拜耳启动在房颤患者中研究性GIRK4抑制剂的II期临床试验-动脉网

Bayer initiates Phase II study of investigational GIRK4 inhibitor in patients with atrial fibrillation

拜耳等信源发布 2026-09-09 14:38

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可切换为仅中文

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September

九月

2026

08:30 AM

上午 08:30

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer initiates Phase II study of investigational GIRK4 inhibitor in patients with atrial fibrillation

拜耳启动在研GIRK4抑制剂治疗心房颤动患者的II期临床试验

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

GIRK4 (BAY 3670549) is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach to control the electrical activity of cardiomyocytes in patients with atrial fibrillation (AFib) / AFib is the most common type of sustained cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure.

GIRK4（BAY 3670549）是一种在研的高选择性G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，正在被评估作为控制心房颤动（AFib）患者心肌细胞电活动的一种潜在新方法。心房颤动是最常见的持续性心律失常（心律不齐），全球影响超过6,000万人，并且是中风和心力衰竭的重要危险因素。

1,2,3

/ Robust data from the Phase I first-in-human, dose-escalation study supports advancing GIRK4 inhibitor to the next phase of development / Derived from the strategic research alliance with the Broad Institute of MIT and Harvard, BAY 3670549 further strengthens Bayer’s cardiovascular development portfolio.

I期首次人体剂量递增研究提供的有力数据支持将GIRK4抑制剂推进至下一开发阶段 / BAY 3670549源自与麻省理工学院和哈佛大学布罗德研究所的战略研究联盟，进一步丰富了拜耳的心血管产品开发管线。

Berlin, September 9, 2026

柏林，2026年9月9日

– Bayer announced today the initiation of a global Phase II clinical trial (

– 拜耳今日宣布启动一项全球II期临床试验（

NCT07625215

) evaluating BAY 3670549, an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential as a new approach to control the electrical activity of heart cells in patients with atrial fibrillation (AFib). The Phase II single-treatment study in a randomized, double-blind, placebo-controlled, parallel-group, multi-cohort design, will investigate the efficacy, safety and tolerability, as well as pharmacodynamics and pharmacokinetics of BAY 3670549 in adult patients with AFib.

）评估BAY 3670549，这是一种在研的高选择性G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，有望成为控制心房颤动（AFib）患者心肌细胞电活动的新方法。这项II期单药治疗研究采用随机、双盲、安慰剂对照、平行组、多队列设计，将调查BAY 3670549在成年AFib患者中的疗效、安全性和耐受性，以及其药效学和药代动力学特性。

BAY 3670549 demonstrated a favorable safety and tolerability profile in healthy participants in the completed first-in-human single-ascending-dose Phase I study, supporting its continued clinical advancement and strengthening Bayer’s cardiovascular development portfolio..

BAY 3670549在已完成的首次人体单次递增剂量I期临床试验中，在健康受试者中展现出良好的安全性和耐受性特征，这为其后续临床开发提供了支持，并进一步丰富了拜耳的心血管产品研发管线。

“The start of the Phase II marks an important step in our commitment to redefining what may be possible in cardiovascular care, with GIRK4 inhibition carrying the potential to meaningfully advance the treatment of atrial fibrillation, a condition affecting millions of people worldwide,” said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development at Bayer’s Pharmaceuticals Division.

拜耳制药部门研发与早期开发负责人Dominik Ruettinger医学博士、哲学博士表示：“二期临床试验的启动标志着我们在致力于重新定义心血管护理可能性方面迈出了重要一步，GIRK4抑制有望显著推进心房颤动的治疗，这是一种影响全球数百万人的疾病。”

“We are advancing this program because patients and physicians need fast-acting and well-tolerated treatment options that can make a real difference.”.

“我们推进该计划，是因为患者和医生需要起效迅速且耐受性良好的治疗方案，以带来真正的临床获益。”

BAY 3670549, which emerged from Bayer’s strategic research alliance with the Broad Institute, is being investigated as a novel approach for rapid cardioversion to normal sinus rhythm. If successful, it could provide a fast-acting and well-tolerated treatment option that may help reduce the burden on both patients and healthcare systems by offering a potential alternative to electrical cardioversion, the current gold standard for AFib, which often requires anesthesia or sedation, external defibrillation and prolonged hospital-based care..

BAY 3670549 源自拜耳与博德研究所的战略研究联盟，目前正作为快速转复为正常窦性心律的新型疗法接受研究。如果成功，它有望提供一种起效迅速且耐受性良好的治疗选择，为房颤（AFib）患者提供电复律的潜在替代方案。电复律是当前房颤治疗的黄金标准，但通常需要麻醉或镇静、外部除颤以及长期的住院护理。因此，该药物可能有助于减轻患者和医疗系统的负担。

AFib is the most common type of sustained cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure.

房颤是最常见的持续性心律失常（心律不齐），影响全球超过6000万人，并且是中风和心力衰竭的重要危险因素。

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About GIRK4 inhibitor (BAY 3670549)

关于GIRK4抑制剂（BAY 3670549）

BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach

BAY 3670549 是一种在研的高选择性 G 蛋白偶联内向整流钾通道 4（GIRK4）抑制剂，正作为潜在的新疗法进行评估

to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).

