Ibezapolstat

This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx This prior work included high-resolution elucidation of the interaction of ibezapolstat with its molecular target, DNA polymerase IIIC (pol IIIC, also known as PolC), with mechanistic findings that explain its properties of lacking cross-resistance with other antibiotics and not fostering the emergence of vancomycin-resistant Enterococcus strains, a unique differentiation among anti-CDI antibiotics The new research partnership aims to generate the first-ever 3D structure of PolC from methicillin-resistant Staphylococcus aureus (MRSA) in complex with DNA and an Acurx inhibitor to advance discovery of new antibiotics to treat infections caused by this high-priority pathogen This partnership will extend mechanistic research into PolC inhibition to accelerate the development of novel agents for the systemic treatment of infections caused by a range of Gram-positive pathogens resistant to currently available antibiotics STATEN ISLAND, N.Y., Aug. 10, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced a new scientific partnership with Leiden University Medical Center (LUMC) in the Netherlands. Prior work under the November 2025 research grant from Health-Holland to Leiden University Medical Center and Acurx for DNA pol IIIC Inhibitors included detailed three-dimensional structures for three poI IIIC complexes from Enterococcus and was published in Nature Communications in 2025 [A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens]* []. These results have yielded valuable insights into the structure-function relationship for the PolC class of inhibitors. This new partnership aims to generate the first-ever 3D structure of PolC from MRSA in complex with DNA and an Acurx inhibitor to advance discovery of new antibiotics to treat this high-priority clinical pathogen. This new partnership will extend mechanistic research into PolC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics. Wiep Klaas Smits, PhD, Associate Professor, LUMC Department of Medical Microbiology will be the lead researcher in collaboration with Meindert Lamers, PhD, Associate Professor, LUMC Department of Cell and Chemical Biology and Mia Urem, PhD, from Leiden University Medical Center in the Netherlands. Dr. Smits stated: "Whereas the previous work established a conserved mode of action for this novel class of antibiotics, the new project will allow us to investigate more subtle differences between PolC's from different Gram-positive organisms and will improve our understanding of how these different novel antibiotics interact with their target beyond their inhibitory group." Robert J. DeLuccia, Executive Chairman of Acurx, stated: "This work is very important, when coupled with the recently reported initial data from laboratory experiments in MRSA-infected neutropenic mice at the University of Houston School of Pharmacy demonstrating that Acurx DNA pol IIIC antibiotics showed favorable gut-sparing effects to be a class effect while maintaining systemic antibacterial activity . It will pave the way for further rational design of novel DNA pol IIIC inhibitors based on new structure-activity relationships." He further stated: "Treating systemic infections, like those caused by MRSA, without promoting antibiotic-induced gut