Bayer today announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2, evaluating the efficacy and safety profile of the investigational compound elinzanetant versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the mean change in frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flushes) from baseline to week 4 and 12 compared to placebo in postmenopausal women.
Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the mean change in 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 data1,2 on elinzanetant.
"We are excited about the positive results of these two pivotal Phase III studies for elinzanetant, reinforcing its potential as a non-hormonal treatment option in menopause management,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "We want to thank the women participating in the OASIS studies, their families, and all study investigators as well as their clinical and nursing staff for their time and commitment to advance menopause research."
Elinzanetant is a 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 in women, administered orally once daily. It has not been approved by any health authority for use in any country, for any indication.
“Menopausal symptoms such as hot flushes and sleep disturbances can be highly disruptive and broadly impact health and quality of life. Still many women cope in silence and remain untreated," says JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health. “It’s important that we continue to research for solutions that address the unmet needs of women, and I am looking forward to the unveiling of the full results.”
OASIS 1 and 2 (NCT05042362 and NCT05099159) are the first two Phase III studies in the OASIS clinical development programme with results, and the details are planned to be presented at upcoming scientific congresses. The results of the third Phase III study OASIS 3 (NCT05030584) are expected in the coming months.
Bayer media contact:
Veronica Yao, +44 (0) 7870 485 926
Notes to Editors
OASIS 1 and 2 are double-blind, randomised, placebo-controlled multicenter studies investigating the efficacy and safety profile of elinzanetant 120 mg administered orally once daily in women with moderate to severe VMS associated with menopause. OASIS 1 and 2 randomised 396 and 400 postmenopausal women between 40 and 65 years respectively across 184 sites in 15 countries. The co-primary endpoints in the studies were mean change in frequency of moderate to severe hot flush from baseline to Week 4 and 12.
About the OASIS Clinical Development Programme
The Phase III clinical development programme 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 profile of elinzanetant 120 mg once daily in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical phase III programme and investigates the efficacy and safety profile of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for the treatment or prevention of breast cancer.
The design and dosing of the Phase III clinical development programme 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 profile, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety profile of four different doses of elinzanetant compared to placebo in postmenopausal women with associated moderate to severe VMS.
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development as a non-hormonal treatment of moderate to severe VMS associated with menopause in women, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of oestrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of oestrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant is also being investigated in women with sleep disturbances associated with menopause.
About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flushes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of oestrogen, 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.3 Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period,3,4 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.5 For these women with VMS due to induced menopause, there are currently no licensed treatment options.
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.6Menopause 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.7 It can also be the result of surgical or medical treatment, for example breast cancer treatment.7 The hormonal decline can lead to various symptoms, which can substantially affect a woman’s health, quality of life, healthcare utilisation and work productivity.8 The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.8 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
Bayer is a recognised global leader in women’s healthcare with 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 gynaecological 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 programmes 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.
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. 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. For more information, go to www.bayer.co.uk.
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.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.
Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.
Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.
Angelo SD, et al. Impact of Menopausal Symptoms on Work: Findings from Women in the Health and Employment after Fifty (HEAF) Study. Int. J. Environ. Res. Public Health 2023, 20, 295. https://doi.org/10.3390/ijerph20010295.
Nancy E. Avis, et al. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 December ; 45(4): 629–640. doi:10.1016/j.ogc.2018.07.005.
Gucciniello L, et al. Estrogen deprivation effects of endocrine therapy in breast cancer patients: Incidence, management and outcome. Cancer Treatment Reviews 120 (2023) 102624. https://doi.org/10.1016/j.ctrv.2023.102624.
Kenneth Hill. The demography of menopause. Maturitas 23 (1996) 113-127. Journal of the Climacteric & Postmenopause. SSDI 0327-5122(95)00968-R.
Menopause. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/menopause. Last accessed: November 2023.
Wulf H Utian. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes 2005, 3:47 doi:10.1186/1477-7525-3-47