Apnimed宣布在AD109的首个里程碑式III期临床试验中取得积极的初步结果，AD109是一种研究性每日一次口服药丸，用于治疗阻塞性睡眠呼吸暂停-动脉网

Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-daily Oral Pill for Obstructive Sleep Apnea

CISION 等信源发布 2025-05-19 18:00

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AD109 met the primary endpoint, mean change in apnea-hypopnea index (AHI, p=0.001) at 26 weeks, across a broad range of people with mild, moderate and severe obstructive sleep apnea

AD109 在 26 周时达到了主要终点，即在轻度、中度和重度阻塞性睡眠呼吸暂停的广泛人群中，呼吸暂停-低通气指数 (AHI, p=0.001) 的平均变化。

Study participants treated with AD109 achieved a mean reduction in AHI of 55.6% from baseline and achieved significantly improved oxygenation and reduced disease severity

接受AD109治疗的受试者AHI基线平均降低了55.6%，氧合情况显著改善，疾病严重程度减轻。

AD109 is a first-in-class, anti-apneic neuromuscular modulator which targets the root cause of OSA by increasing upper airway muscle tone during sleep

AD109 是一种首创的抗呼吸暂停神经肌肉调节剂，通过在睡眠期间增加上气道肌肉张力来针对 OSA 的根本原因。

Apnimed expects topline results in Q3'25 from its second Phase 3 clinical trial, LunAIRo, and plans to submit an NDA to the U.S. FDA for AD109 by early 2026

Apnimed预计将在2025年第三季度从其第二项III期临床试验LunAIRo中获得主要结果，并计划在2026年初向美国FDA提交AD109的新药申请（NDA）。

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

，

May 19, 2025

2025年5月19日

/PRNewswire/ -- Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed's lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes.

/PRNewswire/ -- Apnimed, Inc.是一家致力于构建行业领先的第一类口服药物候选产品组合的制药公司，专注于解决阻塞性睡眠呼吸暂停（OSA）及其他睡眠相关呼吸疾病的根源。今天，该公司宣布了其关键的第三阶段SynAIRgy临床试验的积极顶线结果。该试验评估了Apnimed的主要候选药物AD109（2.5毫克羟丁宁/75毫克阿托莫西汀）在患有轻度、中度和重度OSA的成人中的疗效和安全性，并覆盖所有体重类别。

The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). The topline results for the primary and multiple secondary endpoints were similar to the results observed in the previous 4-week .

SynAIRgy 试验达到了其主要终点：与安慰剂相比，26 周时睡眠呼吸暂停-低通气指数 (AHI) 较基线的平均变化 (p=0.001)。主要终点和多个次要终点的顶线结果与之前 4 周试验中观察到的结果相似。

MARIPOSA Phase

蝴蝶阶段

clinical trial

临床试验

. AD109 was generally well-tolerated, and the most common adverse events were consistent with earlier AD109 clinical trials. No serious adverse events related to AD109 were reported in the SynAIRgy trial.

AD109 通常具有良好的耐受性，最常见的不良事件与早期的 AD109 临床试验一致。在 SynAIRgy 试验中，没有报告与 AD109 相关的严重不良事件。

An estimated 80 million people in

估计有8000万人在

the United States

美国

and one billion people worldwide are living with OSA. OSA is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. AD109 is designed to target the neurobiology of the hypoglossal motor nucleus by increasing signals to the upper airway muscles during sleep, leading to the reduction or prevention of upper airway collapse. .

全世界有十亿人患有OSA。OSA是由两种重叠的机制引起的：睡眠期间的神经肌肉功能障碍和易感的解剖异常。AD109旨在通过增加睡眠时向气道上部肌肉发出的信号，针对舌下运动核的神经生物学机制，从而减少或防止上气道塌陷。

'Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited treatment options,' said

“今天对Apnimed和数百万长期受有限治疗选择困扰的OSA患者来说是一个里程碑时刻，”

Larry Miller

拉里·米勒

, MD, Chief Executive Officer of Apnimed. 'The positive results from our Phase 3 SynAIRgy trial bring us closer to realizing our vision of offering a simple, safe, and effective oral drug — one that is grounded in science, driven by unmet need, and centered on people with OSA. We believe these results represent the dawn of a new era in the OSA treatment paradigm.

