Mediwound Ltd (MDWD)

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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

https://finance.yahoo.com/news/mediwound-announces-peer-reviewed-paper-120000332.html

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 wound healing,” said Sharon Malka, Chief Executive Officer of MediWound. “We believe EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. We also look forward to the interim assessment of our U.S Phase 2 adaptive design study in venous leg ulcers as we continue to advance EscharEx's clinical development program.”

About EscharEx

EscharEx, our bioactive therapy for debridement of chronic and other hard-to-heal wounds, is a product candidate in advanced stages of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy-to-use product candidate, for topical daily applications, which designed for the outpatient setting.

In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only few daily applications. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

About MediWound Ltd.

MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair. NexoBrid®, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.