Press Release Details

Results Highlight the Safety and Efficacy in Hard-to-Heal Wounds

SAWC to Take Place in Phoenix, Arizona on April 6-10, 2022

YAVNE, Israel, March 29, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a poster and oral presentation of its EscharEx^® clinical data at the 35^th Symposium on Advanced Wound Care (SAWC) Spring Conference taking place in Phoenix, Arizona on April 6-10, 2022 (Home | SAWC Spring).

The oral presentation, titled: “Introduction to EscharEx: An Innovative Enzymatic Solution for the Debridement of Hard to Heal Wounds,” will be moderated by Vickie R. Driver, DPM, MS, FACFAS FAAWC (University of Virginia and Inova Healthcare) and will feature, John C. Lantis, M.D. (Mount Sinai West Hospital and Icahn School of Medicine), Cyaandi R. Dove, DPM (Advanced Wound & Ankle Center, Las Vegas,  and Robert J. Snyder, D.P.M., M.Sc. (Barry University), who will discuss  results from recent clinical studies. The topics include: the importance of debridement in wound management, the preliminary efficacy and safety data from two well controlled clinical studies in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs), along with a case series from a clinical pharmacology study demonstrating EscharEx's fast and effective debriding activity accompanied with reduction in biofilm and bacterial load.

In addition to the oral presentation, the Company will present an abstract poster, titled: “Results from an Ongoing Open Phase 2 Study Assessing the Safety, Efficacy and Pharmacological Effects of Bromelain-based Enzymatic Debridement on Biofilm, Microbial loads and Cytokines in patients with DFU and VLU.” The poster will present EscharEx phase 2 pharmacology study data of debridement efficacy while reducing biofilm and bacterial bioburden.

“We are excited to have the opportunity to highlight EscharEx at the upcoming SAWC Spring conference and share the recent positive clinical data from our ongoing phase 2 clinical trials with the wound care community,” said Sharon Malka, Chief Executive Officer of MediWound. “It is a great opportunity to showcase EscharEx’s potential as a best-in-class, non-surgical debridement option for the millions of patients suffering from chronic wounds. We believe EscharEx, with its encouraging safety and efficacy data, is well-positioned to potentially be a meaningful part of this market.”

The SAWC, the official meeting site of the Wound Healing Society, is the world’s most comprehensive wound event of the year featuring scientific abstracts highlighting updates on the most critical topics in wound care. The Symposium on Advanced Wound Care Spring now in its 35th year, serves as a forum to connect the entire wound care team, physicians (DO, DPM, MD), nurses, physical therapists, researchers, scientists, and dietitians, with the foremost experts in wound care to improve patient outcomes through education.

About EscharEx

EscharEx is a bioactive therapy for debridement of chronic and other hard-to-heal wounds in advanced stages of clinical development. Designed for the outpatient setting, EscharEx is an easy-to-use concentrate of proteolytic enzymes enriched in bromelain for topical daily applications.

In two completed Phase 2 trials, EscharEx was well-tolerated and demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds with only few daily applications. EscharEx’s mechanism of action is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product and currently in a U.S. Phase 2 adaptive design study.

As part of its broader EscharEx development program, MediWound is also conducting a Phase 2 open-label, single arm study at three U.S. clinical sites. The study is designed to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in the debridement of lower leg ulcers (VLUs and diabetic foot ulcers) in up to fifteen patients.

About MediWound Ltd.

MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, biotherapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care, and tissue repair.

NexoBrid^®, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

EscharEx^®, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which 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 often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and 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 ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Reports on Form 6-K and other filings with the SEC 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.

Source: MediWound Ltd.