CYTOKINETICS与箕星宣布扩大合作范围,携手将OMECAMTIV MECARBIL引进中国市场;RTW将加码注资CYTOKINETICS
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Members of Cytokinetics’ senior management team will host a conference call and webcast today, December 20, at 8:30 AM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 8997061.
An archived replay of the webcast will be available via Cytokinetics’ website until January 3, 2022. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 8997061 from December 20, 2021 at 11:30 AM Eastern Time until January 3, 2022.
Omecamtiv mecarbil是一种选择性小分子心肌肌球蛋白激活剂,这款靶向肌节的正性肌力药物作为同类首创的在研新药1,可直接靶向心脏收缩机制,与靶点结合后能够增加心脏收缩期间与肌动蛋白相互作用的心肌肌球蛋白头部区域的数量。Omecamtiv mecarbil旨在增加每个心动周期中的活性肌动蛋白-肌球蛋白横桥数量,从而在射血分数降低的心力衰竭(HFrEF)患者中增强受损的心肌收缩力。临床前研究显示,omecamtiv mecarbil可增强心肌收缩力,且不增加心肌细胞内的钙浓度或心肌耗氧量2-4。
目前正在omecamtiv mecarbil的开发项目中评估其能否用于治疗HFrEF,其中包括GALACTIC-HF和METEORIC-HF两项III期临床试验,后者旨在评价omecamtiv mecarbil治疗与安慰剂相比对运动能力的影响。
心力衰竭是一种严重疾病,全球患病人数超过6400万5(中国患者人数远高于1000万6),其中约有半数患者的左心室功能降低7,8。心力衰竭是65岁及以上人群住院和反复入院的首要原因9, 10。尽管标准治疗已日渐普及,且医疗护理方面也有所进展,但心力衰竭患者的预后仍不容乐观11。据估计,40岁以上人群中有20%存在心衰发作风险;在诊断为心力衰竭的患者中,约有50%在初次住院后5年内死亡12,13。美国预计有超过200万人的射血分数<30%,表明其可能存在重度心力衰竭14。
Cytokinetics是一家处于后期阶段的生物制药公司,致力于同类首创肌肉激活剂和新一代肌肉抑制剂的发现、开发和商业化,为肌肉性能受损的进行性衰弱疾病患者提供潜在治疗选择。Cytokinetics作为肌肉生物学和肌肉运动力学领域的领军者,目前正在开发小分子候选药物,此类药物专门设计用于影响肌肉的功能和收缩力。鉴于Cytokinetics的新型心肌激活剂omecamtiv mecarbil在一项治疗心力衰竭患者的大型国际III期临床试验GALACTIC-HF中获得了积极结果,公司据此将美国NDA申报工作提上日程。Cytokinetics正在进行METEORIC-HF研究,这是omecamtiv mecarbil的第二项III期临床试验。Cytokinetics还在同步开发新一代心肌肌球蛋白抑制剂aficamten,拟用于治疗肥厚型心肌病(HCM)。公司日前宣布,在aficamten治疗梗阻性HCM患者的II期临床试验REDWOOD-HCM中,队列1和队列2收获了积极结果。Cytokinetics计划在梗阻性HCM患者中开展aficamten的III期临床试验SEQUOIA-HCM,目前正在筹备研究启动工作。Cytokinetics还拥有另一款在研药物reldesemtiv,这是一种快速骨骼肌肌钙蛋白激活剂,目前正在肌萎缩侧索硬化(ALS)患者中进行III期临床试验COURAGE-ALS。Cytokinetics延续其在肌肉生物学及相关药理学领域20多年来的开拓创新历史,始终专注于肌肉功能障碍和肌无力疾病。
如需了解关于Cytokinetics的更多信息,请访问www.cytokinetics.com。
CYTOKINETICS®和C形徽标是CYTOKINETICS在美国及其他部分国家的注册商标。
箕星是一家总部位于中国上海的生物制药公司,致力于将创新科学和药物带给罹患严重危及生命疾病的中国患者。箕星由RTW Investments, LP于2019年投资创立,与全球多家生物技术公司开展合作,通过独特、创新治疗药物的开发和商业化,应对心血管和眼科等疾病领域尚未满足的医疗需求。凭借强劲且不断壮大的产品管线、经验丰富的管理团队和以患者为中心的理念,箕星将为大中华地区的患者群体带来持久而深远的影响。
RTW Investments, LP(RTW)是一家总部位于纽约的全球性全生命周期投资公司,专注于发掘生物制药和医疗技术领域具有变革和突破意义的创新成果。作为行业内和学术界的主要合作伙伴,RTW将深厚的科学专业知识与“以解决方案为导向的投资方法”相结合,为新兴疗法和开发新兴疗法的公司和/或学者提供支持。如需了解关于RTW的更多信息,请访问www.RTWfunds.com。
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to: statements relating to the likelihood or timeliness of regulatory approval by FDA or any regulatory authorities in Greater China or elsewhere for omecamtiv mecarbil; Cytokinetics’ research and development activities; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with JIXING. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ latest Quarterly Report on Form 10-Q.
联系人:
Cytokinetics
Joanna Siegall
参考文献:
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