YAVNE, Israel, June 9, 2021 (Global News Agency)-MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the patient enrollment goals for its EscarEx mid-term evaluation® The Phase 2 adaptive design study for the treatment of venous lower extremity ulcers (VLU) in the United States has been completed, and a mid-term evaluation is expected at the end of July 2021. The pre-determined mid-term assessment is used for invalid analysis and potential sample size adjustments. The goal of this study is to recruit a total of 120 patients by the end of 2021, and aims to evaluate EscarEx with gel carriers (placebo-controlled) and non-surgical standard care (enzymatic or autolytic debridement).
“We are very happy to reach this important clinical milestone and we look forward to the mid-term evaluation next month,” said Sharon Malka, CEO of MediWound. “As the medical needs for non-surgical rapid and effective debridement agents are clearly unmet in the outpatient environment, EscarEx has the potential to improve current standards of care and have a meaningful impact on chronic wound management. EscarEx represents an important market opportunity for MediWound. In other words, its potential market exceeds 1 billion U.S. dollars per year.”
As part of the company’s broader EscarEx development plan, MediWound is also conducting a Phase 2 open-label, one-arm study to evaluate the pharmacology of EscarEx in up to 15 patients with diabetic foot ulcers (DFU) and VLU effect. The purpose of this study is to better understand what happens on the wound bed during and after the use of EscarEx to debride the wound, and to evaluate its impact on biofilm load, reduction of inflammation, and initiation of wound healing. MediWound expects to generate data from this study in the second half of 2021.
EscharEx is our bioactive therapy for debridement of chronic and other difficult-to-heal wounds. It is a candidate product in the late stage of clinical development. EscharEx is a proteolytic enzyme concentrate rich in bromelain, an easy-to-use product candidate, suitable for topical daily applications, and designed for outpatient settings.
In two phase 2 trials, EscarEx was well tolerated and proved to be safe and effective in the debridement of various chronic and other difficult-to-heal wounds, with few daily applications. EscharEx’s mechanism of action is mediated by proteolytic enzymes, which cut and remove necrotic tissue and prepare the wound bed for healing. EscharEx is a research product and is currently in the second phase of adaptive design research in the United States.
About MediWound Limited company
MediWound is a biopharmaceutical company that develops, manufactures and commercializes new, cost-effective biotherapeutic solutions for tissue repair and regeneration. Our strategy utilizes our enzyme technology platform to focus on the next generation of bioactive therapies for burns, wound care and tissue repair.
NexoBrid®, Our commercial orphan biological product for non-surgical removal of deep, partial and full-thickness thermal burn eschar. It is a bromelain-based biological product that contains a sterile mixture of proteolytic enzymes that can be selectively removed within four hours Burns the eschar without harming the surrounding living tissues. NexoBrid is currently sold in the European Union and other international markets. On June 29, 2020, a Biologics License Application (BLA) was submitted to the U.S. FDA, and the Prescription Drug User Fee Act (PDUFA) was assigned a target date of June 29, 2021. Authority (BARDA).
EscharEx is our next-generation bioactive therapy for the debridement of chronic and difficult-to-heal wounds. It is a candidate product in the late stage of development. In two phase 2 studies, EscarEx was well tolerated and proved its safety and effectiveness in debridement of various chronic and other difficult-to-heal wounds in several applications per day.
MW005 is a topical biopharmaceutical for the treatment of non-melanoma skin cancer. It is a clinical candidate product under development.
We are committed to innovation and committed to improving the quality of care and the lives of patients.For more information, please visit www.mediwound.com.
Note on forward-looking statements
MediWound reminds you that all statements are forward-looking statements, except for the statements of historical facts contained in this press release regarding the activities, events or developments we anticipate, believe, or anticipate that will or may occur in the future. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations of future events that affect us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict. And many of them are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are usually (but not always) expressed through the use of words or phrases such as “anticipates”, “intends”, “estimates”, “plans”, “anticipates”, “continues”, “believes”, “guides”, etc. , “Look forward”, “goal”, “future”, “potential”, “target” and similar words or phrases, or future or conditional verbs, such as “will”, “would”, “should”, “could”, “Maybe” or similar expressions.
Specifically, this press release contains forward-looking statements regarding the expected progress, development, goals, expectations and commercial potential of NexoBrid and EscarEx. Factors that may cause the results to differ materially from those described in this article include inherent uncertainties related to the timing and implementation of preclinical and clinical trials and product development activities; the timing or possibility of regulatory approval; the successful development and commercialization of NexoBrid Ability, including its commercial growth potential and product market demand; development of competition; whether the FDA will approve the listing of NexoBrid in the United States; the ability to successfully develop and commercialize EcharEx, the design of the second phase of the study, the time of mid-term evaluation, applicable laws and regulations The impact of the COVID-19 pandemic; and the uncertainty associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we cannot predict how the pandemic will affect the overall healthcare infrastructure, including the speed at which government agencies (such as the FDA) review and approve regulatory submissions. Additional quarantine and “shelter at home” requirements or other incremental mitigation measures implemented by the government may also affect our ability to purchase supplies for our operations, or our ability or ability to manufacture, sell, and support the use of NexoBrid in the future.
These and other important factors are discussed in more detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on February 25, 2020, Form Quarterly Report Submit 6-K and other documents to the SEC from time to time. These forward-looking statements reflect MediWound’s current views as of the date of this article, and MediWound undertakes and expressly disclaims any obligation to update any of these forward-looking statements to reflect their respective views or events or circumstances that occurred after that date. Change unless required by law.