dysbiosis has the potential for a transformational shift in the treatment paradigm for antibacterial therapy." The scientific poster presented at ESCMID Global in April 2026 is available on our website: Acurx's portfolio of preclinical compounds includes clinical applications for infections caused by MRSA such as: ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint and diabetic foot infections. Additionally, Acurx intends to leverage its preclinical development program for S.aureus infections for the treatment of post-exposure inhalational anthrax caused by B. anthracis, a Bioterrorism Category A Threat-Level pathogen. Acurx's DNA PolC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by CDC. About the Prior Research Project, Leiden University Medical Center, the Research Consortium and the New Scientific Partnership between LUMC and Acurx Antimicrobial resistant microorganisms are a major threat to global health and pose a significant economic burden. Increasing resistance to multiple agents and resistance to so called last-resort antibiotics underscore the necessity to develop therapeutics that have a novel mode of action. DNA replication is a process that can be successfully targeted by small molecules. Ibezapolstat, an inhibitor of the replicative DNA polymerase pol IIIC from Gram- positive bacteria identified by screening library of dGTP analogues, has shown promising results for the treatment of Clostridioides difficile Infection in a recently completed Phase 2 clinical trial and is ready to enter Phase 3 clinical trials. Prior work under the November 2025 research grant from Health-Holland to Leiden University Medical Center and Acurx for DNA pol IIIC Inhibitors included detailed three-dimensional structures for three poI IIIC complexes from Enterococcus and was published in Nature Communications [A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens] []. These results have yielded valuable insights into the structure-function relationship for the PolC (pol IIIC) class of inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx. The partnership aims to generate the first-ever 3D structure of Pol C from methicillin-resistant Staphylococcus aureus (MRSA) in complex with DNA and an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen. This new partnership will extend mechanistic research into pol IIIC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics. Leiden University was the first university to be established in the Netherlands. Its motto is praesidium libertatis – bastion of freedom. The University wishes to create an increasingly attractive and challenging working climate for top academics and young researchers that is guided by quality and excellence. Leiden University Medical Center (LUMC) research aims to meet the highest international standards of quality and academic integrity. LUMC promotes excellent research through greater collaboration, both disciplinary and interdisciplinary; stronger positioning and greater scope for top talent; and better supervision and more support for young researchers. