MediWound Posts Promising EscharEx Data For Chronic Wounds
MediWound Ltd (NASDAQ: MDWD) has announced results from its U.S. Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs).
The study met its primary and secondary endpoints and wound closure safety measurements.
MediWound anticipates meeting with the FDA in 2H of 2022 for an End-of-Phase 2 meeting to discuss study results and a potential Phase 3 pivotal plan for EscharEx.
The study demonstrated that patients treated with EscharEx had a statistically significant higher incidence of complete debridement during the 14-day measurement period within up to 8 applications than gel vehicle (EscharEx: 63%) vs. gel vehicle: 30%.
Also See: MediWound Receives Additional $9M From BARDA For NexoBrid FDA Application Resubmission.
The estimated median time to complete debridement was 9 days for patients treated with EscharEx and 59 days for patients treated with non-surgical standard-of-care (NSSOC).
On average, complete debridement was achieved after 3.6 applications of EscharEx compared to 12.8 applications with NSSOC.
In addition, the study showed that EscharEx was safe and well-tolerated, and the overall safety was comparable between the arms.
There were no observed deleterious effects on wound closure and no material differences in reported adverse events.
Patients treated with EscharEx had a non-inferior incidence rate of complete wound closure compared to patients treated with gel vehicle.
Price Action: MDWD shares are up 10% at $1.98 during the premarket session on the last check Thursday.
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