- MediWound Ltd 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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