MediWound Announces Collaboration With MIMEDX On EscharEx Phase III Study

MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has entered into a research collaboration agreement with MIMEDX Group, Inc (NASDAQ:MDXG). MIMEDX will provide its market leading placental tissue allograft EPIFIX® to be used during the wound healing phase of the EscharEx® Phase III study in venous leg ulcers (VLUs).
 

"For our Phase III study, the U.S. Food and Drug Administration (FDA) emphasized the importance of minimizing product variation in the wound healing process. Existing data clearly demonstrates notable differences in outcomes depending on the allograft used," explained Ofer Gonen, Chief Executive Officer of MediWound. "We are thrilled to offer patients in our study a market-leading and extensively studied allograft, EPIFIX. By incorporating EPIFIX into the trial, we aim to maintain consistency among study subjects and optimize the potential for complete healing throughout the study duration."

EscharEx is being evaluated in a Phase III study for efficacy and safety in the debridement of chronic wounds in VLUs, the first indication being studied. In the trial, once a subject's wound is completely debrided and the wound bed is covered with 100% granulation tissue, the patient will have either an autograft (a minor surgical procedure using the patient's own tissue as the graft) or allograft (some form of donated tissue) applied to the wound to facilitate complete closure.

Joseph H. Capper, Chief Executive Officer of MIMEDX stated, "We are excited to collaborate with MediWound on this important study. Their expertise and success in developing and bringing debridement biologics to market, coupled with the strong body of evidence we have generated for EPIFIX over the years, positions this Phase III study in VLUs as a significant milestone in the wound care field. Notably, there have been no new FDA-approved drugs in this category since 1997. Being the largest and most comprehensive VLU study in the past decade, we anticipate this well-structured trial will provide invaluable evidence-based insights to the advanced wound care industry," added Capper.