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Committee Recommends Expanding Sample Size After Interim Analysis Places Study in Protocol-Defined Promising Zone SAN DIEGO, June 1, 2026 /PRNewswire/ -- Ansun Biopharma, Inc., a clinical-stage biopharmaceutical company, today announced that its independent Data Monitoring Committee (DMC) has issued a positive recommendation following a prespecified interim efficacy and safety review of the Company's Phase 3 clinical trial (DAS181-3-01). DAS181 is being evaluated for the treatment of parainfluenza pneumonia infection in immunocompromised patients requiring oxygen support. The DMC convened to conduct its second scheduled review, evaluating interim safety and primary endpoint efficacy data at approximately the prespecified 75% information fraction for the originally planned 72-subject Cohort 1 sample size. The review was conducted pursuant to prespecified procedures in the study protocol and statistical analysis plan. The study remains blinded. Following its review, the DMC recommended that the study continue and that the sample size be updated based on prespecified recalculation to support adequate statistical power for the final analysis. The Committee noted that the observed interim results indicate the study is in the "promising zone" as defined in the protocol. "Parainfluenza pneumonia can be severe and life-threatening in immunocompromised patients who require oxygen support, and there remains no FDA-approved antiviral therapy specifically indicated for this setting," said site investigator Dr. Rosy Priya Kodiyanplakkal, Assistant Professor of Clinical Medicine at Weill Cornell Medicine and an infectious disease specialist at New York-Presbyterian/Weill Cornell Medical Center. "The current Phase 3 study evaluating DAS181 is highly important for this vulnerable population, where new treatment options are urgently needed." About the DAS181-3-01 Trial DAS181-3-01 is a Phase 3 randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of DAS181 for the treatment of parainfluenza pneumonia in immunocompromised subjects requiring oxygen support. About DAS181 DAS181 (Fludase®) is an investigational inhaled recombinant sialidase fusion protein designed to remove sialic acid receptors from the surface of airway epithelial cells, thereby preventing influenza and parainfluenza viruses from attaching to and infecting respiratory cells. DAS181 has received Fast-Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of parainfluenza pneumonia infection in immunocompromised patients requiring oxygen support. About Ansun Biopharma, Inc. Ansun Biopharma, Inc., is a clinical-stage biopharmaceutical company focused on developing innovative antiviral therapies to address unmet medical needs in patients especially vulnerable to serious respiratory infections. The Company is completing a Phase 3 clinical trial of its lead product candidate, DAS181, a host-directed antiviral. By targeting the host cell rather than the pathogen, DAS181 offers a differentiated broad-spectrum antiviral modality. For more information, please visit or using the identifier NCT03808922. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential clinical benefit of DAS181, the conduct and completion of the DAS181-3-01 trial, implementation of the sample-size update, timing of enrollment and final results, regulatory interactions, and the potential for DAS181 to address an unmet medical need. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those implied by such statements, including that interim DMC recommendations may not predict final study results; the study may not meet its primary or secondary endpoints; additional enrollment may be delayed or may not be completed; safety findings may emerge; regulators may not agree with the study analysis, or interpretation of results; and DAS181 may not receive regulatory approval. Ansun Biopharma undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. SOURCE Ansun Biopharma, Inc. 21% more press release views with Request a Demo

摘要：流感病毒每年引发季节性流行，偶尔还会导致全球大流行，严重威胁公众健康 。为了应对流感，人们一直在研发抗病毒策略。本文回顾了目前已获批的流感治疗药物、处于临床评估阶段的新化合物和单克隆抗体，以及临床前研究中有潜力的分子。同时，探讨了联合疗法和靶向蛋白降解等创新治疗方法。由于现有药物存在局限性，研发具有高耐药屏障和广谱抗病毒活性的新型抗流感药物迫在眉睫 。一、引言流感病毒分为甲型和乙型，可引发急性呼吸道综合征，全球每年因流感导致大量病例、重症和死亡 。流感病毒的高突变率和基因组重配特性，使其不断产生新的变异株，逃避人体免疫系统，这给疫苗和药物研发带来了极大挑战 。目前的流感疫苗存在免疫印记、效果有限和需每年重新配方等问题 。因此，研发抗流感药物成为重要的防控手段，本文将对相关治疗策略进行详细介绍。二、流感的临床治疗药物目前，抗流感临床治疗药物主要作用于病毒复制周期的不同阶段（结合图1 Replication cycle of influenza virus and crucial steps targeted by virus-directed antiviral compounds理解）。M2 离子通道抑制剂：20 世纪 80 年代获批的金刚烷胺和金刚乙胺，通过抑制病毒离子通道 M2，阻止病毒脱壳，但因耐药性和严重副作用，现已不再临床使用 。神经氨酸酶抑制剂（NAIs）：这类药物能阻止病毒神经氨酸酶（NA）切割细胞表面的唾液酸，从而抑制病毒释放 。常见的 NAIs 包括扎那米韦、奥司他韦、帕拉米韦和拉尼米韦等，它们对甲型和乙型流感病毒均有效，但部分病毒已出现对 NAIs 的耐药性 （具体药物信息可查看表1 Currently approved drugs for clinical management of influenza）。RNA 聚合酶抑制剂：包括法匹拉韦和巴洛沙韦等。法匹拉韦是一种核苷类似物，可诱导病毒 RNA 产生致命突变，但有严重副作用 。巴洛沙韦是一种帽依赖性内切核酸酶抑制剂，能抑制病毒转录起始，但也可能诱导耐药性 。其他药物：恩替沙明碘化物和阿比多尔也被用于流感治疗。恩替沙明碘化物通过抑制病毒 RNA 合成发挥作用，阿比多尔则通过阻止病毒血凝素（HA）诱导的膜融合来抑制病毒感染。三、处于临床研发阶段的抗流感药物针对病毒的药物：许多单克隆抗体正处于临床评估阶段，如针对 HA 的单克隆抗体，它们通过结合 HA 的不同部位来阻止病毒进入细胞，但部分在临床试验中效果不佳 。此外，还有针对病毒其他蛋白（如 M2、NP、PB2 等）的抑制剂也在研究中 （详细信息可参考表2 Virus-directed anti-influenza agents under clinical and preclinical development）。针对宿主的药物：部分药物通过作用于宿主细胞因子来间接抑制病毒复制，如 DAS181 可去除病毒结合的唾液酸受体；阿托伐他汀、地尔硫䓬和丙磺舒等药物也被尝试用于流感治疗 。此外，一些免疫调节剂如达尼瑞辛和塞来昔布，可调节宿主免疫反应，减轻炎症 （可结合图3 Immunomodulatory and anti-inflammatory agents for the treatment of influenza virus infection理解宿主导向药物的作用机制）。四、联合治疗方法联合抗病毒疗法在治疗多种病毒感染方面已显示出有效性，对于流感治疗，联合疗法可降低单一药物剂量，减少副作用和耐药性的产生 。例如，奥司他韦与其他药物的联合使用在一些研究中取得了较好效果，但并非所有联合方案都比单一疗法更有效，仍需更多大规模临床试验来验证 。五、临床前研究中有前景的抗流感药物抑制病毒进入和释放的策略：针对 HA 的研究包括开发靶向 HA 不同部位的单克隆抗体、小分子抑制剂、肽类和碳水化合物结合剂等 。同时，针对宿主细胞中参与病毒进入的因子（如钙离子通道、蛋白激酶 C 等）的抑制剂也在研究中 。此外，对 NA 的研究包括开发新型 NAIs 和靶向 NA 的单克隆抗体 。抑制病毒转录和复制的策略：以核蛋白（NP）为靶点的抑制剂可分为抑制 NP 与病毒 RNA 相互作用、NP 寡聚化和 NP 核输出的化合物 。针对 RNA 聚合酶（RdRp）亚基的研究，除了已有的抑制剂类似物，还包括开发新型的帽依赖性内切核酸酶抑制剂（CENI）、PB2 帽结合域抑制剂、PB1 抑制剂以及针对 RdRp 亚基相互作用的抑制剂等 。此外，针对宿主细胞中参与病毒转录、复制和 vRNP 转运的因子的抑制剂也在探索中 。调节宿主细胞抗病毒免疫反应的策略：通过调节宿主的先天免疫反应来对抗流感病毒，如开发 RIG-I 小分子激动剂和模拟天然配体的化合物，激活宿主的抗病毒状态 。同时，针对流感病毒非结构蛋白 1（NS1）的抑制剂也在研究中，以恢复宿主的先天免疫反应 。六、靶向蛋白降解：抗流感药物设计的新前沿靶向蛋白降解（TPD）技术是一种新兴的制药技术，主要基于蛋白酶靶向嵌合体（PROTACs） 。PROTACs 是一种双功能分子，能特异性结合目标蛋白并招募细胞内的 E3 泛素连接酶，使目标蛋白通过泛素 - 蛋白酶体途径降解 。目前，针对流感病毒的 HA、NA 和 PA 蛋白的 PROTACs 已被开发，部分在体外和体内实验中显示出良好的抗病毒活性 。此外，类似的疏水标签（HyT）技术也在探索中，有望为抗流感药物设计提供新的方向 。七、总结流感病毒感染虽然通常表现为轻度季节性呼吸道疾病，但具有引发大流行的风险，因此需要不断加强预防和治疗手段的研究 。目前的抗流感药物存在耐药性等问题，直接作用于病毒的药物相对更有优势，但仍需优化 。PB1 核苷抑制剂和蛋白 - 蛋白相互作用抑制剂在耐药性方面表现较好，但还需要进一步改进以降低毒性和提高疗效 。PROTAC 技术为抗流感药物研发带来了新希望，未来需要开发更多具有广谱抗流感活性、不同作用机制的化合物和单克隆抗体，以应对流感病毒的威胁 。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。