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. Acurx has received FDA guidance in meeting minutes from a July 13, 2026 Type C Meeting to discuss ibezapolstat's (IBZ) Phase 3 clinical program, including the potential to submit an NDA (New Drug Application) based on a single Phase 3 trial and a clinical trial design intended to support indications for both treatment and reduction of recurrence of Clostridioides difficile infection (CDI). FDA stated that it is open to further discussion on the totality of evidence from the clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial and any other clinical trials conducted prior to the pre-NDA meeting, particularly if the clinical efficacy results are robust. Additionally, the Agency agreed that a successful clinical outcome from a single IBZ-ASPIRE Phase 3 trial, supported by the open-label IBZ-PATHFINDER Phase 2 trial in multiply-recurrent CDI (rCDI) will allow NDA filing for both the acute treatment and the reduction of recurrence of CDI. Trial start-up activities for the IBZ-PATHFINDER ground-breaking clinical trial in patients with rCDI have been initiated with patient enrollment to begin in the next few months. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit . About MRSA While ibezapolstat for the treatment of C. difficile Infection (CDI) is ready to advance to Phase 3 international pivotal trials, Acurx's R&D platform has sustainability for additional new product candidates from its pipeline of systemic (oral and IV) antibiotics to treat infections caused by other susceptible and antimicrobial resistant bacteria, including infections caused by MRSA. The CDC estimates ~323,700 hospital cases of MRSA infections annually with ~10,600 deaths. In a recent CDC surveillance study in hospitalized patients in the US, MRSA accounted for 52% of all infections, almost twice as many as MDR Gram-negative infections. Clinical applications for these infections include: ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint, diabetic foot infections. Acurx's DNA pol IIIC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by CDC. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission on March 12 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & CEO Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. 21% more press release views with Request a Demo

This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx 这一新的合作伙伴关系建立在之前报告的、由荷兰健康机构（Health-Holland）于2025年11月向莱顿大学和Acurx授予的创新研究资助所取得的成果基础之上。This prior work included high-resolution elucidation of the interaction of ibezapolstat with its molecular target, DNA polymerase IIIC (pol IIIC, also known as PolC), with mechanistic findings that explain its properties of lacking cross-resistance with other antibiotics and not fostering the emergence of vancomycin-resistant . 这项先前的研究包括高分辨率阐明伊贝佐波司特与其分子靶点DNA聚合酶IIIC（pol IIIC，也称为PolC）的相互作用，其机制性发现解释了该药物缺乏与其他抗生素的交叉耐药性且不促进万古霉素耐药性出现的特性。Enterococcus 肠球菌strains, a unique differentiation among anti-CDI antibiotics 菌株，抗艰难梭菌感染抗生素中的独特区分The new research partnership aims to generate the first-ever 3D structure of PolC from methicillin-resistant 这项新的研究合作旨在首次生成耐甲氧西林菌株PolC的三维结构Staphylococcus 葡萄球菌aureus 金黄色(MRSA)incomplexwithDNA and anAcurxinhibitor to advance discovery of new antibiotics to treat infections caused by this high-priority pathogen （耐甲氧西林金黄色葡萄球菌，MRSA）与DNA及Acurx抑制剂形成的复合物，以推进新型抗生素的发现，用于治疗由这种高优先级病原体引起的感染This partnership will extend mechanistic research into PolC inhibition to acceleratethedevelopmentofnovelagentsfor thesystemic treatment of infections caused bya range of Gram-positive pathogens resistant to currently available antibiotics 该合作伙伴关系将把对PolC抑制的机制研究延伸至加速开发新型药物，以系统性治疗由多种对现有抗生素耐药的革兰氏阳性病原体引起的感染。