Affirms the clear path forward for the Company’s global Phase III study of EscharEx in venous leg ulcers
The CHMP notified the company that it concurs with the overall design of the proposed study. (Credit: Diana Polekhina on Unsplash)
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization.
The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies.
“We are very pleased to receive positive Scientific Advice from EMA supporting our Phase III development plan for EscharEx. The constructive feedback we have garnered from both the U.S. Food and Drug Administration (FDA) and the EMA provides consensus, empowering us to conduct this pivotal Phase III study on a global scale,” said Ofer Gonen, Chief Executive Officer of MediWound. “EscharEx addresses an important medical need for patients suffering from chronic wounds, and we look forward to bringing this next-generation therapy to market.”
In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each. Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid, which has been approved for debridement of thermal burns in the U.S. and Europe.
Source: Company Press Release