Anacaulase-bcdb

Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment completion remain on track for end of the first quarter of 2027 YAVNE, Israel, September 14, 2026 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the independent Data and Safety Monitoring Board (DSMB) completed its pre-specified periodic safety review of the ongoing Phase III VALUE study evaluating the safety and efficacy of EscharEx® in patients with venous leg ulcers (VLU). Following its review, the DSMB did not identify any safety concerns and recommended that the study continue as planned without modification. MediWound also continues to expect the study’s pre-specified interim sample-size reassessment and completion of patient enrollment by the end of the first quarter of 2027. “We are encouraged by the DSMB’s recommendation to continue the VALUE study as planned and without modification,” said Ofer Gonen, Chief Executive Officer of MediWound. “The DSMB’s findings are consistent with the favorable safety profile observed across the EscharEx clinical program and support our continued execution of this pivotal Phase III study.” About the VALUE Trial VALUE (NCT06568627) is a global, multicenter, randomized, double-blind, placebo-controlled Phase III pivotal trial evaluating the efficacy and safety of EscharEx® in patients with venous leg ulcers (VLU). The study is designed to enroll 216 patients across approximately 40 sites in the U.S., Europe, and Israel, randomized in a 1:1 ratio to receive EscharEx or placebo. The co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure. The study includes a pre-specified interim sample-size reassessment after 65% of patients have completed the 12-week wound-management period. The interim reassessment and completion of enrollment are expected by the end of the first quarter of 2027. An independent DSMB separately conducts pre-specified periodic reviews that address safety only. About EscharEx® EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation tissue formation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLU) is underway, with additional clinical studies planned in diabetic foot ulcers (DFU) and pressure ulcers (PU). EscharEx has demonstrated advantages over standard-of-care treatments, including the leading enzymatic debridement agent, and targets a substantial global market opportunity. About MediWound Ltd. MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics for tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets. MediWound’s late-stage development candidate, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with the potential to become a new standard of care in wound management. For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter). 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, outcome of future periodic DSMB’s reviews, 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; our contracts with governmental agencies; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; 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; geopolitical risks, including armed conflict, 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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026 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 does not undertake, 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 LuxenburgChief Financial OfficerMediWound Ltd.ir@mediwound.com Daniel FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com

*题图仅做示意用 9月4日，FDA发布信息征集（RFI）公告，面向研究者、临床医生和企业征集意见，旨在加速植物药（BDP）的开发和审评。 FDA称，“鉴于消费者广泛使用植物疗法自我治疗”，拟寻求促进对植物药的研究和开发；但植物药“固有的异质性”带来一系列独特挑战。 由政治推动，但植物药行业有望获益 这份公告的出台适逢“让美国再次健康”（MAHA）运动推动替代医学（alternative medicine）升温的政治环境，尤其是对于含致幻剂和大麻等成分的药物。例如特朗普今年4月发布行政令指示FDA优先授予用于治疗严重精神疾病的致幻剂突破性疗法认定，以及美国缉毒局（DEA）于同期决定对部分大麻产品重新列管。尽管迄今获FDA放行的少数大麻类药物均为合成衍生物，但部分企业管线中的候选产品正准备走植物药路径。 FDA代理局长Kyle Diamantas在声明中明确将此举置于当前政治环境中：“在特朗普政府领导下，我们致力于现代化监管框架，以确保有前景的天然健康选择能够通过严格的科学进行评估。” 在此背景下，FDA推动植物药研究，一方面与行政当局的政策取向形成呼应；另一方面也预示其他类型的植物药开发可能迎来更多监管支持。 FDA关心哪些问题？ 植物药由多组分混合物构成，难以像化学药那样以单一单体分子表征，这给传统药品审评框架带来根本性挑战。此前FDA与Reagan-Udall基金会组织了针对性的植物药专家讨论会。会议总结指出：“植物药指南在具体应用中的执行不一致，且未充分考虑植物药的多组分性质”；“监管可预测性和一致性的缺乏直接抑制了产品开发和外部投资。”与会者还建议FDA与植物药开发者之间应增加互动，讨论试验设计的适当性、对变异的容忍度以及传统监管要求中可优化的领域。 FDA植物药审评团队基于多年审评经验中总结称“确保植物药批次之间的治疗一致性”是关键问题，而“治疗一致性通常可以通过‘证据总体’方法来支持”。所谓证据总体，包括植物原材料控制（如农业和采集规范）、基于化学检验和生产控制（包括分析检验和工艺验证）实施的质量控制，以及反映药物作用机制的生物测定和临床数据。 围绕这些难题，FDA从三个方面征求业界意见建议：研究和开发经验（包括如何使用现有FDA资源）；一般性挑战（科学与经济层面，以及不同纯化程度产品的差异）；一般性机会，其中包括“哪些研究设计最适合复杂的植物药混合物，应如何评估（例如在安全性、有效性和质量方面）”，以及在FDA之外开展质量标准开发的机会——包括公认科学知识或真实世界证据能否促进“具有成熟使用经验的植物药”的开发。 FDA还计划与经验相对更为丰富的EMA讨论草药和植物药监管考量召开联合研讨会，定于9月25日举行。 早有专门团队和指南，但仅批准4个处方植物药 FDA迄今仅批准四个处方植物药，但其构建植物药审评框架已持续二十余年：药品审评与研究中心（CDER）在2000年发布专门指南草案后，于2003年设立植物药审评团队；指南于2004年首次定稿，2015年修订，2016年12月再次定稿。 四个已获批品种包括： Veregen（sinecatechins，绿茶提取物）：2006年10月31日获批，是首个植物药新药申请（NDA），用于外生殖器和肛周疣的局部治疗。 Fulyzaq/Mytesi（crofelemer，亚马逊龙血树树皮乳液提取物）：2012年获批，用于接受抗逆转录病毒治疗的HIV/艾滋病成人非感染性腹泻的对症治疗。 NexoBrid（anacaulase-bcdb，菠萝茎菠萝蛋白酶浓缩物）：2022年12月29日获批，用于成人深二度或三度热烧伤的清创，2024年8月15日又获批儿科适应症。 Filsuvez（白桦三萜）：2023年12月18日获批，用于营养不良型和交界型大疱性表皮松解症相关伤口。 如今随着大麻来源植物药管线追求上市，以及政治层面的明确支持，这套运转二十年的审评框架能否承载新一轮植物药开发热潮，FDA将通过这份RFI寻求答案。