BERLIN--(BUSINESS WIRE)--Bayer, a global leader in women’s healthcare, announced today the expansion of the clinical development program for the investigational compound elinzanetant. The first study participants were recently enrolled into NIRVANA, an exploratory Phase II study to evaluate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM)..

柏林--（商业新闻短讯）--拜耳是全球女性医疗保健领域的领导者，今天宣布扩大研究化合物elinzanetant的临床开发计划。第一批研究参与者最近被纳入NIRVANA，这是一项探索性的II期研究，旨在评估依林扎尼坦对更年期睡眠障碍（SDM）女性的疗效和安全性。。

Together with vasomotor symptoms (also known as VMS or hot flashes) and mood symptoms, sleep disturbances belong to the most frequent and disruptive symptoms associated with menopause.1 Approximately 40% to 60% of women experience sleep disturbances during the menopausal transition, which may include trouble falling asleep or staying asleep potentially causing a negative impact on women’s quality of life and limit their daily activities, including performance at work.

连同血管舒缩症状（也称为VMS或潮热）和情绪症状，睡眠障碍属于与更年期相关的最常见和破坏性症状。1大约40%至60%的女性在更年期过渡期间经历睡眠障碍，这可能包括入睡困难或保持睡眠可能会对女性的生活质量产生负面影响，并限制她们的日常活动，包括工作表现。

2,3 SDM may also be associated with negative effects on metabolism, body fat gain, poor cardiovascular health in later life, cognitive health decline, and depressive symptoms.4,5 Current treatments do not specifically target sleep disturbances associated with menopause..

2,3 SDM也可能与代谢的负面影响，体脂增加，晚年心血管健康不佳，认知健康下降和抑郁症状有关。4,5目前的治疗方法并没有专门针对与更年期相关的睡眠障碍。。

“By adding NIRVANA to our broad clinical development program, we are further exploring the potential of elinzanetant to address sleep disturbances associated with menopause, an area of important unmet need in women’s health,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development..

拜耳制药部执行委员会成员、全球研发负责人克里斯蒂安·隆美尔博士表示：“通过将涅盘添加到我们广泛的临床开发计划中，我们正在进一步探索依林扎尼坦解决与更年期相关的睡眠障碍的潜力，更年期是女性健康中一个重要的未满足需求领域。”。。

“Sleep is an incredibly complex aspect of health and the human experience, and unfortunately, its importance is often underestimated and undervalued – for those experiencing menopause this is especially the case,” said Hadine Joffe, M.D., M.Sc, Professor of Psychiatry in the Field of Women’s Health based at Brigham and Women’s Hospital in Boston, an experienced psychiatrist and sleep researcher in women’s mental health...

波士顿布里格姆妇女医院女性健康领域精神病学教授Hadine Joffe医学博士、理学硕士说：“睡眠是健康和人类体验的一个极其复杂的方面，不幸的是，它的重要性经常被低估和低估——对于那些经历更年期的人来说尤其如此。”，一位经验丰富的精神病医生和女性心理健康睡眠研究者。。。

The NIRVANA Phase II trial is a multi-center, double-blind, randomized, parallel-group, placebo-controlled interventional study. It is intended to randomize approximately 78 participants in eight countries to investigate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM).

NIRVANA II期试验是一项多中心，双盲，随机，平行组，安慰剂对照的介入研究。它旨在随机分配八个国家的大约78名参与者，以调查elinzanetant对更年期睡眠障碍（SDM）女性的疗效和安全性。

The primary endpoint for the NIRVANA study is the efficacy of elinzanetant on Wakefulness After Sleep Onset (WASO) at week 4 as measured by polysomnography..

NIRVANA研究的主要终点是通过多导睡眠图测量的elizanetant对第4周睡眠发作后觉醒（WASO）的疗效。。

Additionally, Bayer announced positive topline results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant for the treatment of moderate to severe VMS associated with menopause versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo.