STATEN ISLAND, N.Y. 纽约州斯塔滕岛, ，Aug. 10, 2026 2026年8月10日/PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq: /PRNewswire/ -- Acurx Pharmaceuticals, Inc.（纳斯达克：ACXP ACXP) ('Acurx' or the 'Company'), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced a new scientific partnership with Leiden University Medical Center (LUMC) in the Netherlands. Acurx（以下简称“Acurx”或“公司”）是一家处于临床阶段的生物制药公司，致力于开发用于治疗难治性细菌感染的新型抗生素。该公司今日宣布与荷兰莱顿大学医学中心（LUMC）建立新的科学合作伙伴关系。Prior work under the November 2025 research grant from Health-Holland to Leiden University Medical Center and Acurx for DNA pol IIIC Inhibitors included detailed three-dimensional structures for three poI IIIC complexes from Enterococcus and was published in Nature Communications in 2025 [A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens]* [. 在2025年11月Health-Holland向莱顿大学医学中心和Acurx提供的关于DNA聚合酶IIIC抑制剂的研究资助下，先前的工作包括来自肠球菌的三个Pol IIIC复合物的详细三维结构，并于2025年发表在《自然通讯》上[一种独特的抑制剂构象选择性靶向革兰氏阳性优先病原体的DNA聚合酶PolC]*。https://rdcu.be/fxMVQ https://rdcu.be/fxMVQ]. These results have yielded valuable insights into the structure-function relationship for the PolC class of inhibitors. This new partnership aims to generate the first-ever 3D structure of PolC from MRSAincomplexwithDNA and anAcurxinhibitor to advance discovery of new antibiotics to treat this high-priority clinical pathogen. ]。这些结果为PolC类抑制剂的结构-功能关系提供了宝贵的见解。这项新的合作旨在首次解析耐甲氧西林金黄色葡萄球菌（MRSA）的PolC与DNA及Acurx抑制剂复合物的三维结构，从而推动新型抗生素的发现，以应对这种高优先级的临床病原体。This new partnership will extend mechanistic research into PolC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics.. 这项新的合作伙伴关系将拓展针对PolC抑制的机制研究，以加速开发对多种耐现有抗生素的革兰氏阳性病原体具有全身活性的新型药物。WiepKlaasSmits,PhD,AssociateProfessor,LUMCDepartmentofMedicalMicrobiologywillbetheleadresearcherincollaborationwithMeindertLamers,PhD,AssociateProfessor,LUMCDepartmentofCell and Chemical Biology and Mia Urem, PhD, from Leiden University Medical Center in the Netherlands. Wiep Klaas Smits 博士（莱顿大学医学中心微生物学系副教授）将担任首席研究员，并与莱顿大学医学中心细胞与化学生物学系副教授 Meindert Lamers 博士以及荷兰莱顿大学医学中心的 Mia Urem 博士合作开展研究。Dr.Smits stated: 'Whereas the previous work established a conserved mode of action for this novel class of antibiotics, the new project will allow us to investigate more subtle differences between PolC's from different Gram-positive organisms and will improve our understanding of how these different novel antibiotics interact with their target beyond their inhibitory group.'. 斯米茨博士表示：“尽管先前的研究确立了这类新型抗生素的保守作用模式，但新项目将使我们能够探究不同革兰氏阳性生物体中PolC之间更细微的差异，并增进我们对这些不同新型抗生素如何在其抑制基团之外与靶点相互作用的理解。”Robert J. DeLuccia, Executive Chairman of Acurx, stated: 'This work is very important, when coupled with the recently reported initial data from laboratory experiments in MRSA-infected neutropenic mice at the University of Houston School of Pharmacy demonstrating that Acurx DNA pol IIIC antibiotics showed favorable gut-sparing effects to be a class effect while maintaining systemic antibacterial activity . Acurx 执行董事长 Robert J. DeLuccia 表示：“这项工作非常重要，尤其是结合休斯顿大学药学院最近在耐甲氧西林金黄色葡萄球菌（MRSA）感染的中性粒细胞减少小鼠模型中开展的实验室实验所报告的初步数据。该数据显示，Acurx 的 DNA 聚合酶 IIIC 抗生素在保持全身抗菌活性的同时，展现出良好的肠道保护作用，且这一特性属于该类药物的类效应。”