 days of treatment. Secondary endpoints included time to debridement, wound healing and other efficacy and safety measures, according to MediWound.
The study met its primary endpoints, the company wrote in a regulatory filing. Patients treated with EscharEx had a higher incidence of complete debridement compared with patients treated with the hydrogel placebo and achieved debridement faster than their counterparts in the control group.
“We completed the study follow-up period and are happy to reaffirm the previously reported positive results. These final results reinforce our belief that EscharEx has the potential to become a first-in-class topical debridement treatment for chronic wounds,” MediWound CEO Gal Cohen said in prepared remarks. “As reported previously, following the successful completion of this first cohort of the Phase 2 study, we initiated a second cohort of 32 patients to demonstrate safety over extended periods of application to further support product application periods of 24 to 48 hours, which we believe will enhance convenience and compliance. Patients with DFUs and VLUs are randomized to either EscharEx or gel vehicle treatment at a ratio of 2:1. We expect to complete the second cohort of the Phase II study and to report top-line data in mid-2017.”
MDWD shares were trading at $5.70 apiece in mid-afternoon activity, up 9.6%.