{"id":57724,"date":"2024-07-29T12:03:50","date_gmt":"2024-07-29T12:03:50","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/07\/29\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/"},"modified":"2024-07-29T12:03:50","modified_gmt":"2024-07-29T12:03:50","slug":"mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/","title":{"rendered":"MediWound Announces Publication of the EscharEx\u00ae Phase II ChronEx Study Results for Venous Leg Ulcers"},"content":{"rendered":"<div>\n<p align=\"center\"><em>Research Published in THE LANCET&#8217;s eClinicalMedicine<br \/><\/em><em>EscharEx<\/em><sup><em>\u00ae<\/em><\/sup><em> Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue<\/em><\/p>\n<p align=\"justify\">YAVNE, Israel, July  29, 2024  (GLOBE NEWSWIRE) &#8212; MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rkbDHM4MEzdrcnomm966J3t9KTqMcg_KQVFghCQfCsHer9lLhY6iOMhcODxFOfCAgXbqCWywd4pLKW4R00S6YvODjyeqNxL5Iqe-4z5YrKdePNy9MU_EHVHer6FSrBiO\" rel=\"nofollow noopener\" target=\"_blank\" title=\"THE LANCET Discovery Science\">THE LANCET Discovery Science<\/a> umbrella. The publication, titled &#8220;<em>Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study<\/em>&#8220;, reports the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=caUVCaSLRovkyIwZXgOowaJGuqxaWtxwuLG_ebE-2DV6LY86uHnLqtULT9rF_1bHnswzpNTfHu3b24P4yEZUgbagvE-RXs5TSfKfs0qyF5FGQdqP18kCnZOHyMzpMO6qWp4QaQR25YAJbxSZjb4oNJWmrqQbmjSSQR92Szs7vX0=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>results of the study<\/u><\/a>.<\/p>\n<p align=\"justify\">\u201cThe publication in eClinicalMedicine highlights the importance of a safe and effective non-surgical treatment for debridement of chronic wounds, particularly venous leg ulcers (VLUs). Removing non-viable tissue and promoting well-vascularized granulation tissue are essential steps in wound bed preparation, which is crucial for successful wound healing,\u201d stated Dr. John C. Lantis, Chief of Surgery at Mount Sinai West Hospital and principal investigator in the ChronEx study. \u201cThe significant superiority of EscharEx over the current non-surgical standard of care in achieving optimal wound bed preparation could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. This will be a primary focus of the upcoming EscharEx Phase III trial in treating VLUs.\u201d<\/p>\n<p align=\"justify\">The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL<sup>\u00ae<\/sup>, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks.<\/p>\n<p align=\"justify\">Key study outcomes include:<\/p>\n<ul type=\"disc\">\n<li style=\"text-align:justify;\">A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm.<\/li>\n<li style=\"text-align:justify;\">Baseline characteristics of patients and wounds were comparable across all study arms.<\/li>\n<li style=\"text-align:justify;\">The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P &lt; 0.001).<\/li>\n<li style=\"text-align:justify;\">The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016).<\/li>\n<li style=\"text-align:justify;\">The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P &lt; 0.001).<\/li>\n<li style=\"text-align:justify;\">Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms.<\/li>\n<li style=\"margin-top:5pt; margin-bottom:5pt; text-align:justify;\">The safety profile of EscharEx was comparable to both NSSOC and the placebo.<\/li>\n<\/ul>\n<p align=\"justify\"><strong>About EscharEx<\/strong><\/p>\n<p align=\"justify\">EscharEx<sup>\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 for topical, easy to use daily applications. In several 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, and a Phase II\/III study targeting Diabetic Foot Ulcers in the second half of 2025.<\/p>\n<p align=\"justify\"><strong>About\u00a0MediWound <\/strong><\/p>\n<p align=\"justify\">MediWound Ltd. (Nasdaq: MDWD) is the 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 improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.<\/p>\n<p align=\"justify\">MediWound\u2019s first drug, NexoBrid<sup>\u00ae<\/sup>, is an FDA and EMA-approved orphan biologic for eschar removal in deep partial-thickness and\/or full-thickness thermal burns, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&amp;D pipeline, including the company\u2019s lead drug under development, EscharEx<sup>\u00ae<\/sup>. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market.