It will pave the way for further rational design of novel DNA pol IIIC inhibitors based on new structure-activity relationships.' He further stated: 'Treating systemic infections, like those caused by MRSA, without promoting antibiotic-induced gut dysbiosis has the potential for a transformational shift in the treatment paradigm for antibacterial therapy.'. “这将为基于新的构效关系进一步合理设计新型DNA聚合酶IIIC抑制剂铺平道路。”他进一步表示：“在不引发抗生素诱导的肠道菌群失调的情况下治疗全身性感染（如由耐甲氧西林金黄色葡萄球菌引起的感染），有望使抗菌治疗范式发生变革性转变。”The scientific poster presented at ESCMID Global in April 2026 is available on our website: 在2026年4月于ESCMID全球会议上展示的科学海报可在我们的网站上获取：www.acurxpharma.com www.acurxpharma.comAcurx's portfolio of preclinical compounds includes clinical applications for infections caused by MRSA such as: ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint and diabetic foot infections. Additionally, Acurx intends to leverage its preclinical development program for . Acurx的临床前化合物组合包括针对由耐甲氧西林金黄色葡萄球菌（MRSA）引起的感染的临床应用，例如：急性细菌性皮肤及皮肤结构感染（ABSSI）、医院获得性及呼吸机相关性细菌性肺炎、伴或不伴脓毒症和/或心内膜炎的菌血症、骨和关节感染以及糖尿病足感染。此外，Acurx打算利用其临床前开发计划来推进。S.aureus 金黄色葡萄球菌infections for the treatment of post-exposureinhalational anthrax caused by 用于治疗由吸入性炭疽引起的暴露后感染的B. B.anthracis 炭疽,aBioterrorismCategoryA Threat-Level pathogen.Acurx's DNA PolC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by CDC. ，一种被归类为生物恐怖主义A类威胁级别的病原体。Acurx公司的DNA PolC抑制剂临床前候选产品已获得美国食品药品监督管理局（FDA）合格传染病产品（QIDP）认定并符合快速通道资格，其靶向的是被美国疾病控制与预防中心（CDC）列为严重威胁优先事项的革兰氏阳性菌感染。About the Prior Research Project, Leiden University Medical Center, the Research Consortium and the New Scientific Partnership between LUMC and Acurx 关于先前研究项目、莱顿大学医学中心、研究联盟以及莱顿大学医学中心与Acurx之间的新科学合作伙伴关系Antimicrobial resistant microorganisms are a major threat to global health and pose a significant economic burden. Increasing resistance to multiple agents and resistance to so called last-resort antibiotics underscore the necessity to develop therapeutics that have a novel mode of action. DNA replication is a process that can be successfully targeted by small molecules. 抗微生物药物耐药性微生物是全球健康的主要威胁，并造成巨大的经济负担。对多种药物的耐药性日益增加，以及对所谓“最后防线”抗生素的耐药性，凸显了开发具有新型作用机制的治疗药物的必要性。DNA复制是一个可以被小分子成功靶向的过程。Ibezapolstat, an inhibitor of the replicative DNA polymerase polIIIC from Gram- positive bacteria identified by screening library of dGTP analogues, has shown promising results for the treatment of . Ibezapolstat 是一种通过筛选 dGTP 类似物文库发现的革兰氏阳性菌复制性 DNA 聚合酶 pol IIIC 抑制剂，在治疗方面已显示出令人鼓舞的结果。Clostridioides difficile 艰难梭菌Infection in a recently completed Phase 2 clinical trial and is ready to enter Phase 3 clinical trials. Prior work under the November 2025 research grant from Health-Holland to Leiden University Medical Center and Acurx for DNA pol IIIC Inhibitors included detailed three-dimensionalstructures for three poI IIIC complexes from Enterococcus and was published in Nature Communications [A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens][. 在一项近期完成的2期临床试验中，该药物已准备好进入3期临床试验。此前，在2025年11月由Health-Holland向莱顿大学医学中心和Acurx提供的关于DNA聚合酶IIIC抑制剂的研究资助下，相关研究详细解析了来自肠球菌的三个Pol IIIC复合物的三维结构，并发表在《自然-通讯》上（《一种独特的抑制剂构象选择性靶向革兰氏阳性优先病原体的DNA聚合酶PolC》）。https://rdcu.be/fxMVQ https://rdcu.be/fxMVQ]. These results have yielded valuable insights into the structure-function relationship for the PolC (pol IIIC) class of inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx. ]。这些结果为PolC（pol IIIC）类抑制剂的结构-功能关系提供了宝贵的见解。这一新的合作关系建立在先前报告的成果基础之上，即莱顿大学与Acurx于2025年11月从Health-Holland获得的创新研究资助所取得的成功结果。