MediWound to Host Virtual Key Opinion Leader Event to Discuss EscharEx® Phase III VALUE Study in Venous Leg Ulcers and Its Commercial Opportunity on January 8, 2025
MediWound (MDWD) announced a virtual Key Opinion Leader (KOL) event scheduled for January 8, 2025, at 10:00 AM ET. The event will focus on EscharEx®, their biologic drug in late-stage clinical development for chronic wound debridement, specifically discussing the upcoming Phase III VALUE study in venous leg ulcers (VLUs) and its commercial potential.
The event will feature three distinguished clinical experts from prestigious institutions who will discuss compelling Phase II study results, the Phase III VALUE study, unmet needs in VLUs and diabetic foot ulcers (DFUs) treatment, and EscharEx's competitive advantages. A Q&A session with the experts and MediWound's leadership team will follow the presentations.
MediWound (MDWD) ha annunciato un evento virtuale con i Key Opinion Leader (KOL) programmato per l'8 gennaio 2025, alle 10:00 ET. L'evento si concentrerà su EscharEx®, il loro farmaco biologico in fase avanzata di sviluppo clinico per il debridement delle ferite croniche, discutendo in particolare del prossimo studio VALORE di Fase III per le ulcere venose degli arti inferiori (VLU) e il suo potenziale commerciale.
L'evento presenterà tre esperti clinici di spicco provenienti da istituzioni prestigiose, che discuteranno dei risultati significativi dello studio di Fase II, dello studio VALORE di Fase III, dei bisogni insoddisfatti nel trattamento delle VLU e delle ulcere del piede diabetico (DFU), e dei vantaggi competitivi di EscharEx. Seguirà una sessione di domande e risposte con gli esperti e il team di leadership di MediWound.
MediWound (MDWD) anunció un evento virtual con los Líderes de Opinión Clave (KOL) programado para el 8 de enero de 2025, a las 10:00 AM ET. El evento se centrará en EscharEx®, su medicamento biológico en desarrollo clínico avanzado para el desbridamiento de heridas crónicas, discutiendo específicamente el próximo estudio VALOR de Fase III en úlceras venosas de las piernas (VLU) y su potencial comercial.
El evento contará con tres expertos clínicos destacados de instituciones prestigiosas que discutirán resultados impactantes del estudio de Fase II, el estudio VALOR de Fase III, las necesidades no satisfechas en el tratamiento de VLU y úlceras del pie diabético (DFU), y las ventajas competitivas de EscharEx. Seguirá una sesión de preguntas y respuestas con los expertos y el equipo directivo de MediWound.
MediWound (MDWD)는 2025년 1월 8일 오전 10시(ET)에 예정된 가상 키 오피니언 리더(KOL) 이벤트를 발표했습니다. 이번 이벤트는 만성 상처 제거를 위한 후기 임상 개발 단계에 있는 EscharEx®에 초점을 맞추며, 특히 정맥성 다리 궤양(VLU)에서의 3상 VALUE 연구와 상업적 잠재력에 대해 논의할 것입니다.
이 이벤트에서는 저명한 기관의 세 명의 임상 전문가가 참여하여 2상 연구 결과, 3상 VALUE 연구, VLU 및 당뇨발 궤양(DFU) 치료의 미충족 요구 사항 및 EscharEx의 경쟁 우위에 대해 논의할 것입니다. 프레젠테이션 후에는 전문가들과 MediWound의 경영진과의 질의응답 세션이 진행됩니다.
MediWound (MDWD) a annoncé un événement virtuel avec des leaders d'opinion clé (KOL) prévu pour le 8 janvier 2025 à 10h00 HE. L'événement se concentrera sur EscharEx®, leur médicament biologique en phase avancée de développement clinique pour le débridement des plaies chroniques, en particulier pour discuter de la prochaine étude VALUE de phase III sur les ulcères veineux des membres inférieurs (VLU) et son potentiel commercial.
L'événement mettra en vedette trois experts cliniques de renom issus d'institutions prestigieuses qui aborderont les résultats convaincants de l'étude de phase II, l'étude VALUE de phase III, les besoins non satisfaits dans le traitement des VLU et des ulcères du pied diabétique (DFU), ainsi que les avantages concurrentiels d'EscharEx. Une session de questions-réponses avec les experts et l'équipe de direction de MediWound suivra les présentations.
MediWound (MDWD) hat eine virtuelle Veranstaltung mit Key Opinion Leaders (KOL) angekündigt, die für den 8. Januar 2025 um 10:00 Uhr ET geplant ist. Die Veranstaltung wird sich auf EscharEx® konzentrieren, ihr biopharmazeutisches Produkt, das sich in der letzten Phase der klinischen Entwicklung für die Behandlung chronischer Wunden befindet, insbesondere auf die bevorstehende Phase-III VALUE-Studie bei venösen Beingeschwüren (VLU) und deren kommerzielles Potenzial.
