Mediwound Ltd (MDWD)

[midastouch017]

MediWound Enrolls First Patient in Phase 2 Pharmacology Study of EscharEx

https://finance.yahoo.com/news/mediwound-enrolls-first-patient-phase-113000419.html

Thu, April 22, 2021, 2:30 PM

Data Expected Second-Half 2021

YAVNE, Israel, April 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it has enrolled the first patient in its phase 2 pharmacology study of EscharEx®, its next-generation enzymatic debridement agent under development for chronic wounds, with data expected in the second half of 2021.

The pharmacology study, to be conducted in 2-3 U.S. clinical sites, is a phase 2 prospective, open label, single arm study. The objective of the study is to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in debridement of lower leg ulcers (venous leg ulcers and diabetic foot ulcers) in up to 15 patients. Data collection includes the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression.

“Chronic wounds represent a significant unmet medical need for many patients, and EscharEx, with its positive safety and efficacy results generated in our previous phase 2 studies, can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers,” said Sharon Malka, Chief Executive Officer of MediWound. “We anticipate data from the pharmacology study in the second half of this year, in addition to the interim assessment in our EscharEx phase 2 adaptive design study.”

“There is wide consensus among clinicians that infection and microbial biofilm impedes the healing process and prolongs wound healing. The treatment of biofilm in chronic wounds is rapidly becoming a primary objective of wound care,” said Dr. Robert Snyder, Chief Medical Director of EscharEx program. “EscharEx may convert a chronic wound into one that is acute while also disrupting biofilm and planktonic bacteria, which could delay wound healing.”

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 has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx 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 cleaves and removes 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 Biofilm1

Biofilm is created through the attachment of bacteria to elements in the extracellular polymeric substances (EPS). The EPS, which is 50% to 90% of the total biofilm organic matter, is comprised of dead host tissue, microorganisms’ secretions, proteins, nucleic acids, lipids, and polysaccharides. Biofilms have been reported to interfere with normal wound healing, apparently by ‘locking’ the wound bed into a chronic inflammatory state that leads to elevated levels of tissue-degrading proteases and reactive oxygen species which damage cells and molecules needed for healing. A large percentage of bacteria in biofilm communities are metabolically dormant, and low metabolic rates make antibiotics ineffective. The EPS substances and their interactions are targets for therapeutic biofilm elimination.

Bacterial biofilms have been shown to prolong the inflammatory process, which is detrimental to wound healing because of the degradation of the growth factors required for cellular proliferation and migration necessary for wound healing.