Baloxavir Marboxil

BOTHELL, Wash., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc.’s (Nasdaq: COCP) management announces its participation in the upcoming Virtual Investor Summit Microcap Forum in August and the H.C. Wainwright 26th Annual Global Investment Conference in September. “We look forward to showcasing key near-term clinical milestones at two upcoming investment conferences,” said James Martin, CFO and co-CEO of Cocrystal. “We expect to report topline results in 2024 from our influenza A Phase 2a challenge study with our novel oral PB2 inhibitor CC-42344 with the final report expected to be filed in 2025. We also expect to report topline results from the Phase 1 multiple-ascending cohorts in late 2024 or early 2025 with our novel oral protease inhibitor CDI-988 for the treatment of norovirus and coronavirus infections.” Virtual Investor Summit Microcap Forum The presentation and Q&A session will begin Tuesday, August 20, 2024 at 9:00 a.m. Eastern timeInvestors can register here to view the live presentation and to ask questions H.C. Wainwright 26th Annual Global Investment Conference An on-demand presentation will be available to conference participants on the H.C. Wainwright platform beginning Monday, September 9, 2024 at 7:00 a.m. Eastern timeManagement will be available for in-person and virtual one-on-one meeting throughout the conference; institutional investors and industry professionals can register to attend the conference virtually or in-person at the Lotte New York PalaceThe presentation will be available on the Company’s website CC-42344 – Pandemic and Seasonal Influenza A PB2 Inhibitor CC-42344 is our novel, broad-spectrum antiviral candidate to treat pandemic and seasonal influenza A. CC-42344 inhibits influenza A’s viral replication by binding to a highly conserved PB2 site. We discovered CC-42344 using our proprietary structure-based drug discovery platform. We are conducting a Phase 2a influenza challenge study in the United Kingdom to evaluate safety and efficacy in healthy volunteers. CC-42344 demonstrated favorable safety and tolerability, and pharmacokinetics profiles in a Phase 1 study. In vitro testing indicated CC-42344’s potent antiviral activity against influenza A strains as well as against pandemic and seasonal