Vancomycin Hydrochloride

TORONTO, July 22, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the investigator-led Phase II trial titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTIAK) has commenced patient recruitment at its primary clinical sites in Alberta, Canada. The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with nephrotoxic pharmaceuticals, which include commonly used drugs such as antibiotics, chemotherapy agents, and imaging dyes, some of which are known to cause kidney damage as a side effect. The trial plans to enrol approximately 698 patients in five hospital sites in Alberta. The PONTIAK clinical team, based at the Universities of Calgary and Alberta, secured $1.5 million in funding for the Phase II trial from the Canadian Institutes of Health Research (CIHR), along with $400,000 under the Accelerating Clinical Trials (ACT) initiative aimed at evaluating Canadian biotechnologies using randomized controlled trials. Arch Biopartners recently manufactured the first-ever, stand-alone cilastatin drug product and has provided the drug supply for the trial. While the trial is investigator-led and independently funded, the Company is also evaluating opportunities to support a complementary arm of the study in another jurisdiction, such as the United States under an application to the U.S. Food and Drug Administration. Quote from Richard Muruve, CEO, Arch Biopartners: “Congratulations to the PONTIAK team for achieving this milestone and beginning patient enrolment. This marks an important advancement in evaluating cilastatin as a potential first-in-class treatment to prevent AKI caused by exogenous toxins from several commonly used pharmaceutical products.” About AKI AKI reflects a broad spectrum of clinical presentations, ranging from mild injury to severe injury that may result in permanent and complete loss of renal function. Clinically, the causes of AKI include sepsis, ischemia-reperfusion injury, and various endogenous as well as exogenous (drug) toxins. There is no specific therapeutic treatment available on the market that prevents AKI. In the worst cases, the kidneys fail, requiring dialysis or kidney transplantation for patient survival. Drug toxins cause approximately 30% of AKI cases in hospitalized patients and include a wide range of pharmaceutical drugs such as antibiotics (vancomycin, aminoglycosides), chemotherapeutic agents, and radiographic contrast. Additionally, AKI related to cardiac surgery (CS-AKI) accounts for up to 20% of in-hospital AKI cases. About Cilastatin Cilastatin was originally developed in the early 1980s by Merck Sharp & Dohme Research Laboratories to limit the role of dipeptidase-1 (DPEP1) in the breakdown of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as a fixed combination with imipenem to treat different types of bacterial infections. This fixed combination, approved by the FDA in 1985, is currently marketed under different names, including Primaxin® (USA, UK, Australia, Italy), Tienam® (Spain, Belgium), or Zienam® (Germany). Composition of matter patents for imipenem and cilastatin have expired, and the combination drug is currently in a generic phase. There is no commercial history of cilastatin as a stand-alone drug product. Cilastatin has a slightly different mechanism of action compared with Arch’s novel drug candidate, LSALT peptide (Metablok), a non-enzymatic DPEP1 inhibitor. Whereas LSALT peptide specifically blocks DPEP1-mediated inflammation in the kidney, lungs, and liver, cilastatin has off-target