<\/p>\n<p align=\"justify\">For more information visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=NGLudY_wxxcJfKrQyGZAayxNE1WVQBPCYHTddRNK7mIfffESSkbM2ry4YCFOri6m0M4TfAU2-clImtlGMy4DUAsFrVba0D8P2d9f7F9Sbao=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>www.mediwound.com<\/u><\/a> and follow the Company on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=WGWBWrstZ3Kc_WszkRZhcWkEld5wg5FvfD4191Mx1Q4_qy-aUxAqSuz4GFt3bOddtE4Ef2UtiSK6YF_6-S3rkAaZFQwSFBb7sP-JhF_iYtw=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>LinkedIn<\/u><\/a>.<\/p>\n<p align=\"justify\"><strong>Cautionary Note Regarding Forward-Looking Statements<\/strong><\/p>\n<p align=\"justify\"><em>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.\u00a0 Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.\u00a0 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<\/em>. <em>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 our products and product candidates, including\u00a0EscharEx<\/em><sup><em>\u00ae<\/em><\/sup><em>. 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<\/em><em>. <\/em><em>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.<\/em><\/p>\n<table style=\"border-collapse: collapse; width:1196.81px; border-collapse:collapse ;\">\n<tr>\n<td style=\"max-width:60%; width:718.078px; min-width:60%;\"><strong>MediWound Contacts:<\/strong><\/td>\n<td style=\"max-width:40%; width:478.734px; min-width:40%;\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td>Hani Luxenburg<\/td>\n<td>Daniel Ferry<\/td>\n<\/tr>\n<tr>\n<td>Chief Financial Officer<\/td>\n<td>Managing Director<\/td>\n<\/tr>\n<tr>\n<td>MediWound Ltd.<\/td>\n<td>LifeSci Advisors, LLC<\/td>\n<\/tr>\n<tr>\n<td><a href=\"mailto:ir@mediwound.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>ir@mediwound.com<\/u><\/a><\/td>\n<td><a href=\"mailto:daniel@lifesciadvisors.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>daniel@lifesciadvisors.com<\/u><\/a><\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td><strong>Media Contact:<\/strong><\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>Ellie Hanson<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>FINN Partners for MediWound<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td><a href=\"mailto:ellie.hanson@finnpartners.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>ellie.hanson@finnpartners.com<\/u><\/a><\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>+1-929-588-2008<\/td>\n<\/tr>\n<\/table>\n<p><img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MDg4YWY1ZTQtNWVkOS00MTQ1LWFiMGEtNGE5OWU3ODQ3MjA4LTEwMjg0MzQ=\/tiny\/MediWound-Ltd-.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Research Published in THE LANCET&#8217;s eClinicalMedicineEscharEx\u00ae Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) &#8212; MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety [&#8230;]\n","protected":false},"author":1,"featured_media":57725,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-57724","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MediWound Announces Publication of the EscharEx\u00ae Phase II ChronEx Study Results for Venous Leg Ulcers - Biz and Live in Saigon<\/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:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-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 Announces Publication of the EscharEx\u00ae Phase II ChronEx Study Results for Venous Leg Ulcers\" \/>\n<meta property=\"og:description\" content=\"Research Published in THE LANCET&#8217;s eClinicalMedicineEscharEx\u00ae Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-29T12:03:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/english.saigonbiz.com\/vn\/wp-content\/uploads\/2024\/07\/MediWound-Ltd-.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1\" \/>\n\t<meta property=\"og:image:height\" content=\"1\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"MediWound Announces Publication of the EscharEx\u00ae Phase II ChronEx Study Results for Venous Leg Ulcers\",\"datePublished\":\"2024-07-29T12:03:50+00:00\",\"dateModified\":\"2024-07-29T12:03:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/\"},\"wordCount\":1276,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"Pr Newswire\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/mediwound-announces-publication-of-the-escharex-phase-ii-chronex-study-results-for-venous-leg-ulcers\/\",\"name\":\"MediWound Announces Publication of the EscharEx\u00ae Phase II ChronEx Study Results for Venous Leg Ulcers - 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