{"id":811945,"date":"2025-02-12T07:06:03","date_gmt":"2025-02-12T12:06:03","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/"},"modified":"2025-02-12T07:06:03","modified_gmt":"2025-02-12T12:06:03","slug":"mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/","title":{"rendered":"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers"},"content":{"rendered":"
\n

\n Phase III trial to assess the efficacy and safety of EscharEx<\/em>
\n
\n \u00ae<\/em>
\n <\/sup>
\n for debridement and facilitation of active wound closure<\/em>\n <\/p>\n

\n Interim analysis planned after 65% of patients complete treatment, expected in mid-2026<\/em><\/em>\n <\/p>\n

\n Strategic research collaborations with Solventum, M\u00f6lnlycke, and MIMEDX<\/em>\n <\/p>\n

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\u00ae<\/sup> for the treatment of venous leg ulcers (VLUs).<\/p>\n

\u201cWe are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,\u201d said Ofer Gonen, Chief Executive Officer of MediWound. \u201cWith 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 $375+ million market leader in wound debridement, SANTYL\u00ae<\/sup>. We are confident that EscharEx will provide meaningful benefits to patients, healthcare providers, and payors alike.\u201d<\/p>\n

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\u2014defined as complete debridement and full coverage with granulation tissue\u2014will receive a cellular\/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks.<\/p>\n

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 65% of patients complete treatments, enabling adaptive adjustments as needed.\u00a0This interim analysis is expected in mid-2026. <\/p>\n

To support the trial, MediWound has established strategic research collaborations with Solventum, M\u00f6lnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes.<\/p>\n

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\u2019s 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.<\/p>\n

\n About Venous Leg Ulcers<\/strong>
\n
\n 1<\/strong>
\n <\/sup>\n <\/p>\n

Venous leg ulcers (VLUs) affect approximately 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S. These ulcers typically develop on the lower extremities due to chronic venous insufficiency. VLUs are characterized by large, shallow wounds that can cause severe pain, infection, and disability, highlighting the urgent need for effective treatment options. Debridement, a critical first step in managing these wounds, is performed in 68% of cases and is commonly achieved through enzymatic methods like SANTYL\u00ae<\/sup>, autolytic debridement, or sharp debridement.<\/p>\n

\n About EscharEx <\/strong>\n <\/p>\n

EscharEx\u00ae<\/sup> 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).<\/p>\n

\n About MediWound <\/strong>\n <\/p>\n

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.<\/p>\n

MediWound\u2019s first drug, NexoBrid\u00ae<\/sup>, 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\u00ae<\/sup>, 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 $375+ million drug for wound debridement, presenting a unique opportunity for significant market growth.<\/p>\n

For more information visit www.mediwound.com<\/u><\/a> and follow us on LinkedIn<\/u><\/a>.<\/strong><\/p>\n

\n Cautionary Note Regarding Forward-Looking Statements<\/strong>\n <\/p>\n

MediWound\u00a0cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect,\u00a0believe,\u00a0or anticipate will or may occur in the future are forward-looking statements.\u00a0Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current\u00a0expectations about future events affecting us and are subject to risks, assumptions,\u00a0uncertainties,\u00a0and 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 \u201canticipates,\u201d \u201cintends,\u201d \u201cestimates,\u201d \u201cplans,\u201d \u201cexpects,\u201d \u201ccontinues,\u201d \u201cbelieve,\u201d \u201cguidance,\u201d \u201coutlook,\u201d \u201ctarget,\u201d \u201cfuture,\u201d \u201cpotential,\u201d \u201cgoals\u201d and similar words or phrases, or future or conditional verbs such as \u201cwill,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201cmay,\u201d or similar expressions.<\/p>\n

Specifically, this press release contains forward-looking statements concerning\u00a0the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of EscharEx\u00ae<\/sup>. 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.<\/p>\n

These and other significant factors are discussed in greater detail in MediWound\u2019s annual report on Form 20-F for the year ended\u00a0December 31, 2023, filed with the\u00a0Securities and Exchange Commission\u00a0(\u201cSEC\u201d) on\u00a0March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the\u00a0SEC\u00a0from time-to-time. These forward-looking statements reflect MediWound\u2019s current views as of the date hereof and\u00a0MediWound\u00a0undertakes, 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.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n MediWound Contacts:<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
Hani Luxenburg<\/td>\nDaniel Ferry<\/td>\n<\/tr>\n
Chief Financial Officer<\/td>\nManaging Director<\/td>\n<\/tr>\n
MediWound Ltd.<\/td>\nLifeSci Advisors, LLC<\/td>\n<\/tr>\n
\n ir@mediwound.com<\/a>\n <\/td>\n\n daniel@lifesciadvisors.com<\/a>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Media Contact:<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
Ellie Hanson<\/td>\n\u00a0<\/td>\n<\/tr>\n
FINN Partners for MediWound<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n ellie.hanson@finnpartners.com<\/a>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
+1-929-588-2008<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

\n 1<\/sup> Primary research, Alira Health analysis (2025)<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Phase III trial to assess the efficacy and safety of EscharEx \u00ae for debridement and facilitation of active wound closure Interim analysis planned after 65% of patients complete treatment, expected in mid-2026 Strategic research collaborations with Solventum, M\u00f6lnlycke, 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\u00ae for the treatment of venous leg ulcers (VLUs). \u201cWe are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,\u201d said Ofer Gonen, Chief Executive Officer of MediWound. \u201cWith no new FDA-approved drugs in this category since 1965, EscharEx … <\/p>\n

Continue reading “MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-811945","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nMediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Phase III trial to assess the efficacy and safety of EscharEx \u00ae for debridement and facilitation of active wound closure Interim analysis planned after 65% of patients complete treatment, expected in mid-2026 Strategic research collaborations with Solventum, M\u00f6lnlycke, 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\u00ae for the treatment of venous leg ulcers (VLUs). \u201cWe are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,\u201d said Ofer Gonen, Chief Executive Officer of MediWound. \u201cWith no new FDA-approved drugs in this category since 1965, EscharEx … Continue reading "MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-12T12:06:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM1NjY1NyM2NzQ1OTI0IzIwMTY4NjE=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers\",\"datePublished\":\"2025-02-12T12:06:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/\"},\"wordCount\":1364,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTM1NjY1NyM2NzQ1OTI0IzIwMTY4NjE=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\\\/\",\"name\":\"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers - 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(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\u00ae for the treatment of venous leg ulcers (VLUs). \u201cWe are proud to initiate the VALUE study, the most comprehensive VLU trial in over a decade,\u201d said Ofer Gonen, Chief Executive Officer of MediWound. \u201cWith no new FDA-approved drugs in this category since 1965, EscharEx … Continue reading \"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/","og_site_name":"Market Newsdesk","article_published_time":"2025-02-12T12:06:03+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM1NjY1NyM2NzQ1OTI0IzIwMTY4NjE=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers","datePublished":"2025-02-12T12:06:03+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/"},"wordCount":1364,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM1NjY1NyM2NzQ1OTI0IzIwMTY4NjE=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-leg-ulcers\/","name":"MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx\u00ae for Treatment of Venous Leg Ulcers - 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