Die Veranstaltung wird drei angesehene klinische Experten aus renommierten Institutionen umfassen, die über die überzeugenden Ergebnisse der Phase-II-Studie, die Phase-III VALUE-Studie, unmet Bedürfnisse in der Behandlung von VLU und diabetischen Fußgeschwüren (DFU) sowie die Wettbewerbsvorteile von EscharEx sprechen werden. Im Anschluss an die Präsentationen folgt eine Frage-und-Antwort-Runde mit den Experten und dem Führungsteam von MediWound.
- Company advancing to Phase III clinical trials for EscharEx in VLUs
- Strong expert panel participation from leading medical institutions
- Multiple potential applications including VLUs and DFUs indicating broad market opportunity
- None.
YAVNE, Israel, Dec. 17, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced it will host a virtual Key Opinion Leader (KOL) event on Wednesday, January 8, 2025, at 10:00 AM ET. The event will focus on EscharEx®, an innovative biologic drug in late-stage clinical development for chronic wound debridement, including the upcoming Phase III VALUE study in venous leg ulcers (VLUs) and EscharEx’s commercial opportunity.
The event will feature three distinguished clinical experts:
- John C. Lantis II, MD | Icahn School of Medicine at Mount Sinai
- Vickie R. Driver, DPM, MS, FACFAS, FAAWC | Washington State University
- Robert J. Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS | Barry University School of Podiatric Medicine
Discussion Topics Include:
- Compelling results to date from Phase II studies of EscharEx
- The upcoming Phase III VALUE study of EscharEx in VLUs
- The substantial unmet need and current treatment landscape for VLUs and diabetic foot ulcers (DFUs)
- EscharEx's competitive advantages and unique commercial potential
A live question and answer session with the key opinion leaders and members of MediWound's leadership team will follow the formal presentations. To register for the event, please click here.
Speaker Bios:
John C. Lantis II, MD
Dr. John C. Lantis is currently the site Chief and Professor of Surgery at Mount Sinai West Hospital, and the Icahn School of Medicine in mid-town Manhattan where he practices as a senior vascular surgeon. On January 1, 2024 he was named the Director of Advanced Wound Care, Department of surgery, Mount Sinai healthcare system. In 2023, he was named the Editor in Chief of the journal WOUNDS, a Clinical Compendium. He is the past president of the New York Vascular Surgery Society, a founding member of the American Board of Wound Medicine and Surgery, and the Vascular Study Group of New York. He is recognized as a world leader in limb salvage and lower extremity wound healing, which includes a very large breadth of knowledge regarding cellular and tissue-based therapies, negative pressure wound therapy, growth factor and stem cell therapy, and local/regional flap therapy. He has been a principal investigator on over 80 clinical trials.
Vickie R. Driver, DPM, MS, FACFAS, FAAWC
Dr. Vickie R. Driver is a Professor at Washington State University School of Medicine. She is also a Fellow of the Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow of the Association for the Advancement of Wound Care. She serves as Honorary Visiting Professor at Cardiff University (UK) in the Department of Medicine and Professor-affiliate at Barry University (USA) and received the prestigious Robert A. Warriner III, MD Memorial Award. Dr. Driver currently serves and has served in multiple key leadership positions, including as past president of the Advancement of Wound Care Association, and a Board of Directors member of the Wound Healing Society and Critical Limb Ischemia Global Society. She is the Founding Chairperson for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS, and the NIH. As lead investigator, she has served on and initiated more than 70 important multi-center randomized clinical trials, as well as developed and supervised multiple research fellowship training programs. She has co-authored well over 150 publications and abstracts and was a Director at the Translational Medicine at Novartis Institute for BioMedical Research.
Robert J. Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS
Dr. Robert J. Snyder is a distinguished Professor and serves as Dean and the Director of Clinical Research at Barry University. He is a Diplomat of the American Board of Podiatric Surgery, a fellow of the American College of Foot and Ankle Surgery and was the President of both the Association for the Advancement of Wound Care and the American Board of Wound Management. Additionally, he is an Honorary Senior Lecturer at The Centre of Medical Education at The University of Wales School of Medicine. Dr. Snyder has been principal investigator on more than 60 randomized-controlled trials regarding innovative wound healing therapies. He has published more than 165 peer-reviewed and trade journal articles, and currently serves on several editorial advisory boards. He has received numerous awards including the Robert A. Warriner III, MD Memorial Award for Excellence in Wound Management and the SAWC Founders Award for his work in wound management education and research. Dr. Snyder was recently inducted as a Faculty Fellow in Podiatric Medicine, Royal College of Physicians and Surgeons (Glasgow).
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 Phase III study for venous leg ulcers (VLUs) imminently. Preparations for a Phase II/III study targeting diabetic foot ulcers (DFUs) 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 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 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 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 EscharEx; our expectations regarding future growth; 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 EscharEx 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 | Daniel Ferry |
| Chief Financial Officer | Managing Director |
| MediWound Ltd. | LifeSci Advisors, LLC |
| ir@mediwound.com | daniel@lifesciadvisors.com |
| Media Contact: | |
| Ellie Hanson | |
| FINN Partners for MediWound | |
| ellie.hanson@finnpartners.com | |
| +1-929-588-2008 |
FAQ
When is MediWound (MDWD) hosting its KOL event for EscharEx Phase III study?
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