The partnership aims to generate the first-ever 3D structure of Pol C from methicillin-resistant . 该合作旨在生成耐甲氧西林金黄色葡萄球菌Pol C的首个三维结构。Staphylococcus aureus 金黄色葡萄球菌(MRSA) in complex with DNA and an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen. This new partnership will extend mechanistic research into pol IIIC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics.. （MRSA）与DNA及Acurx抑制剂形成的复合物，以推动发现治疗这一高优先级临床病原体的新化合物。这项新的合作伙伴关系将把针对Pol IIIC抑制的机制研究进一步拓展，以加速开发对多种耐现有抗生素的革兰氏阳性病原体具有全身活性的新型药物。Leiden University was the first university to be established in the Netherlands. Its motto is praesidium libertatis – bastion of freedom. The University wishes to create an increasingly attractive and challenging working climate for top academics and young researchers that is guided by quality and excellence. 莱顿大学是荷兰建立的第一所大学。其校训为“praesidium libertatis”——自由的堡垒。莱顿大学致力于以质量和卓越为导向，为顶尖学者和青年研究人员营造一个日益具有吸引力和挑战性的工作环境。Leiden University Medical Center (LUMC) research aims to meet the highest international standards of quality and academic integrity. LUMC promotes excellent research through greater collaboration, both disciplinary and interdisciplinary; stronger positioning and greater scope for top talent; and better supervision and more support for young researchers.. 莱顿大学医学中心（LUMC）的研究旨在符合最高的国际质量和学术诚信标准。LUMC 通过加强学科内和跨学科合作、提升顶尖人才的定位并拓展其发展空间，以及改善对青年研究人员的指导与支持，来推动卓越研究。About 关于Acurx Pharmaceuticals, Inc. Acurx 制药公司Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Acurx Pharmaceuticals 是一家处于后期阶段的生物制药公司，专注于开发一类新型小分子抗生素，用于治疗难以治愈的细菌感染。该公司的方法是开发具有革兰氏阳性菌选择性谱（GPSS®）的抗生素候选药物，这类药物能够阻断革兰氏阳性菌特异性酶 DNA 聚合酶 IIIC（pol IIIC）的活性位点，从而抑制 DNA 复制，导致革兰氏阳性细菌死亡。Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).. 其研发管线包括针对革兰氏阳性菌的抗生素候选产品，这些细菌包括艰难梭菌、耐甲氧西林金黄色葡萄球菌（MRSA）、耐万古霉素肠球菌（VRE）、耐药性肺炎链球菌（DRSP）以及炭疽杆菌（炭疽；一种生物恐怖主义A类威胁级别病原体）。Acurx's lead product candidate, ibezapolstat, for the treatment of Acurx 的主要候选产品 ibezapolstat，用于治疗C. difficile 艰难梭菌Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. Acurx has received FDA guidance in meeting minutes from a July 13, 2026 Type C Meeting to discuss ibezapolstat's (IBZ) Phase 3 clinical program, including the potential to submit an NDA (New Drug Application) based on a single Phase 3 trial and a clinical trial design intended to support indications for both treatment and reduction of recurrence of . 艰难梭菌感染（CDI）项目已具备进入国际III期临床试验的条件，但需获得适当的融资。Acurx公司在2026年7月13日举行的C类会议会议纪要中收到了美国食品药品监督管理局（FDA）的指导意见，讨论了ibezapolstat（IBZ）的III期临床计划，包括基于单项III期试验提交新药申请（NDA）的可能性，以及旨在支持治疗适应症和降低复发率适应症的临床试验设计。Clostridioides difficile 艰难梭菌infection (CDI). FDA stated that it is open to further discussion on the totality of evidence from the clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial and any other clinical trials conducted prior to the pre-NDA meeting, particularly if the clinical efficacy results are robust. 感染（CDI）。FDA表示，在完成一项III期临床试验以及在pre-NDA会议之前进行的任何其他临床试验后，其愿意在pre-NDA会议上就临床开发项目的全部证据进行进一步讨论，尤其是在临床疗效结果稳健的情况下。Additionally, the Agency agreed that a successful clinical outcome from a single IBZ-ASPIRE Phase 3 trial, supported by the open-label IBZ-PATHFINDER Phase 2 trial in multiply-recurrent CDI (rCDI) will allow NDA filing for both the acute treatment and the reduction of recurrence of CDI.. 此外，监管机构同意，若单一IBZ-ASPIRE III期临床试验取得成功的临床结果，并由在复发性艰难梭菌感染（rCDI）患者中开展的开放标签IBZ-PATHFINDER II期临床试验提供支持，则将允许提交新药申请（NDA），用于急性治疗以及降低艰难梭菌感染的复发率。