Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification
Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification
DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment completion remain on track for end of the first quarter of 2027
YAVNE, Israel, September 14, 2026 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the independent Data and Safety Monitoring Board (DSMB) completed its pre-specified periodic safety review of the ongoing Phase III VALUE study evaluating the safety and efficacy of EscharEx® in patients with venous leg ulcers (VLU). Following its review, the DSMB did not identify any safety concerns and recommended that the study continue as planned without modification. MediWound also continues to expect the study’s pre-specified interim sample-size reassessment and completion of patient enrollment by the end of the first quarter of 2027.
“We are encouraged by the DSMB’s recommendation to continue the VALUE study as planned and without modification,” said Ofer Gonen, Chief Executive Officer of MediWound. “The DSMB’s findings are consistent with the favorable safety profile observed across the EscharEx clinical program and support our continued execution of this pivotal Phase III study.”
About the VALUE Trial
VALUE (NCT06568627) is a global, multicenter, randomized, double-blind, placebo-controlled Phase III pivotal trial evaluating the efficacy and safety of EscharEx® in patients with venous leg ulcers (VLU). The study is designed to enroll 216 patients across approximately 40 sites in the U.S., Europe, and Israel, randomized in a 1:1 ratio to receive EscharEx or placebo. The co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure. The study includes a pre-specified interim sample-size reassessment after 65% of patients have completed the 12-week wound-management period. The interim reassessment and completion of enrollment are expected by the end of the first quarter of 2027. An independent DSMB separately conducts pre-specified periodic reviews that address safety only.
About EscharEx®
EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation tissue formation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLU) is underway, with additional clinical studies planned in diabetic foot ulcers (DFU) and pressure ulcers (PU). EscharEx has demonstrated advantages over standard-of-care treatments, including the leading enzymatic debridement agent, and targets a substantial global market opportunity.
About MediWound Ltd.
MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics for tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets. MediWound’s late-stage development candidate, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with the potential to become a new standard of care in wound management.
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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, outcome of future periodic DSMB’s reviews, 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 FDA, 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; our contracts with governmental agencies; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; 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; geopolitical risks, including armed conflict, the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on 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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026 and 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 does not undertake, 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.
| MediWound Contacts: | |||
| Hani Luxenburg Chief Financial Officer MediWound Ltd. ir@mediwound.com | Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com |