strains and strains resistant to Tamiflu® and Xofluza®. CDI-988 – Pan-viral Protease Inhibitor Against Noroviruses and CoronavirusesWe have developed a novel protease inhibitor, CDI-988, to treat norovirus and coronavirus infection, including SARS-CoV-2 and its variants. CDI-988 was specifically designed and developed as an oral broad-spectrum antiviral inhibitor using our structure-based drug discovery platform to bind to a highly conserved region of noroviruses, coronaviruses and other 3CL viral proteases. CDI-988 is being evaluated in a randomized, double-blind, placebo-controlled Phase 1 trial for safety, tolerability and pharmacokinetics. About Cocrystal Pharma, Inc.Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential characteristics and efficacy of product candidates and the expected timing and results of the clinical trials for such product candidates. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with and complete clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. and foreign governments, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact:LHA Investor RelationsJody Cain310-691-7100jcain@lhai.com Media Contact:JQA PartnersJules Abraham917-885-7378Jabraham@jqapartners.com # # #

关注并星标CPHI制药在线 8月12日，健康元1类新药「TG-1000胶囊」的上市申请获CDE受理。TG-1000是一款创新抗流感新药，是一种新型帽依赖性核酸内切酶抑制剂，被开发用于12周岁及以上单纯性甲型和乙型流感急性感染无并发症患者。 TG-1000最早由太景医药研发（北京）有限公司以及太景生物科技股份有限公司研发。2023年3月，健康元获得TG-1000在中华人民共和国，含中国香港及中国澳门特别行政区，但不包括中国台湾地区的开发、制造和商业化授权。 TG-1000是一种前体药物，通过酯酶水解作用可转化成活性成份TG-0527，抑制流感病毒聚合酶酸性蛋白核酸内切酶，从而抑制病毒RNA合成。早期研究数据显示：TG-1000具有起效快、抑制病毒时间长、耐受性好、口服不受食物影响的特点，能同时有效抑制甲型、乙型流感病毒。 2023年9月，TG-1000针对12周岁及以上单纯性甲型和乙型流感急性感染无并发症患者的3期临床试验启动。初步统计分析结果显示：TG-1000组与安慰剂组的所有流感症状缓解的中位时间分别为60.9小时和87.9小时，达到主要疗效指标并具有统计学差异（P<0.0001）。安全性方面，试验中未发生死亡或与药物相关的严重不良反应，TG-1000组的不良事件（AE）发生率与安慰剂组相近。 此外，TG-1000临床使用比较方便，单次口服即可有效阻断病毒复制及传播，且不受48小时内服药黄金期的限制。期待TG-1000早日获批上市，造福流感患者。  国内多款RNA聚合酶抑制剂报产 流感是由流感病毒引起的传染性呼吸系统疾病，是目前世界上最严重的公共卫生挑战之一。据统计，全球每年流感季节性流行在全球可导致300万-500万例重症病例，29万-65万例呼吸道疾病相关死亡病例。 抗流感病毒药物是治疗和控制流感的重要手段之一，目前获批上市的抗流感病毒药物主要包括神经氨酸酶抑制剂（如奥司他韦、扎那米韦、帕拉米韦)、血凝素抑制剂（如阿比多尔）和RNA聚合酶抑制剂（如玛巴洛沙韦、法维拉韦）三类。 据米内网数据，2021至2023年我国这三类RNA聚合酶抑制剂累计销售额超173亿元，连续三年增长率均超120%。具体品种来看，奥司他韦市场占比占比最大，超80%，2023年奥司他韦中国总销售额近88亿元。 不过未来抗流感病毒药物市场格局有望发生变化，以玛巴洛沙韦为代表的RNA聚合酶抑制剂或成为抗流感病毒药物的主力军。