Trial start-up activities for theIBZ-PATHFINDER ground-breaking clinical trial in patients with rCDI have been initiated with patient enrollment to begin in the next few months. 针对复发性艰难梭菌感染（rCDI）患者的IBZ-PATHFINDER突破性临床试验的启动工作已展开，患者入组将于未来几个月内开始。The Company's preclinical pipeline includes development of an oral product candidate for treatment ofABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. 该公司的临床前研发管线包括一款用于治疗急性细菌性皮肤及皮肤结构感染（ABSSSI）的口服候选产品的开发，并计划同步开展针对吸入性炭疽的治疗开发项目。To learn more about Acurx Pharmaceuticals and its product pipeline, please visit 欲了解更多关于Acurx Pharmaceuticals及其产品管线的信息，请访问www.acurxpharma.com www.acurxpharma.com. 。About MRSA 关于耐甲氧西林金黄色葡萄球菌（MRSA）While ibezapolstat for the treatment of 而伊贝扎波尔stat用于治疗C. difficile 艰难梭菌Infection (CDI) is ready to advance to Phase 3 international pivotal trials, Acurx's R&D platform has sustainability for additional new product candidates from its pipeline of systemic (oral and IV) antibiotics to treat infections caused by other susceptible and antimicrobial resistant bacteria, including infections caused by MRSA. 艰难梭菌感染（CDI）项目已准备好推进至第三期国际关键性试验。Acurx的研发平台具备可持续性，能够从其全身性（口服和静脉注射）抗生素管线中开发出更多新的候选产品，用于治疗由其他易感菌及耐药菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）引起的感染。The CDC estimates ~323,700 hospital cases of MRSA infections annually with ~10,600 deaths. In a recent CDC surveillance study in hospitalized patients in the US, MRSA accounted for 52% of all infections, almost twice as many as MDR Gram-negative infections.. 美国疾病控制与预防中心（CDC）估计，每年约有323,700例耐甲氧西林金黄色葡萄球菌（MRSA）感染住院病例，导致约10,600人死亡。在美国近期一项针对住院患者的CDC监测研究中，MRSA占所有感染的52%，几乎是多重耐药革兰氏阴性菌感染数量的两倍。Clinical applications for these infections include: ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint, diabetic foot infections. Acurx's DNA pol IIIC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by CDC.. 这些感染的临床应用包括：急性细菌性皮肤及皮肤结构感染（ABSSI）、医院获得性肺炎和呼吸机相关性细菌性肺炎、伴或不伴败血症和/或心内膜炎的菌血症、骨和关节感染以及糖尿病足感染。Acurx公司的DNA聚合酶IIIC抑制剂临床前候选产品符合美国食品药品监督管理局（FDA）的合格传染病产品（QIDP）资格和快速通道资格，其靶点为被美国疾病控制与预防中心（CDC）列为严重威胁优先事项的革兰氏阳性菌感染。Forward-Looking 前瞻性Statements 声明Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words 'believes,' 'anticipates,' 'plans,' 'expects,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 本新闻稿中有关我们未来预期、计划和前景的任何陈述，包括关于我们战略、未来运营、前景、计划和目标的陈述，以及包含“相信”、“预计”、“计划”、“预期”等词语及类似表述的其他陈述，均构成1995年《私人证券诉讼改革法案》意义上的前瞻性陈述。Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission on March 12 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. 由于各种重要因素，实际结果可能与上述前瞻性陈述所指示的结果存在重大差异，这些因素包括：ibezapolstat 是否能从合格传染病产品（QIDP）认定中受益；ibezapolstat 是否能及时推进临床试验进程；ibezapolstat 的临床试验结果是否足以支持提交上市申请，以及若提交申请，ibezapolstat 是否能获得美国食品药品监督管理局（FDA）或寻求批准的其他国家同等监管机构的批准；若 ibezapolstat 获得批准，其是否能成功分销和市场化；以及公司于2026年3月12日向美国证券交易委员会提交的截至2025年12月31日年度的10-K表年报中，以及公司随后向美国证券交易委员会提交的文件中所描述的其他风险和不确定性。Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.. 此类前瞻性陈述仅反映本新闻稿发布之日的情况，除法律另有要求外，Acurx 不承担任何更新这些前瞻性陈述以反映该等陈述日期之后发生的事件或情况的意图或义务。Investor 投资者Contact: 联系方式：Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals 公司DavidP.Luci, President & CEO 大卫·P·卢西，总裁兼首席执行官Tel: 917-533-1469 电话：917-533-1469Email: 电子邮件：[emailprotected] [email protected]SOURCE Acurx Pharmaceuticals, Inc. 来源：Acurx Pharmaceuticals, Inc.21 二十一% 百分比more press release views with 更多新闻稿浏览量Request a Demo 申请演示