The poster, featuring the phase 2 pharmacology study promising results, was selected and featured during the Grand Rounds Session of the SAWC Wound Care Learning Network
YAVNE, Israel, April 12, 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 that clinical data from the Company’s EscharEx® phase 2 trials was highlighted in a poster and oral presentation at the 35th Symposium on Advanced Wound Care (SAWC) Spring Conference. The abstract poster was one of ten posters, out of the 235 posters presented, to be selected for certificate and featured during the Poster Grand Rounds session of the SAWC spring conference.
The poster entitled: “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,” featured data from an ongoing Phase 2 study that showed EscharEx to debride wounds and promote wound area reduction, while reducing biofilm and bacterial bioburden safely and effectively.
EscharEx was also featured in an oral presentation entitled: “Introduction to EscharEx: An Innovative Enzymatic Solution for the Debridement of Hard to Heal Wounds,” during an educational symposium, where several key opinion leaders highlighted the importance of debridement in wound management and the unmet medical need. They also covered the efficacy and safety data from the Company’s two well controlled clinical studies in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs), in addition to a case series from a clinical phase 2 pharmacology study demonstrating EscharEx's fast and effective debriding activity accompanied with reduction in biofilm and bacterial load.
“The SAWC Spring Conference brought together many of the top wound care specialists from around the globe, and we were very excited to share our EscharEx data with this esteemed group,” said Sharon Malka, Chief Executive Officer of MediWound. “There was a consistent acknowledgment among wound care specialists of need for new debridement agent. The tremendous interest from the wound care medical community in our educational symposium, which was well received, was very encouraging. We also were honored to receive recognition for our poster which was selected as one of the top ten posters. The initial receptivity and high interest expressed by wound care specialists, strengthened our belief that EscharEx, with its promising safety and efficacy data, has the potential to be a meaningful part of over billion-dollar wound care 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.
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, bio-therapeutic 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; risks related to our contracts with BARDA; 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, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021, 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.
Chief Financial Officer