MediWound Announces Phase II Head-to-Head Study Evaluating EscharEx® vs. Collagenase in Patients with Venous Leg Ulcers
MediWound (Nasdaq: MDWD) has announced the initiation of a Phase II clinical study comparing EscharEx® to collagenase ointment for treating venous leg ulcers (VLUs). The study, set to begin in 2025, will run alongside the company's Phase III trial and aims to support the Biologics License Application (BLA) for EscharEx while strengthening MediWound's commercialization strategy.
The randomized study will enroll 45 patients across multiple sites in the U.S. and Europe, evaluating safety endpoints and exploratory efficacy measures. MediWound has secured R&D collaborations with Solventum and Mölnlycke Health Care to provide compression systems and wound care products, ensuring consistency and optimal patient outcomes across study arms.
MediWound (Nasdaq: MDWD) ha annunciato l'inizio di uno studio clinico di Fase II che confronterà EscharEx® con un'unguento a base di collagene per il trattamento delle ulcere venose agli arti inferiori (VLU). Lo studio, che inizierà nel 2025, si svolgerà parallelamente al trial di Fase III dell'azienda e mira a supportare la Domanda di Licenza Biologica (BLA) per EscharEx, rafforzando nel contempo la strategia di commercializzazione di MediWound.
Lo studio randomizzato recluterà 45 pazienti in diversi siti negli Stati Uniti e in Europa, valutando gli endpoint di sicurezza e le misure di efficacia esplorativa. MediWound ha assicurato collaborazioni nella ricerca e sviluppo con Solventum e Mölnlycke Health Care per fornire sistemi di compressione e prodotti per la cura delle ferite, garantendo coerenza e risultati ottimali per i pazienti nei vari gruppi di studio.
MediWound (Nasdaq: MDWD) ha anunciado el inicio de un estudio clínico de Fase II que comparará EscharEx® con un ungüento de colagenasa para el tratamiento de úlceras venosas en las piernas (VLU). El estudio, que comenzará en 2025, se llevará a cabo junto con el ensayo de Fase III de la empresa y tiene como objetivo apoyar la Solicitud de Licencia Biológica (BLA) para EscharEx, al tiempo que fortalece la estrategia de comercialización de MediWound.
El estudio aleatorizado inscribirá a 45 pacientes en múltiples sitios en EE. UU. y Europa, evaluando los puntos finales de seguridad y las medidas de eficacia exploratoria. MediWound ha asegurado colaboraciones en I+D con Solventum y Mölnlycke Health Care para proporcionar sistemas de compresión y productos de cuidado de heridas, asegurando consistencia y resultados óptimos para los pacientes en los diferentes grupos de estudio.
MediWound (Nasdaq: MDWD)가 EscharEx®와 콜라게나제 연고를 비교하는 2상 임상 연구의 시작을 발표했습니다. 이 연구는 2025년에 시작될 예정이며, 회사의 3상 시험과 함께 진행되어 EscharEx에 대한 생물학적 제품 라이센스 신청(BLA)을 지원하고 MediWound의 상업화 전략을 강화하는 것을 목표로 합니다.
무작위 연구는 미국과 유럽의 여러 장소에서 45명의 환자를 모집하고 안전성 지표와 탐색적 유효성을 평가합니다. MediWound는 압박 시스템과 상처 치료 제품을 제공하기 위해 Solventum 및 Mölnlycke Health Care와 연구 및 개발 협력을 확보하여 연구 그룹 간 일관성 및 최적의 환자 결과를 보장하고 있습니다.
MediWound (Nasdaq: MDWD) a annoncé le lancement d'une étude clinique de Phase II comparant EscharEx® à une pommade à la collagenase pour le traitement des ulcères veineux des jambes (VLU). L'étude, qui doit débuter en 2025, se déroulera parallèlement à l'essai de Phase III de l'entreprise et vise à soutenir la Demande de Licence Biologique (BLA) pour EscharEx tout en renforçant la stratégie de commercialisation de MediWound.
L'étude randomisée recrutera 45 patients dans plusieurs sites aux États-Unis et en Europe, évaluant les critères de sécurité et les mesures d'efficacité exploratoires. MediWound a sécurisé des collaborations R&D avec Solventum et Mölnlycke Health Care pour fournir des systèmes de compression et des produits de soin des plaies, garantissant ainsi constance et résultats optimaux pour les patients dans les bras de l'étude.
MediWound (Nasdaq: MDWD) hat den Beginn einer Klinischen Studie der Phase II angekündigt, die EscharEx® mit einer Kollagenase-Salbe zum Zweck der Behandlung von venösen Beingeschwüren (VLU) vergleicht. Die Studie, die 2025 beginnen soll, wird parallel zur Phase-III-Studie des Unternehmens durchgeführt und zielt darauf ab, den Biologics License Application (BLA) für EscharEx zu unterstützen, während sie die Vermarktungsstrategie von MediWound stärkt.
