MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg Ulcers
MediWound (MDWD) has launched VALUE, a global Phase III pivotal trial for EscharEx® in treating venous leg ulcers (VLUs). The trial will evaluate the drug's efficacy and safety across 40 sites in the U.S. and Europe, enrolling 216 patients in a randomized, double-blind, placebo-controlled study.
The study will assess EscharEx's ability to achieve complete debridement and wound closure. Patients will receive up to eight daily applications over two weeks, followed by ten weeks of wound management. An interim analysis is expected in mid-2026 after 65% of patients complete treatment.
MediWound has established collaborations with Solventum, Mölnlycke, and MIMEDX to support the trial. The company also plans to initiate a head-to-head Phase II study comparing EscharEx to collagenase in 2025, and a Phase II/III trial for diabetic foot ulcers in 2026.
MediWound (MDWD) ha lanciato VALUE, uno studio pivotale di fase III globale per EscharEx® nel trattamento delle ulcere venose degli arti inferiori (VLU). Lo studio valuterà l'efficacia e la sicurezza del farmaco in 40 siti negli Stati Uniti e in Europa, arruolando 216 pazienti in uno studio randomizzato, in doppio cieco e controllato con placebo.
Lo studio valuterà la capacità di EscharEx di ottenere una completa detersione e chiusura della ferita. I pazienti riceveranno fino a otto applicazioni giornaliere per due settimane, seguite da dieci settimane di gestione della ferita. Un'analisi intermedia è prevista per metà 2026, dopo che il 65% dei pazienti avrà completato il trattamento.
MediWound ha stabilito collaborazioni con Solventum, Mölnlycke e MIMEDX per supportare lo studio. L'azienda prevede inoltre di avviare uno studio di fase II comparativo tra EscharEx e collagenasi nel 2025, e uno studio di fase II/III per le ulcere del piede diabetico nel 2026.
MediWound (MDWD) ha lanzado VALUE, un ensayo pivotal global de fase III para EscharEx® en el tratamiento de las úlceras venosas de las piernas (VLU). El ensayo evaluará la eficacia y seguridad del fármaco en 40 sitios en EE. UU. y Europa, reclutando a 216 pacientes en un estudio aleatorizado, doble ciego y controlado con placebo.
El estudio evaluará la capacidad de EscharEx para lograr una desbridación completa y el cierre de la herida. Los pacientes recibirán hasta ocho aplicaciones diarias durante dos semanas, seguidas de diez semanas de manejo de la herida. Se espera un análisis intermedio a mediados de 2026, después de que el 65% de los pacientes complete el tratamiento.
MediWound ha establecido colaboraciones con Solventum, Mölnlycke y MIMEDX para apoyar el ensayo. La empresa también planea iniciar un estudio de fase II comparando EscharEx con colagenasa en 2025, y un ensayo de fase II/III para úlceras del pie diabético en 2026.
MediWound (MDWD)는 EscharEx®의 정맥성 하지 궤양(VLU) 치료를 위한 글로벌 3상 주요 시험 VALUE를 시작했습니다. 이 시험은 미국과 유럽의 40개 사이트에서 약물의 효능과 안전성을 평가하며, 216명의 환자를 무작위 이중 맹검 위약 대조 연구에 등록할 예정입니다.
이 연구는 EscharEx가 완전한 괴사 제거 및 상처 폐쇄를 달성할 수 있는 능력을 평가할 것입니다. 환자들은 2주 동안 최대 8회의 일일 적용을 받게 되며, 그 후 10주 동안 상처 관리를 받습니다. 치료를 완료한 환자의 65%가 치료를 마친 후 2026년 중반에 중간 분석이 예상됩니다.
MediWound는 시험을 지원하기 위해 Solventum, Mölnlycke 및 MIMEDX와 협력 관계를 구축했습니다. 회사는 또한 2025년에 EscharEx와 콜라겐 분해 효소를 비교하는 2상 연구를 시작할 계획이며, 2026년에는 당뇨 발 궤양에 대한 2/3상 시험을 진행할 예정입니다.
MediWound (MDWD) a lancé VALUE, un essai pivot mondial de phase III pour EscharEx® dans le traitement des ulcères veineux des jambes (VLU). L'essai évaluera l'efficacité et la sécurité du médicament dans 40 sites aux États-Unis et en Europe, en recrutant 216 patients dans une étude randomisée, en double aveugle et contrôlée par placebo.
L'étude évaluera la capacité d'EscharEx à obtenir un débridement complet et une fermeture de la plaie. Les patients recevront jusqu'à huit applications quotidiennes pendant deux semaines, suivies de dix semaines de gestion des plaies. Une analyse intermédiaire est prévue pour mi-2026, après que 65 % des patients auront terminé le traitement.
