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MediWound Announces Peer-Reviewed Paper Detailing EscharEx Phase 2 Randomized Control Trial Results Published in the Online Wound Repair and Regeneration Journal
Study Findings Demonstrate Strong Results in Debriding Venous Leg Ulcers and Diabetic Foot Ulcers Interim Assessment of Ongoing U.S. Phase II Adaptive Design
About this update from Mediwound Ltd.
[{"type":"text","content":"Study Findings Demonstrate Strong Results in Debriding Venous Leg Ulcers and Diabetic Foot Ulcers Interim Assessment of Ongoing U.S. Phase II Adaptive Design Study in Venus Leg Ulcers Expected End of July 2021 YAVNE, Israel, July 09, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication, detailing the results of a phase 2 randomized control trial of its wound debriding product candidate EscharEx®, has been published in the Wound Repair and Regeneration Journal. An interim assessment of EscharEx's U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) is expected by end of July 2021. The paper, entitled Bromelain-based enzymatic debridement of chronic wounds: Results of a multicenter randomized controlled trial,1 summarizes the results of a phase 2 assessor blinded study of EscharEx (first generation) for the debridement of chronic and hard-to-heal wounds. The study, conducted at 15 clinical sites in Israel and Europe, evaluated the safety and efficacy of EscharEx compared with a hydrogel vehicle in a variety of chronic and hard-to-heal wounds. Seventy-three patients suffering from lower extremity ulcers, such as diabetic foot ulcers (DFUs), venous legs ulcers (VLUs), and post-surgical or traumatic hard-to-heal wounds, were enrolled in this trial. Patients were randomized to topical treatment by either EscharEx or its gel vehicle for up to 10 daily 4-hour applications, and then continued follow-up for up to 6 months. The EscharEx arm achieved a significantly higher incidence of complete debridement compared to the gel vehicle arm, thus meeting the primary endpoint of this study. The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area, and wound healing scores during the debridement period. There were no significant differences between the arms in the incidence of complete wound closure and in the mean time to complete wound closure, and no significant safety issues were observed. “We are very excited to have our phase 2 data published in this respected journal. The data clearly demonstrate that EscharEx debrides severe wounds rapidly and effectively with no deleterious effect on ...