Successful Completion of In-Vivo Head-to-Head Comparator Study of EscharEx versus a Commercial Enzymatic Debridement Agent
Data to be Published in a Peer-Reviewed Journal in First Half 2021
YAVNE, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the successful completion of a pre-clinical study designed to evaluate the debridement efficacy of EscharEx®, a novel bromelain-based enzymatic debridement agent, in a porcine hard-to-heal wound model, and compare its efficacy with an FDA approved and commercially available collagenase enzymatic debridement agent. The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. Results from the study will be published in a peer-reviewed journal in the first half of 2021.
“We are encouraged by the robust results of this in-vivo study comparing EscharEx to the commercially available enzymatic debriding agent,” said Sharon Malka, Chief Executive Officer of MediWound. “Given the superior efficacy of EscharEx versus the comparator enzymatic debridement agent demonstrated in this study, as well as the positive safety and efficacy results generated in our previous phase 2 study, we believe EscharEx has the potential to become a game-changer in a sizeable market. EscharEx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers. We look forward to the publication of these study results in a peer-reviewed journal, and we continue to advance our U.S Phase 2 adaptive design study in venous leg ulcers.”
The study, conducted in collaboration with a U.S. research center, was performed as part of MediWound’s pharmacological evaluation of EscharEx’s effect on chronic wounds, using a novel porcine eschar model designed to evaluate the efficacy of enzymatic debridement agents. The primary objective of the study was to compare the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic agent (second generation EscharEx formulation), 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 needed to achieve complete eschar removal (greater than 95%), as assessed clinically.
With EscharEx treatment, complete eschar removal was achieved in all treated wounds, at all dose concentrations, within a maximum of ten 24-hour applications, and dose-dependency was observed in the time to complete debridement. After ten applications, the maximum number of applications needed to achieve complete eschar removal with EscharEx at its lower dose, none of the wounds treated with the collagenase enzymatic agent achieved complete eschar removal.
