Mediwound Ltd (MDWD)

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MediWound Announces Peer-Reviewed Publication of EscharEx In-Vivo Head-to-Head Comparator Study in the Journal of Wound Care

https://finance.yahoo.com/news/mediwound-announces-peer-reviewed-publication-113000250.html

EscharEx Treatment Demonstrated Superior Efficacy in Debridement of Eschar

YAVNE, Israel, Oct. 04, 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 a peer-reviewed publication in the Journal of Wound Care of an in vivo head-to-head study comparing EscharEx® and a commercial enzymatic debridement agent in the removal of chronic wound eschar. The study concluded that EscharEx was more effective than the commercially available collagenase in removing the eschar in this wound model.

The paper, entitled Development of a porcine chronic wound model: Evaluation of a bromelain-based enzymatic debriding agent1, describes the development of a novel porcine eschar model and compares the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic debridement agent, with commercially available collagenase-based debridement agent. Study results demonstrated that EscharEx treatment was more effective than the commercially available collagenase agent in debriding eschars in this novel porcine wound model.

“We are excited to have the study results published in this esteemed journal. The data clearly demonstrate EscharEx was superior to the commercially available enzymatic debriding agent in removing eschar,” said Sharon Malka, Chief Executive Officer of MediWound. “The data generated to date, together with the successful interim assessment of our ongoing U.S. phase 2 study to treat patients with venous leg ulcers, give us confidence in our clinical development plan, and we look forward to report data from our phase 2 study in the first half of next year. EscharEx may offer significant benefits for patients and healthcare professionals in the care of chronic wounds, addressing a clear medical need for a rapid and effective non-surgical debridement agent, and we believe it has the potential to change the standard of care in this sizeable market.”

Summary of study results

The study was conducted in collaboration with investigators from the Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, using a novel porcine wound model designed to evaluate the efficacy of enzymatic debridement agents. The primary objective of the study was to assess the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic agent (second generation EscharEx formulation), and to compare it with a commercially available collagenase debridement agent. Efficacy was evaluated based on the number of treatments of various concentrations of EscharEx and the collagenase agent necessary to achieve complete eschar removal (clinical assessment of at least 95% eschar removal from the center of the wound).

Key findings from the study included:

In all wounds treated with EscharEx and at all concentrations, the wound eschar was completely removed within a maximum of ten 24-hour applications. A trend towards dose-dependency was observed in the time to complete debridement.

None of the wounds treated with collagenase achieved >95% wound eschar removal after ten applications, the maximum number of applications needed to achieve complete debridement with EscharEx.

Pairwise comparisons between wounds treated with collagenase and each of the concentrations of EscharEx demonstrated significantly fewer applications required to achieve complete eschar removal with EscharEx (adjusted p<0.05).

Analysis of variance comparing mean number of applications required to achieve complete eschar removal also showed significant differences in means in favor of EscharEx (p<0.001).

Pairwise comparisons between wounds treated with collagenase and each of the concentrations of EscharEx demonstrated significantly higher percentage of complete eschar removal with the EscharEx at all time points.

About EscharEx

EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. 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, within a few daily applications.

EscharEx’s active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. 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.