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YAVNE, Israel, July 09, 2021 (GLOBE NEWSWIRE) – MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that a revised publication, detailing the results of a phase randomized controlled trial 2 of its candidate product for wound debridement, EscharExÂ®, was published in the Wound repair and regeneration Newspaper. An interim evaluation of EscharEx’s Phase 2 adaptive design study in the United States for the treatment of venous leg ulcers (UVV) is expected by the end of July 2021.
The paper, titled Bromelain-based enzymatic debridement of chronic wounds: results from a multicenter randomized controlled trial,1 summarizes the results of a phase 2 blinded study of EscharEx (first generation) for the debridement of chronic and difficult to heal wounds. The study, conducted at 15 clinical sites in Israel and Europe, evaluated the safety and efficacy of EscharEx compared to a hydrogel vehicle in a variety of chronic and difficult to heal wounds. Seventy-three patients with lower extremity ulcers, such as diabetic foot ulcers (UPD), venous leg ulcers (UVV), and difficult-to-heal post-surgical or traumatic wounds, were included in this trial. Patients were randomized to receive topical treatment with EscharEx or its vehicle gel for up to 10 daily applications of 4 hours, followed by continuous follow-up for up to 6 months.
The EscharEx arm achieved a significantly higher incidence of complete debridement compared to the vehicle gel arm, thus meeting the primary endpoint of this study. The EscharEx and vehicle gel arms achieved similar reductions in wound area, non-viable tissue area, and wound healing scores during the debridement period. There was no significant difference between the arms in the incidence of complete wound closure and the mean time to complete wound closure, and no significant safety concerns were observed.
âWe are very pleased that our Phase 2 data is published in this respected journal. The data clearly demonstrates that EscharEx debrides severe wounds quickly and effectively without deleterious wound healing, âsaid Sharon Malka, CEO of MediWound. âWe believe EscharEx has the potential to improve the current standard of care and have a significant impact on the management of chronic wounds. We also look forward to the interim evaluation of our US Phase 2 adaptive design study in venous leg ulcers as we continue to advance EscharEx’s clinical development program.
EscharEx, our bioactive therapy for the debridement of chronic wounds and other difficult-to-heal wounds, is a product candidate at an advanced stage of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched with bromelain, is an easy-to-use product candidate, for daily topical applications, designed for the ambulatory setting.
In two Phase 2 trials, EscharEx was well tolerated and demonstrated to be safe and effective in the debridement of various chronic wounds and other difficult-to-heal wounds with only a few daily applications. The mechanism of action of EscharEx is mediated by proteolytic enzymes which cleave and remove necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a Phase 2 adaptive design study in the United States.
About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures and markets novel, cost-effective biotherapeutic solutions for tissue repair and regeneration. Our strategy is based on our enzymatic technology platform, focused on next-generation bioactive therapies for burns, wound care and tissue repair. NexoBridÂ®, our commercial orphan biologic for non-surgical pressure ulcer removal from deep, partial and total thermal burns, is a bromelain-based biologic containing a sterile blend of proteolytic enzymes that selectively eliminates pressure ulcers in four hours without damage surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is in the registration stage in the United States. NexoBrid is supported by the US Biomedical Advanced Research and Development Authority (BARDA).
EscharEx, our next-generation bioactive therapy for the debridement of chronic and difficult-to-heal wounds, is a product candidate at an advanced stage of development. In two Phase 2 studies, EscharEx was well tolerated and demonstrated to be safe and effective in the debridement of various chronic wounds and other difficult-to-heal wounds in a few daily applications.
MW005, a topical biologic drug for the treatment of skin cancers other than melanoma, is a clinical stage candidate in development.
Committed to innovation, we are committed to improving the quality of care and the lives of patients. For more information, please visit www.mediwound.com.
Caution regarding forward-looking statements
MediWound warns you that all statements other than statements of historical fact included in this press release that deal with activities, events or developments that we predict, believe or anticipate will occur or may occur in the future are forward-looking statements. Although we believe we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations regarding future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict. and many that are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements contained in this press release. These statements are often, but not always, made using words or phrases such as “anticipate”, “intend”, “estimate”, “plan”, “expect”, ” continue “,” believe “,” orient, “” prospect “,” target “,” future “,” potential “,” goals “and similar words or expressions, or future or conditional verbs such as” will “,” should “,” should “,” could “,” may “or similar expressions.
Specifically, this press release contains forward-looking statements regarding the anticipated progress, development, objectives, expectations and business potential of NexoBrid and EscharEx. Factors that may cause results to differ materially from those indicated in this document include the inherent uncertainties associated with the timing and conduct of preclinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and market NexoBrid, including its potential for business growth and market demand for the product; competitive developments; whether the FDA will provide market authorization for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the phase 2 study, the timing of the interim evaluation, the impact of applicable laws and regulations; and the uncertainties associated with the scope, magnitude and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the rate at which government agencies, such as the FDA, will review and approve regulatory submissions. Quarantines and additional government-imposed âshelter-at-homeâ requirements or other gradual mitigation efforts may also impact our ability to source supplies for our operations or our capacity or capacity. 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 fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission (âSECâ) on February 25. 2020, Quarterly Reports on Form 6-K and other SEC filings from time to time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release, except as required by law.
1 Bromelain-based enzymatic debridement of chronic wounds: results from a multicenter randomized controlled trial – Shoham – – Wound Repair and Regeneration – Wiley Online Library