，医学博士，Apnimed首席执行官。“我们三期SynAIRgy试验的积极结果让我们更接近实现提供一种简单、安全且有效的口服药物的愿景——这一药物以科学为基础，由未满足的需求驱动，并以人为中心。我们相信这些结果代表了OSA治疗模式新时代的曙光。”

We are deeply grateful to the patients, investigators, and clinical teams whose partnership and commitment made this achievement possible. Importantly, these results increase our confidence in the expected outcome of the second Phase 3 clinical trial, LunAIRo, with topline results expected in Q3'25.'.

我们深切感谢那些合作和承诺使这一成就成为可能的患者、研究人员和临床团队。重要的是，这些结果增强了我们对第二项三期临床试验LunAIRo预期结果的信心，其顶线结果预计将在2025年第三季度公布。

Additional Efficacy Results

额外的疗效结果

In addition to meeting the primary endpoint, AD109 also demonstrated improvements in other secondary and exploratory endpoints, including:

除了达到主要终点外，AD109 还展示了在其他次要和探索性终点方面的改善，包括：

Meaningful improvements in oxygenation as assessed by hypoxic burden (p<0.0001) and oxygen desaturation index (p=0.001)

通过低氧负荷（p<0.0001）和氧减饱和指数（p=0.001）评估的氧合有显著改善。

51.2% of participants treated with AD109 showed a reduction in OSA disease severity category

51.2%的接受AD109治疗的参与者表现出OSA疾病严重程度类别的降低。

22.3% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour)

22.3%的接受AD109治疗的参与者达到了完全的OSA疾病控制（定义为AHI <5事件/小时）

'These Phase 3 topline results are highly encouraging and represent the potential for a much-needed innovation in the treatment of OSA,' said

“这些第三阶段的初步结果非常令人鼓舞，代表了在OSA治疗方面亟需的创新潜力，”

Patrick Strollo, Jr.

帕特里克·斯特罗洛二世

, MD, study chair of the SynAIRgy clinical trial and Vice Chair of Medicine for Veteran's Affairs at the

医学博士，SynAIRgy临床试验的首席研究员，同时也是退役军人事务部的医学副主席

University of Pittsburgh

匹兹堡大学

School of Medicine. 'For too long, progress in OSA has been limited, leaving many people with OSA without sustainable treatment options. The results from SynAIRgy suggest that if approved, AD109 could offer a compelling new treatment option — a novel oral drug that targets the neuromuscular root cause of airway obstruction in sleep apnea and holds promise for transforming care for a broad range of patients.' .

医学院。“长久以来，OSA 的进展一直有限，导致许多 OSA 患者缺乏可持续的治疗选择。SynAIRgy 的研究结果表明，如果获得批准，AD109 可能提供一个令人信服的新治疗选择 —— 一种针对睡眠呼吸暂停中气道阻塞的神经肌肉根本原因的新型口服药物，并有望为广泛的患者群体转变护理方式。”

'OSA should be considered a top public health priority: it is a serious, common, chronic disease that affects a wide range of people, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity,' said

“OSA 应被视为首要的公共卫生优先事项：它是一种严重的、常见的、慢性疾病，影响广泛的人群，包括所有年龄组、种族和体重级别，无论是否肥胖的男性和女性。”

Monica Mallampalli

莫妮卡·马拉姆帕利

, PhD, President and CEO of the Alliance of Sleep Apnea Partners. 'There is a vast need for new treatment options. We welcome innovations like this, which are long overdue for our patient community. The SynAIRgy results offer people hope that an oral therapy is on the horizon that could make it easier for them to manage their OSA and reclaim their lives.'.

