Bayer to unveil late-breaking data from Phase III OASIS 1 and 2 for elinzanetant in the treatment of vasomotor symptoms associated with menopause

• Detailed results from pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of investigational compound elinzanetant will be presented for the first time at this year’s American College of Obstetricians and Gynecologists (ACOG)
• Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist being studied for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily
• Additional presentations include a variety of posters and oral presentations that span across Bayer’s contraception and menopause portfolio as well as two scientific symposia
• Presentations demonstrate Bayer’s long-standing commitment in women’s healthcare as the company continues to address relevant unmet medical needs for women

Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo, at the upcoming American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting. ACOG takes place from May 17 – 19, in San Francisco, CA, United States.

Additional presentations will feature new findings from Bayer’s intrauterine systems (IUS) and menopause product portfolio, as well as a scientific symposium session on the science behind menopause symptoms. These presentations demonstrate Bayer’s long-standing commitment to advance women’s healthcare as the company works towards broadening treatment options for women.

OASIS 1 and 2 data presentations:

• Scientific Symposium: OASIS 1 and 2: Elinzanetant Efficacy and Safety Data From 2 Pivotal Studies
  • James A. Simon, MD and JoAnn V. Pinkerton, MD
  • Friday, 17 May, 5:15 – 6:00 PM PST, Location: 154

• E-Poster #IP05-C: First Phase 3 trial evaluating the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause (OASIS 2)
  • JoAnn V. Pinkerton, MD
  • Saturday, 18 May, 9:30 – 10:30 AM PST, Location: Hall C

• E-Poster #IP05-D: Second Phase 3 trial OASIS 1 confirms efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause
  • James A. Simon, MD
  • Saturday, 18 May, 09:30 – 10:30 AM PST, Location: Hall C

Additional Bayer presentations include:

• Scientific Symposium: Understanding Menopause: The Science Behind the Symptoms
  • JoAnn V. Pinkerton, MD and Victor Navarro, MD
  • Saturday, 18 May, 7:00 – 7:45 AM PST, Location: 153
    
    
    
    
• E-Poster #IP01-A: LNG-IUS for the Treatment of Endometrial Hyperplasia and Early-stage Endometrial Cancer: a Systematic Review and Meta-analysis
  • Kristina Rosa Cruz Bolling, PhD
  • Friday, 17 May, 10:30 – 11:30 AM PST, Location: Hall C
    
    
    
    
• E-Poster #IP01-B: Treatment and clinical characteristics of perimenopausal and menopausal women with vasomotor symptoms (VMS): a real-world data analysis
  • Lena Charafi, DPharm
  • Friday, 17 May, 10:30 – 11:30 AM PST, Location: Hall C

About the OASIS 1, 2 and 3 studies

OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. OASIS 3 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. OASIS 3 randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

Bayer will submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause.

About the Elinzanetant Clinical Development Program

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.

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.

In addition to the OASIS program, Bayer started NIRVANA (NCT06112756), 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 as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant

Elinzanetant is the 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 may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as 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. 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.

About Women’s Healthcare at Bayer

Women’s Health is in Bayer’s DNA. 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. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in 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 for capacity building and by ensuring the supply of affordable modern contraceptives. 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.

About Bayer

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. 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

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. 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.

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