In der randomisierten Studie werden 45 Patienten an mehreren Standorten in den USA und Europa rekrutiert, wobei Sicherheitsendpunkte und explorative Wirksamkeitsmaßnahmen bewertet werden. MediWound hat F&E-Kooperationen mit Solventum und Mölnlycke Health Care gesichert, um Kompressionssysteme und Wundversorgung Produkte bereitzustellen und so Konsistenz und optimale Patientenergebnisse in den Studienarmen zu gewährleisten.
- Phase II study to compare EscharEx® against collagenase ointment for VLU treatment
- Study designed to support Biologics License Application (BLA) for EscharEx®
- Strategic R&D collaborations formed with Solventum and Mölnlycke Health Care
- Concurrent execution with ongoing Phase III trial in VLU patients
- None.
Insights
This Phase II head-to-head study comparing EscharEx® to collagenase for venous leg ulcers (VLUs) is a strategic move by MediWound. The study aims to support the Biologics License Application (BLA) for EscharEx® and strengthen its commercialization strategy, which could significantly impact the company's future market position.
Key points to consider:
- The study builds on positive results from three prior Phase II studies, potentially validating EscharEx®'s superiority over SANTYL® (collagenase) on a larger, global scale.
- Running concurrently with a Phase III trial, this study could accelerate the path to market if results are positive.
- Collaborations with Solventum and Mölnlycke for wound care products may enhance trial consistency and outcomes, potentially improving the study's credibility.
- The 45-patient enrollment across multiple sites in the U.S. and Europe suggests a well-designed, though relatively small, study.
While promising, investors should note that positive Phase II results don't guarantee success in larger trials or regulatory approval. The 2025 study start date indicates a longer-term horizon for potential market impact.
Secured additional R&D collaborations with Solventum and Mölnlycke for optimal trial consistency and patient outcomes
Study to support EscharEx® BLA submission and strengthen commercialization strategy
YAVNE, Israel, Oct. 10, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that it will be initiating a controlled, multicenter Phase II clinical study evaluating EscharEx® against collagenase ointment (marketed as SANTYL® in the U.S. and IRUXOL® in Europe) for the treatment of venous leg ulcers (VLUs). Scheduled to commence in 2025, this Phase II study will run concurrently with the Company’s Phase III trial in VLU patients. The study is designed to support the Biologics License Application (BLA) for EscharEx and plays a key role in MediWound’s commercialization strategy.
Ofer Gonen, CEO of MediWound, stated: "Building on the consistent positive results from three prior Phase II studies of EscharEx, we are eager to further validate our earlier findings from the head-to-head comparison vs. SANTYL, now on a larger, global scale. We are confident that EscharEx will demonstrate superior efficacy, addressing critical unmet needs in enzymatic debridement for patients with chronic wounds."
The randomized, prospective study will enroll 45 patients across multiple sites in the U.S. and Europe. VLU patients will be randomly assigned in a 1:1:1 ratio to receive either EscharEx, placebo, or collagenase. In the first two weeks, the EscharEx and placebo groups will receive up to 8 daily applications, while the collagenase group will follow the product’s instructions for use (IFU). Each patient’s participation will last up to 14 weeks. Key safety endpoints, including the incidence and severity of adverse events (AEs), and time to complete wound closure, will be assessed. Additionally, exploratory efficacy endpoints will evaluate the incidence and time to complete debridement, granulation tissue formation, and wound bed preparation.
To support this trial, MediWound has formed additional strategic R&D collaborations with Solventum and Mölnlycke Health Care. Solventum will supply the Coban™ 2 Two-Layer Compression System, while Mölnlycke will provide Mepilex®, Mepilex® Ag, Exufiber®, and Exufiber® Ag. These partnerships are designed to enhance consistency across study arms and ensure the use of best-in-class products, ultimately benefiting patient outcomes.
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. MediWound is set to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024. Preparations for a Phase II/III study targeting Diabetic Foot Ulcers are underway.
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 rapid and effective biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is FDA and EMA-approved as an orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions. Building on its proprietary enzymatic platform, MediWound is advancing EscharEx®, a promising candidate currently in Phase III development for the debridement of chronic wounds. With distinct advantages over the current
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 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; 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 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.
| MediWound Contacts: Hani Luxenburg Chief Financial Officer MediWound Ltd. ir@mediwound.com | Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com |
| Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com +1-929-588-2008 |
FAQ
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