博士，睡眠呼吸暂停伙伴联盟的总裁兼首席执行官。“对于新的治疗方案有着巨大的需求。我们欢迎像这样的创新，这对我们的患者群体来说早已是期待已久。SynAIRgy 的研究结果为人们带来了希望，即一种口服疗法可能即将问世，这将使他们更容易管理自己的阻塞性睡眠呼吸暂停（OSA）并重获新生。”

Advancing AD109

推进AD109

Apnimed plans to submit a New Drug Application (NDA) for AD109 to the U.S. Food and Drug Administration (FDA) by early 2026 for regulatory review. The full data for SynAIRgy will be presented at a medical congress later this year and published in a peer-reviewed scientific journal. Apnimed also anticipates the availability of topline data in Q3 2025 from the second Phase 3 LunAIRo trial, a one-year study of AD109 in adults with OSA..

Apnimed 计划在 2026 年初向美国食品药品监督管理局 (FDA) 提交 AD109 的新药申请 (NDA)，以进行监管审查。SynAIRgy 的完整数据将在今年晚些时候的医学大会上公布，并发表在同行评审的科学期刊上。Apnimed 还预计，第二项 III 期 LunAIRo 试验的初步数据将于 2025 年第三季度发布，这是一项针对患有阻塞性睡眠呼吸暂停 (OSA) 的成人患者使用 AD109 的为期一年的研究。

About the SynAIRgy Study

关于SynAIRgy研究

The SynAIRgy study (

SynAIRgy 研究 (

NCT05813275

) was a randomized, double blind, placebo-controlled, parallel-arm six-month clinical trial of AD109, a fixed dose combination of aroxybutynin 2.5mg/atomoxetine 75mg, in participants with OSA who are intolerant of or currently refuse continuous positive airway pressure (CPAP) therapy. The trial enrolled 646 adult participants from 73 centers in the US and .

）是一项随机、双盲、安慰剂对照、平行组的六个月临床试验，测试AD109（固定剂量组合：2.5毫克氧丁宁/75毫克阿托莫西汀）在无法耐受或目前拒绝持续气道正压通气（CPAP）治疗的OSA患者中的效果。该试验从美国73个中心招募了646名成年参与者。

Canada

加拿大

. Participants were randomized 1:1 to either AD109 or placebo and instructed to take their assigned treatment once-daily before bedtime. SynAIRgy is the largest Phase 3 clinical trial of a medication to treat OSA.

参与者被随机分配为1:1接受AD109或安慰剂，并被指示在睡前每日一次服用指定的治疗药物。SynAIRgy是针对OSA治疗药物的最大规模的第三阶段临床试验。

Enrolled participants in SynAIRgy were representative of the real-world patient population, including the diverse demographic composition of

SynAIRgy 的注册参与者代表了现实世界中的患者群体，包括多样的人口统计特征组成。

the United States

美国

and the typical profiles seen in a sleep clinic population. Participants included 49.1% females, multiple racial groups, and varied weight classes spanning healthy weight, overweight, and with obesity. Participants were distributed across OSA severity levels, including mild (34.4%), moderate (42.4%), and severe (23.2%).

以及在睡眠诊所人群中常见的典型特征。参与者包括49.1%的女性、多个种族群体，以及涵盖健康体重、超重和肥胖的不同体重类别。参与者分布在OSA严重程度的不同级别，包括轻度（34.4%）、中度（42.4%）和重度（23.2%）。

Participants had symptoms reflective of the OSA patient experience. .

参与者表现出反映OSA患者体验的症状。

About AD109

关于AD109

AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI).

AD109旨在成为首个通过直接解决阻塞性睡眠呼吸暂停患者上呼吸道塌陷的神经肌肉根本原因来改善睡眠期间氧合的药物治疗。它是首款同类组合药物，包含新型抗胆碱能药物aroxybutynin和选择性去甲肾上腺素再摄取抑制剂（NRI）阿托莫西汀。

Their combined pharmacological synergy targets the underlying neuromuscular cause of OSA. AD109 is a once-daily pill taken at bedtime that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA..