effects that prevent toxin uptake in the kidneys. As such, cilastatin is particularly effective for toxin-related AKI. Arch Biopartners owns and has exclusively licensed method-of-use patents to repurpose cilastatin as a new treatment targeting AKI. The PONTIAK Phase II clinical trial is registered on ClinicalTrials.gov under identifier NCT06886464. About Arch Biopartners Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury and organ damage caused by inflammation. The Company is developing a platform of novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway prevalent in the kidneys, lungs, and liver. LSALT peptide and cilastatin are lead drug candidates in separate Phase II trials targeting acute kidney injury caused by inflammation and toxins, respectively. Both indications represent significant unmet medical needs in global kidney care. For more science details: www.archbiopartners.com/our-science For investor materials and filings: www.archbiopartners.com/investor-hub The Company has 65,906,366 common shares outstanding. For more information, please contact: Aaron BensonDirector of CommunicationsArch Biopartners, Inc. 647-428-7031Send a message using the Contact Form at: www.archbiopartners.com/contact-us Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca . The scientific and medical content in this release has been approved by the Company’s Chief Science Officer Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

艰难梭菌是一种革兰阳性厌氧芽孢杆菌，主要感染肠道。由艰难梭菌感染引起的肠道感染，轻者表现为腹泻，严重者可发生伪膜性肠炎，且常伴有中毒性巨结肠、肠穿孔、感染性休克等并发症。艰难梭菌感染在老年人群、免疫缺陷人群和外科手术患者中已成为一种常见感染，是住院患者特别是老年患者出现并发症和死亡的重要原因。中国大陆地区进行的一项系统评价结果显示，腹泻患者中，艰难梭菌感染的总患病率为14%。但针对艰难梭菌感染的现有抗生素治疗方案有限。Ibezapolstat是一种新型抗生素，通过特异性抑制革兰阳性菌的PolC型DNA聚合酶IIIα亚基发挥抗菌作用。而由于对肠道稳态有益的菌群如拟杆菌、放线菌等的基因组中缺失polC，因此该药物还可能减少肠道菌群紊乱，肠道菌群紊乱往往是艰难梭菌感染的风险因素。《柳叶刀-微生物》（The Lancet Microbe）发表的一项2b期临床研究表明，新型抗生素ibezapolstat治疗艰难梭菌感染的初始临床治愈率达94%，与当前临床使用的抗生素疗效（100%）相当，且对肠道菌群破坏小，安全性良好，为艰难梭菌感染治疗提供了潜在新选择。截图来源：The Lancet Microbe这是一项随机、双盲、多中心、活性药物对照的2b期研究，纳入年龄18~90岁艰难梭菌感染患者（需满足感染症状且粪便毒素检测阳性），排除近期使用过万古霉素/fidaxomicin/甲硝唑（＞24小时）或其他抗菌药物（48小时内）的患者。研究人员将符合要求的32例患者按1:1随机分组，分别接受口服ibezapolstat（450 mg，每日2次）或活性对照药物（当前临床使用的抗生素之一万古霉素，125 mg，每6小时1次），疗程10天。通过胶囊外观遮蔽实现双盲设计。主要研究终点为治疗结束后48小时维持的初始临床治愈率（定义为治疗结束前24小时内腹泻症状缓解，且在治疗结束后症状缓解至少持续48小时）。疗效分析纳入30例患者（ibezapolstat组16例，活性药物对照组14例），结果显示，ibezapolstat组94%（15/16）患者达到初始临床治愈，与活性药物对照组的100%（14/14）相当，组间差异为-6.3%（95%CI：-30.7%~19.4%，P=1.00），差异无统计学意义。两组腹泻平均缓解时间相似。此外，活性药物对照组2名患者在第12天至第38天之间出现艰难梭菌感染复发。对肠道菌群的检测分析结果显示，ibezapolstat组患者的肠道环境更健康。一方面，ibezapolstat可减少对肠道菌群丰富程度的破坏，肠道菌群如被严重破坏，会增加复发风险。肠道菌群α多样性主要反映个体肠道菌群的种类丰富度、均衡程度。基线时，两组患者肠道菌群α多样性指数基本相当，但治疗后，活性对照组肠道菌群α多样性有所降低。另一方面，ibezapolstat组患者肠道内与维持胆汁酸稳态有关的更多关键菌群得到保留，这些菌群可以将初级胆汁酸代谢为次级胆汁酸，而胆汁酸稳态是预防艰难梭菌感染复发的关键因素。在治疗期间，活性药物对照组的初级胆汁酸增幅远远更高，而ibezapolstat组则未出现这种情况，两组患者的次级胆汁酸水平均在30天时恢复到基线水平。安全性方面，ibezapolstat耐受性良好。两组均未出现药物相关严重不良事件、治疗中断或死亡事件。总之，ibezapolstat治疗艰难梭菌感染的初步疗效与当前临床使用的抗生素疗效相当，且具备调节肠道微生态的潜力。研究结果支持对ibezapolstat进一步开展3期研究，以验证其作用。点击文末“阅读原文/Read more”，即可访问The Lancet Microbe官网阅读完整论文。推荐阅读单次用药，甘油三酯降低近70%！《自然-医学》：新药强效降低多种致动脉硬化的血脂指标强效降压近25 mmHg，73%患者血压达标！NEJM：新药为这类高血压患者带来多重获益减脂26%，保留瘦体重！《柳叶刀》子刊：三重机制新药带来减重新选择打一针管3个流行季？保护效力约63%！《柳叶刀》子刊：新型疫苗有效预防呼吸道感染钟南山院士团队等研究：症状缓解加快1天！抗甲流新药可显著缩短症状发作时间封面图来源：123RF参考资料[1]Taryn A Eubank, Jinhee Jo, Jahangir Alam, et al. Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat versus vancomycin in adults with Clostridioides difficile infection: A phase 2b randomised trial. The Lancet Microbe, https://doi-org.libproxy1.nus.edu.sg/10.1016/j.lanmic.2025.101126免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知