MediWound a établi des collaborations avec Solventum, Mölnlycke et MIMEDX pour soutenir l'essai. L'entreprise prévoit également de lancer une étude de phase II en tête-à-tête comparant EscharEx à la collagénase en 2025, ainsi qu'un essai de phase II/III pour les ulcères du pied diabétique en 2026.
MediWound (MDWD) hat VALUE, eine globale Phase-III-Studie für EscharEx® zur Behandlung von venösen Beingeschwüren (VLU), gestartet. Die Studie wird die Wirksamkeit und Sicherheit des Medikaments an 40 Standorten in den USA und Europa bewerten und 216 Patienten in eine randomisierte, doppelblinde, placebo-kontrollierte Studie aufnehmen.
Die Studie wird die Fähigkeit von EscharEx bewerten, eine vollständige Debridement und Wundverschluss zu erreichen. Patienten erhalten bis zu acht tägliche Anwendungen über einen Zeitraum von zwei Wochen, gefolgt von zehn Wochen Wundmanagement. Eine Zwischenanalyse wird Mitte 2026 erwartet, nachdem 65% der Patienten die Behandlung abgeschlossen haben.
MediWound hat Kooperationen mit Solventum, Mölnlycke und MIMEDX etabliert, um die Studie zu unterstützen. Das Unternehmen plant außerdem, 2025 eine Phase-II-Studie zu starten, die EscharEx mit Kollagenase vergleicht, sowie eine Phase-II/III-Studie für diabetische Fußgeschwüre im Jahr 2026.
- EscharEx targets a $375+ million market with no new FDA-approved drugs since 1965
- Strategic collaborations established with industry leaders Solventum, Mölnlycke, and MIMEDX
- Comprehensive clinical development program with multiple trials planned through 2026
- Results from the Phase III trial not expected until mid-2026
- Multiple clinical trials required before potential commercialization
- Significant competition from established market leader SANTYL®
Insights
The initiation of the VALUE Phase III trial marks a pivotal moment for MediWound's EscharEx program, targeting a market segment that has seen no innovation in nearly 60 years. The trial's sophisticated design incorporates several elements that enhance its probability of success:
- The adaptive design with interim analysis at 65% enrollment (expected mid-2026) allows for sample size adjustments, optimizing statistical power while potentially reducing time and costs
- The comprehensive endpoint structure, measuring both debridement and wound closure, addresses the full spectrum of wound healing
- The inclusion of cellular/tissue-based products (CTP) or autografts for qualified patients aligns with current best practices in wound care
Previous Phase II trials have demonstrated EscharEx's superior performance compared to SANTYL®, the current
The strategic collaborations with Solventum, Mölnlycke, and MIMEDX are particularly noteworthy, as they ensure standardized wound care protocols across trial sites and access to advanced wound care products. This approach minimizes variables that could confound trial results and strengthens the study's scientific validity.
MediWound's broader clinical development strategy, including the planned Phase II/III trial in diabetic foot ulcers (DFUs), demonstrates a systematic approach to expanding EscharEx's potential market reach. The company is effectively building a comprehensive wound care portfolio that could address multiple high-value indications in the chronic wound market.
Phase III trial to assess the efficacy and safety of EscharEx® for debridement and facilitation of active wound closure
Interim analysis planned after
Strategic research collaborations with Solventum, Mölnlycke, and MIMEDX
YAVNE, Israel, Feb. 12, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx® for the treatment of venous leg ulcers (VLUs).
“We are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,” said Ofer Gonen, Chief Executive Officer of MediWound. “With no new FDA-approved drugs in this category since 1965, EscharEx has the potential to redefine the standard of care for chronic wound debridement. EscharEx has already demonstrated its ability to effectively and rapidly debride chronic wounds in multiple Phase II trials, surpassing the current
The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the U.S. and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over two weeks, followed by ten weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks.
The study co-primary endpoints are the incidence of complete debridement and the incidence of complete wound closure. Secondary endpoints include the incidence of complete granulation tissue, time to debridement, time to complete wound closure, and changes in wound area. Safety and tolerability of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after
To support the trial, MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes.
In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025, comparing EscharEx to collagenase in VLU patients. This Phase II trial is designed to support the U.S. Biologics License Application (BLA) submission for EscharEx and strengthen MediWound’s commercialization strategy. Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026.
About Venous Leg Ulcers1
Venous leg ulcers (VLUs) affect approximately
About EscharEx
EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes, enriched with bromelain, designed for topical and easy-to-use daily applications. In three previous Phase II trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing. EscharEx is currently being investigated in a global Phase III study for the treatment of venous leg ulcers (VLUs). Preparations are underway for a Phase II/III study targeting diabetic foot ulcers (DFUs).
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx®, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the currently available
For more information visit www.mediwound.com and follow us on LinkedIn.
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 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 EscharEx, 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 EscharEx 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 EscharEx; 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 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 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 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.
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1 Primary research, Alira Health analysis (2025)
FAQ
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