帮助控制心房颤动（AFib）患者的心肌细胞电活动。

GIRK4 channels are specialized proteins that regulate the electrical activity of heart cells by facilitating the flow of potassium ions (K+) in response to the neurotransmitter acetylcholine (ACh). This mechanism is particularly crucial during the later phases of the heart’s electrical signaling, specifically during the atrial effective refractory period (AERP).

GIRK4通道是一类 specialized 蛋白质，通过促进钾离子（K+）在神经递质乙酰胆碱（ACh）作用下的流动，来调节心肌细胞的电活动。这一机制在心脏电信号传导的后期阶段尤为关键，特别是在心房有效不应期（AERP）期间。

Increased activity of these channels shortens the AERP in the atria (the upper chambers of the heart), thereby reducing the recovery time after each heartbeat. This alteration in recovery time can contribute to the onset and persistence of AFib..

这些通道活性的增加会缩短心房（心脏的上部腔室）的有效不应期，从而减少每次心跳后的恢复时间。这种恢复时间的改变可能促成心房颤动的发生和持续。

About the study (

关于本研究（

NCT07625215

)

）

A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase II study will investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with AFib.

一项安慰剂对照、平行组、双盲、随机、多队列的II期研究将评估BAY 3670549在成年房颤患者中的疗效、安全性、耐受性、药效学和药代动力学。

The study will compare BAY 3670549 to a placebo in patients with AFib who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm.

本研究将在需要接受电复律治疗的心房颤动（AFib）患者中，比较BAY 3670549与安慰剂的疗效。电复律是一种帮助心脏恢复正常节律的操作。

In the Phase I study, BAY 3670549 was proven to be well-tolerated in healthy male and female participants.

在I期研究中，BAY 3670549被证明在健康男性和女性受试者中耐受性良好。

About Atrial fibrillation

关于心房颤动

AFib is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty efficiently, leading to impaired blood flow and an increased risk of blood clot formation.

心房颤动（AFib）是最常见的持续性心脏节律紊乱（心律失常）之一。它由心脏上部腔室（心房）中快速且无序的电信号引起，导致心房快速而不规则地颤动和收缩。因此，心房无法有效排空，进而导致血流受阻，并增加血栓形成的风险。

These clots can break loose, travel to the brain, and cause a stroke. In addition, AFib disrupts the coordinated function of the upper and lower chambers of the heart, impairing overall cardiac performance and leading to symptoms such as palpitations, shortness of breath, fatigue, and a reduced quality of life in many patients..

这些血栓可能脱落，随血流到达脑部，引发卒中。此外，心房颤动会扰乱心脏上下腔室的协调功能，损害整体心脏性能，导致许多患者出现心悸、气短、疲劳等症状，并降低其生活质量。

The prevalence of AFib continues to increase globally. Projection studies show that the number of people with AFib will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe.

房颤的全球患病率持续上升。预测研究显示，到2050年，美国房颤患者人数将增至1,590万；到2060年，欧洲房颤患者人数将增至1,790万。

People with AFib are 5 times more likely to suffer a stroke than people without AFib.

房颤患者发生卒中的风险是无房颤者的5倍。

AFib-related strokes are also associated with a 50% likelihood of death within one year.

房颤相关卒中患者在一年内的死亡风险也高达50%。

The current gold standard to treat acute AFib episodes is electric cardioversion (ECV). This is an effective but resource-intensive and logistically challenging procedure, which is normally scheduled in advance and typically requires sedation or even anesthesia to safely deliver an electrical shock to the patient and restore the heart to its normal sinus rhythm..

目前治疗急性房颤发作的金标准是电复律（ECV）。这是一种有效但资源密集且后勤挑战较大的程序，通常需要提前安排，并且通常需要镇静甚至麻醉，以安全地向患者施加电击并使心脏恢复正常的窦性心律。

10,11

On the other hand, currently available anti-arrhythmic drugs (AADs), which are commonly used for the management of symptomatic AFib, can’t be applied to broad patient populations due to a number of contraindications (such as for patients with structural heart disease) and safety risks, including abnormal heart rhythms and sudden death.

另一方面，目前可用的抗心律失常药物（AADs）常用于症状性心房颤动的管理，但由于存在多种禁忌证（例如结构性心脏病患者）以及包括心律失常和猝死在内的安全风险，无法广泛应用于广大患者群体。

Additionally, they show limited, short-term efficacy, require close monitoring and bear the risk of serious side effects..

此外，它们的疗效有限且短暂，需要密切监测，并存在严重副作用的风险。

12,13

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域拥有核心能力的全球性企业。秉承“人人享有健康，无人遭受饥饿”的使命，公司的产品和服务旨在通过支持应对全球人口增长和老龄化所带来的重大挑战，帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提升盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠和品质。在2025财年，集团员工人数约为88,000人，销售额达456亿欧元。

R&D expenses amounted to 5.8 billion euros. For more information, go to .