它们的联合药理协同作用针对OSA的潜在神经肌肉病因。AD109是一种每日一次在睡前服用的药片，旨在降低干预的复杂性，可能帮助更多人从有效、恢复性的睡眠中受益。在以复杂和侵入性治疗选项为特征的疾病中，AD109可能是一个简单的解决方案，有助于改善OSA患者的氧合和健康福祉。

About Obstructive Sleep Apnea

关于阻塞性睡眠呼吸暂停

Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities.

阻塞性睡眠呼吸暂停（OSA）是一种严重的、慢性的与睡眠相关的呼吸疾病，患者在睡眠期间上气道反复塌陷，导致间歇性缺氧。它由两种重叠的机制引起：睡眠期间的神经肌肉功能障碍和易感的解剖异常。

OSA affects individuals across all walks of life, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity. An estimated 80 million people in .

阻塞性睡眠呼吸暂停影响各行各业的人，包括所有年龄组、种族和体重级别的男性和女性，无论是肥胖者还是非肥胖者。估计有8000万人受到影响。

the United States

美国

and one billion people worldwide suffer from OSA. Up to 80% of people living with OSA are undiagnosed and therefore untreated.

全球有十亿人患有OSA。高达80%的OSA患者未被诊断，因此也未接受治疗。

An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, including cardiovascular disease, neurocognitive impairment, metabolic dysfunction, and early mortality.

患有OSA的个体一晚可能会经历数百次睡眠呼吸暂停事件，每次事件都会降低血氧水平，并对维持正常健康和功能至关重要的细胞功能产生负面影响。如果不能有效治疗OSA，会增加严重长期健康后果的风险，包括心血管疾病、神经认知障碍、代谢功能障碍以及早逝。

Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in OSA..

然而，大多数被诊断为OSA的患者拒绝、放弃或未充分利用治疗。目前，尚无可用的药物治疗能够直接解决OSA中存在的潜在神经肌肉功能障碍。

About Apnimed

关于Apnimed

Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. We believe the introduction of simple, once-nightly oral drugs has the potential to dramatically expand diagnosis and the reach of treatment for people with OSA.

Apnimed是一家私人持有的临床阶段制药公司，致力于改变与睡眠相关的呼吸系统疾病的治疗格局。我们相信，引入简单、每晚一次的口服药物有可能大幅扩大OSA患者的诊断和治疗范围。

OSA, like other common chronic diseases such as diabetes or hypertension, would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive..

OSA（阻塞性睡眠呼吸暂停）与其他常见的慢性疾病如糖尿病或高血压一样，如果有多种作用机制不同的药物，将能更全面地应对疾病病理生理的异质性。Apnimed 展望了一个新时代，新颖的口服疗法将简化干预措施，扩大诊断和治疗的覆盖范围，并帮助更多人获得所需的氧气和恢复性睡眠以实现茁壮成长。

Based in

总部位于

Cambridge, Mass.

马萨诸塞州剑桥市

, Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. Our lead candidate, AD109, could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries.

Apnimed公司正在推进一系列口服药物候选产品的研发，旨在改善患有阻塞性睡眠呼吸暂停（OSA）及其他睡眠相关呼吸障碍人群的氧合水平。我们的主要候选药物AD109可能成为OSA全新口服治疗模式的催化剂，而这一领域历史上仅限于使用笨重的设备或进行侵入性手术。

AD109 is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is also developing several therapies as part of its joint venture with Shionogi & Co., Ltd., Shionogi-Apnimed Sleep Science. .

AD109目前正处于治疗轻度、中度和重度OSA的III期临床试验阶段。Apnimed还通过与盐野义制药株式会社的合资企业——盐野义-Apnimed睡眠科学，开发多种疗法。

Learn more at apnimed.com or follow us on

了解更多，请访问 apnimed.com 或关注我们

and

和

领英

。

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媒体联系人：

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