玛巴洛沙韦（商品名：速福达/Xofluza)是近20年来全球首款获批的全新机制抗流感药物，通过抑制流感病毒的cap-依赖型核酸内切酶来抑制病毒复制，已被批准用于流感的治疗和预防，适应症人群已扩大至5岁及以上儿童和成人。用于治疗时，应在流感症状出现不超过48小时内服药。而且，玛巴洛沙韦获批剂型除了片剂，还有混悬剂。 玛巴洛沙韦最早于2018年在日本获批，2021年在国内获批，其上市后销售额增速明显，据悉其2022年、2023年在国内的销售额分别为0.6亿元和超5亿元。 法维拉韦也属于RNA聚合酶抑制剂，但与玛巴洛沙韦不同，它是一种核苷类抗病毒药物，口服吸收后可在细胞内被磷酸化，转换为具有生物活性的法维拉韦核苷三磷酸（favipiravir-RTP），通过与病毒RNA聚合酶相互作用来抑制病毒基因组复制和转录，发挥抗病毒作用。该药被批准用于治疗成人新型或再次流行的流感（仅限于其它抗流感病药物治疗无效或效果不佳时使用）。不过，法维拉韦半衰期较短，需每日给药两次。 除了玛巴洛沙韦和法维拉韦，目前仅国内就有多款在研RNA聚合酶抑制剂，如昂拉地韦（ZSP1273，众生药业）、GP681(青峰药业/银杏树药业)、玛赛洛沙韦ZX-7101A，(征祥医药)、玛氘诺沙韦片（ADC189，先声药业/安帝康生物）、WXSH0208（辰欣药业）。由于流感病毒RNA聚合酶是由酸性蛋白（PA）、碱性蛋白1（PB1）和碱性蛋白2（PB2）三个亚基组成的异源三聚体复合物，其中PB1亚基主要参与病毒基因组的复制过程，PB2亚基主要负责与宿主pre-mRNA帽状结构结合，协助完成内切酶的剪切过程。在研RNA聚合酶抑制剂的作用位点存在差异。 其中昂拉地韦是一款聚合酶碱性蛋白2（PB2）抑制剂，临床前研究显示其对多种甲型流感病毒的抑制能力显著优于奥司他韦以及玛巴洛沙韦，且对于奥司他韦耐药的病毒株、玛巴洛沙韦耐药的病毒株和高致病性禽流感病毒株均具有很强的抑制作用。 已公布的昂拉地韦片治疗成人单纯性甲型流感的3期临床试验结果显示：主要终点指标中位七项流感症状（咳嗽、咽痛、头痛、鼻塞、发热或寒颤、肌肉或关节痛和疲劳）的缓解时间较安慰剂组显著缩短>24小时（39%），其中H1亚型感染患者较安慰剂组显著缩短>32小时。此外，昂拉地韦组患者的中位发热缓解时间较安慰剂组显著缩短39%。而且，在病毒学指标、安全性评价和耐药性风险方面，昂拉地韦也表现出显著的优势。2023年12月，昂拉地韦治疗成人单纯性甲型流感的上市申请获CDE受理。 GP681是一款聚合酶酸性蛋白（PA）抑制剂，它是一种前药，通过水解转化为活性代谢产物GP1707D07，选择性抑制流感病毒PA的帽依赖性核酸内切酶，从而抑制流感病毒的复制。临床前研究显示：GP681能广谱、高效地抑制病毒复制，对甲型流感病毒、乙型流感病毒、禽流感病毒均有效。GP681使用方便，服用一次的剂量就可在一天内治愈流感，且能持续起效1周以上。2023年12月，GP681在国内申报上市，适应症可能为：青少年及成人无并发症的急性流感。 玛赛洛沙韦是新一代聚合酶酸性蛋白（PA）核酸内切酶抑制剂，具有广谱抗流感病毒的特性，对甲、乙型流感病毒、高致死禽流感病毒等均具有良好的抗病毒活性。其治疗成人无并发症的单纯性流感的3期临床试验已达到主要终点：玛赛洛沙韦给药组“所有流感症状缓解时间”较对照组显著缩短，具有统计学差异。而且，玛赛洛沙韦给药组流感病毒（RNA）转阴时间、发热缓解时间等次要终点指标也较对照组有显著缩短，且具有统计学差异。2024年2月，玛赛洛沙韦在国内申请上市。 玛氘诺沙韦是一款聚合酶酸性蛋白（PA）抑制剂，对甲型和乙型流感病毒均有效，包括对奥司他韦耐药的流感株和禽流感株（H7N9，H5N1）。玛氘诺沙韦由安帝康生物自主研发，2023年10月先声药业获得其在中国的独家商业化权益。 临床试验结果显示：玛氘诺沙韦抗流感药效比肩玛巴洛沙韦，优于奥司他韦，且具有口服药效不受食物影响的优势，具有显著的疗效和较高的安全性。而且，玛氘诺沙韦使用方便，全病程仅需口服一粒，就可在24小时内阻止流感病毒复制。 玛氘诺沙韦治疗成人、青少年甲型、乙型流感的3期临床结果已达到临床主要终点，玛氘诺沙韦组所有流感症状缓解时间、病毒RNA及病毒滴度转阴时间均较安慰剂组有显著缩短（P<0.0001）。 目前，安帝康生物就玛氘诺沙韦片治疗流感的上市申请与中国国家药品监督管理局CDE进行沟通，以推进玛氘诺沙韦片的上市进程。此外，玛氘诺沙韦针对2~11周岁流感儿童患者的3期临床试验也已启动。 WXSH0208是辰欣药业研发的口服小分子流感病毒RNA聚合酶PA亚基抑制剂，拟用于甲型和乙型流感的治疗。在体内药效学中，针对流感病毒小鼠感染模型进行体内药效及动物耐受性的探索和验证，发现WXSH0208在耐受性良好的剂量下，对乙流病毒的药效要优于或相当于上市的相关抑制剂药物，对甲流病毒的药效则相当。目前，该药治疗成人无并发症的单纯性流感的2期临床试验正在进行中。 总结 整体来看，目前全球已批准多款抗流感病毒药物。但由于流感的季节性流行和爆发，畅销抗流感病毒药物奥司他韦还是经常出现断货。新型、高效抗流感病毒药物玛巴洛沙韦的获批上市为流感的预防和治疗带来新的选择，而且以其为代表的RNA聚合酶抑制剂成为抗流感病毒药物研发的新方向。目前，仅国内就有多款RNA聚合酶抑制剂申请上市，期待这些药物早日获批上市，成为抗击流感的中坚力量。 END END END END 【智药研习社直播预告】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~