此外，拜耳宣布了关键的III期研究OASIS 1和2的正面结果，该研究评估了研究化合物elinzanetant治疗更年期与安慰剂相关的中度至重度VMS的疗效和安全性。Elinzanetant在两项研究中均成功达到了所有四个主要终点，表明与安慰剂相比，从基线到第4周和第12周，中度至重度血管舒缩症状（VMS，也称为潮热）的频率和严重程度在统计学上显着降低。

Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data2,6 on elinzanetant..

这两项研究还实现了所有三个关键的次要终点，显示从基线到第1周VM的频率在统计学上显着降低，并且与安慰剂相比，睡眠障碍和更年期相关生活质量在统计学上显着改善。在OASIS 1和2研究中观察到的安全性概况与之前发表的关于Elizanetant的数据2,6总体一致。。

About the NIRVANA Study

关于涅盘研究

NIRVANA is an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances.

NIRVANA是一项探索性的II期随机，平行组治疗，双盲研究。主要目的是通过多导睡眠图（PSG）测定，探讨依林扎尼坦对更年期（SDM）相关睡眠障碍的疗效。PSG是研究睡眠和睡眠障碍潜在原因的有效方法。

Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and evaluating the safety of elinzanetant for the treatment of SDM. More information can be found at https://clinicaltrials.gov/study/NCT06112756..

其他目标包括根据患者报告的结果探索依林扎尼坦对SDM的疗效，并评估依林扎尼坦治疗SDM的安全性。有关更多信息，请访问https://clinicaltrials.gov/study/NCT06112756..

The Phase II study NIRVANA is based on improvements in sleep disturbances observed in the Phase IIb study SWITCH-1, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in women with moderate to severe vasomotor symptoms associated with menopause. It also indicated improvements in sleep disturbances as assessed by the global Pittsburgh Sleep Quality Index (PSQI) and the total Insomnia Severity Index (ISI) scores with elinzanetant 120 mg once daily compared to placebo.

II期研究NIRVANA基于IIb期研究SWITCH-1中观察到的睡眠障碍的改善，该研究调查了与安慰剂相比，四种不同剂量的依林扎尼坦对更年期中度至重度血管舒缩症状女性的疗效和安全性。它还表明，与安慰剂相比，全球匹兹堡睡眠质量指数（PSQI）和总失眠严重程度指数（ISI）评分评估的睡眠障碍有所改善。

Full results have been published in March 2023 in Menopause - The Journal of the Menopause Society.2.

全部结果已于2023年3月发表在更年期-更年期学会杂志上。

About the OASIS Clinical Development Program

关于OASIS临床开发计划

The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer..

绿洲elinzanetant的III期临床开发计划目前包括四项III期研究：绿洲1、2、3和4。OASIS 1、2和3研究调查了120 mg elizanetant对绝经相关中度至重度VMS女性的疗效和安全性。OASIS 4研究是临床III期计划的扩展，研究了依林扎尼坦对内分泌治疗或预防乳腺癌引起的中度至重度VMS女性的疗效和安全性。。

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS..

III期临床开发计划的设计和剂量基于两项II期研究（RELENT-1和SWITCH-1）的阳性数据。RELENT-1是一项Ib/IIa期研究，研究了依林扎尼坦的安全性，药代动力学和初步疗效。SWITCH-1是一项IIb期研究，研究了四种不同剂量的依林扎尼坦与安慰剂相比对VMS女性的疗效和安全性。。

About Elinzanetant

关于Elinzanetant

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

Elinzanetant是第一种双重神经激肽-1,3（NK-1,3）受体拮抗剂，在晚期临床开发中用于非激素治疗与更年期相关的中度至重度VMS，每天口服一次。Elinzanetant可以通过调节大脑下丘脑区域（KNDy神经元）中的一组雌激素敏感神经元来解决中度至重度VMS，这些神经元随着雌激素的减少而变得肥大并导致体温调节途径的过度激活，从而破坏导致VMS的体温控制机制。

Elinzanetant may also decrease sleep disturbances associated with menopause..