研发费用为58亿欧元。更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

在 Facebook 上关注我们：

http://www.facebook.com/bayer

Forward-Looking Statements

前瞻性陈述

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本新闻稿可能包含基于拜耳管理层当前假设和预测的前瞻性陈述。各种已知和未知的风险、不确定性和其他因素可能导致公司未来的实际业绩、财务状况、发展或表现与本文给出的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳在其公开报告中讨论的因素，这些报告可在拜耳网站（网址：）上获取。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

. 本公司不承担任何更新这些前瞻性陈述或使其与未来事件或发展保持一致的责任。

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

拜耳股份公司是一家在全球拥有运营子公司的控股公司。文中提及“拜耳”或“本公司”时，根据上下文需要，可能指代一家或多家子公司。

Atrial fibrillation: epidemiology, screening and digital health

心房颤动：流行病学、筛查与数字健康

，

Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

Linz, Dominik 等，《柳叶刀区域健康 - 欧洲》，第 37 卷，100786

American Heart Association,

美国心脏协会，

Why Atrial Fibrillation Matters | American Heart Association

为何心房颤动至关重要 | 美国心脏协会

Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities,

科尔内伊·J，本杰明·E.J，马尼亚尼·J.W，心房颤动：全球负担与全球机遇，

Heart

心脏

2021;107:516-518.

2021年；第107卷：516-518页。

Atrial fibrillation: epidemiology, screening and digital health

心房颤动：流行病学、筛查与数字健康

，

Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

林茨，多米尼克等，《柳叶刀区域健康 - 欧洲》，第37卷，100786

American Heart Association,

美国心脏协会，

Why Atrial Fibrillation Matters | American Heart Association

为何心房颤动至关重要 | 美国心脏协会

Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities,

Kornej J，Benjamin EJ，Magnani JW，心房颤动：全球负担与全球机遇，

Heart

心脏

2021;107:516-518.

Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

心房颤动：流行病学、筛查与数字健康，Linz, Dominik 等，《柳叶刀区域健康·欧洲》，第37卷，100786

Singleton MJ, Imtiaz‐Ahmad M, Kamel H, O'Neal WT, Judd SE, Howard VJ, Howard G, Soliman EZ, Bhave PD. Association of atrial fibrillation without cardiovascular comorbidities and stroke risk: from the REGARDS study. Journal of the American Heart Association. 2020 Jun 16;9(12):e016380.

Singleton MJ, Imtiaz‐Ahmad M, Kamel H, O'Neal WT, Judd SE, Howard VJ, Howard G, Soliman EZ, Bhave PD. 无心血管合并症的心房颤动与卒中风险的关联：来自REGARDS研究的结果。《美国心脏协会杂志》。2020年6月16日；9(12):e016380。

Alberts M, Chen YW, Lin JH, Kogan E, Twyman K, Milentijevic D. Risks of Stroke and Mortality in Atrial Fibrillation Patients Treated With Rivaroxaban and Warfarin. Stroke. 2020 Feb;51(2):549-555. doi: 10.1161/STROKEAHA.119.025554. Epub 2019 Dec 31. PMID: 31888412; PMCID: PMC7004448.

Alberts M, Chen YW, Lin JH, Kogan E, Twyman K, Milentijevic D. 接受利伐沙班和华法林治疗的心房颤动患者的卒中和死亡风险。《卒中》。2020年2月；51(2):549-555。doi: 10.1161/STROKEAHA.119.025554。电子版发布于2019年12月31日。PMID: 31888412；PMCID: PMC7004448。

Nusair M, Flaker GC, Chockalingam A. Electric cardioversion of atrial fibrillation. Mo Med. 2010 Jan-Feb;107(1):59-64. PMID: 20222298; PMCID: PMC6192814.

Nusair M, Flaker GC, Chockalingam A. 心房颤动的电复律. Mo Med. 2010年1月-2月;107(1):59-64. PMID: 20222298; PMCID: PMC6192814.

十一

Why Atrial Fibrillation Matters | American Heart Association

为何心房颤动至关重要 | 美国心脏协会

十二

Andrade JG. Ablation or drug therapy for initial atrial fibrillation. Ann Cardiothorac Surg 2024;13(1):71-76. doi: 10.21037/acs-2023-afm-0159

Andrade JG. 初始心房颤动的消融治疗或药物治疗。《心胸外科年鉴》2024;13(1):71-76。doi: 10.21037/acs-2023-afm-0159

Journal Article, Zimetbaum, Peter, Antiarrhythmic Drug Therapy for Atrial Fibrillation 2012, Circulation 381-389, 125, N 2 doi:10.1161/CIRCULATIONAHA.111.019927,

期刊文章，Zimetbaum, Peter，《心房颤动的抗心律失常药物治疗》，2012年，《循环》杂志，第381-389页，第125卷，第2期，doi:10.1161/CIRCULATIONAHA.111.019927

https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.111.019927

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Anna Kanmaz

安娜·坎马兹

PH Innovation Communications Comms BP Bioethics & Late-Stage Development

PH创新传播、传播业务伙伴、生物伦理学及后期开发

anna.kanmaz@bayer.com

+49 1741463541

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