MediWound reports positive results from Phase 2 trial of EscharEx for debridement of chronic wounds
Jan. 24, 2022 6:20 AM ETMediWound Ltd. (MDWD)
By: Mamta Mayani, SA News Editor
MediWound (NASDAQ:MDWD) announces positive topline results from its U.S. Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs).
The study randomized 120 patients, of which 119 patients were treated by either EscharEx (n=46), a gel vehicle (n=43), or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement (n=30).
The study met its primary endpoint with high degree of statistical significance.
Patients treated with EscharEx demonstrated a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to patients treated with gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004).
After adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size and age, regions, and sites, EscharEx efficacy superiority remained statistically significant compared to gel vehicle.
In addition, the Independent Data Monitoring Committee reviewed the data and no safety concerns were identified.
EscharEx was well-tolerated and overall safety was comparable between the arms.
Patient follow-up is ongoing and additional data, including secondary and exploratory endpoints as well as additional safety measurements, which will allow further evaluation of clinical benefits, expected in Q2 2022.
MDWD currently expects to request an end-of-Phase 2 meeting with the FDA in H2 2022, to discuss program results and the potential Phase 3 plan for EscharEx.
EscharEx is a bioactive therapy for debridement of chronic and other hard-to-heal wounds in advanced stages of clinical development.
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