Elinzanetant还可以减少与更年期相关的睡眠障碍。。

About Menopause

关于更年期

By 2030, the world population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million new women entering this phase each year.7 Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function, and which usually occurs in women during their 40s or early 50s.

到2030年，世界更年期女性人口预计将增加到12亿，每年有4700万新女性进入这一阶段。7更年期是女性生活的过渡阶段，与卵巢功能的逐渐下降有关，通常发生在40多岁或50多岁的女性身上。

It can also be the result of surgical or medical treatment, for example breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.

它也可能是手术或药物治疗的结果，例如乳腺癌治疗。荷尔蒙下降会导致各种症状，这些症状会严重影响女性的健康、生活质量、医疗保健利用率和工作效率。更年期过渡期间最常报告和破坏性症状是VMS，睡眠障碍和情绪变化。

Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective..

解决这些症状是维持更年期功能能力和生活质量的关键，这从医疗保健和社会经济角度来看都是高度相关的。。

About Women’s Healthcare at Bayer

关于拜耳的女性保健

Women’s Health is in Bayer’s DNA and as a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases.

女性健康是拜耳的DNA，作为女性医疗保健领域的全球领导者，拜耳长期致力于通过推进创新治疗组合，为更好的生活提供科学。拜耳公司提供了一系列有效的短效和长效节育方法，以及更年期管理和妇科疾病的治疗方法。

Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in the area of menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives.

拜耳还专注于创新选择，以解决全球女性未满足的医疗需求，并扩大更年期等治疗选择。此外，拜耳计划到2030年，通过资助多方利益相关者援助计划和确保提供负担得起的现代避孕药，每年为中低收入国家的1亿妇女提供计划生育服务。

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations..

这是2020年以后全面可持续性措施和承诺的一部分，符合联合国的可持续发展目标。。

About Bayer

拜耳简介

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。它的产品和服务旨在通过支持应对全球人口不断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。拜耳致力于推动可持续发展，并对其业务产生积极影响。

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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.

与此同时，该集团旨在通过创新和增长来提高其盈利能力和创造价值。拜耳品牌代表着全世界的信任、可靠性和质量。2022财年，该集团雇佣了约101000名员工，销售额为507亿欧元。不含特殊项目的研发费用为62亿欧元。

For more information, go to www.bayer.com..

欲了解更多信息，请访问www.bayer.com。。

Find more information at https://pharma.bayer.com/

更多信息，请访问https://pharma.bayer.com/

Follow us on LinkedIn: Bayer | Pharmaceuticals

在LinkedIn上关注我们：拜耳制药

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千瓦（2024-0010e）

Forward-Looking Statements

前瞻性声明

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.

本版本可能包含基于拜耳管理层当前假设和预测的前瞻性声明。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的实际未来业绩、财务状况、发展或业绩与此处给出的估计之间存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments..

这些因素包括拜耳网站www.Bayer.com上拜耳公开报告中讨论的因素。公司不承担更新这些前瞻性声明或使其符合未来事件或发展的任何责任。。

References

参考文献

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1贝克，FC；德赞博蒂，M；Colrain，IM等人（2018）。更年期过渡期间的睡眠问题：患病率，影响和管理挑战。Nat Sci睡眠；10： 73-95岁。

2 Simon, JA; Anderson, RA; Ballantyne, E, et al. (2023). Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause; 30 (3): 239–246.

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3 Nappi, RE; Kroll, R; Siddiqui, E, et al. (2021). Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause; 28 (8): 875–882.

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4 Nappi, RE; Simoncini, T (2021). Menopause transition: a golden age to prevent cardiovascular disease. Lancet Diabetes Endocrinol; 9 (3): 135–137.

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