Phase IIb Clinical Study of Investigational Compound Elinzanetant Evaluated Efficacy and Safety in Postmenopausal Patients with Vasomotor Symptoms Study Findings Published in Menopause: The Journal of The North American Menopause Society

• SWITCH-1 Phase IIb, was a multicenter, multicounty, double-blind, placebo-controlled, dose-range finding study with an adaptive randomization design evaluating elinzanetant in postmenopausal women aged 40-65 years.

Menopause: The Journal of the North American Menopause Society today published “Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1),” detailing the results of the SWITCH-1 clinical trial aimed at identifying effective dosing for the investigational compound elinzanetant, a non-hormonal, selective neurokinin 1,3 receptor antagonist.¹ This Phase IIb study demonstrated a statistically significant reduction in the frequency and severity of hot flashes compared to placebo at primary 4-week and 12-week endpoints (120 mg (week 4: −3.93 [SE, 1.02], P < 0.001; week 12: −2.95 [1.15], P = 0.01) and at week 4 for elinzanetant 160 mg (−2.63 [1.03]; P = 0.01).)¹ Overall, adverse events (AEs) were mild or moderate and there were no serious AEs related to treatment.¹ Further details about the study and its findings are below. Preliminary, top-line data were initially presented at the North American Menopause Society 2020 meeting in October 2020, and the 13^th European Congress on Menopause and Andropause Virtual Meeting in September 2021.

“While menopause is a natural part of aging for women, millions of women across the U.S. experience severe and bothersome hot flashes,^2,3 which last for an average of nearly seven-and-a-half years,⁴” said James A. Simon, M.D., clinical professor of obstetrics and gynecology at The George Washington University School of Medicine, Founder of IntimMedicine Specialists, and lead investigator on the SWITCH-1 study. “We are excited about the further exploration of elinzanetant as a potential non-hormonal option for women, especially as many women may not be candidates for existing hormone therapies because of medical contraindications or due to personal preferences.”

Key details and findings of the Phase IIb SWITCH-1 Study include, SWITCH-1 study met its primary endpoint by demonstrating reductions in VMS frequency and severity versus placebo at primary 4-week and 12-week endpoints: 120 mg (week 4: −3.93 [SE, 1.02], P < 0.001; week 12: −2.95 [1.15], P = 0.01) and at week 4 for elinzanetant 160 mg (−2.63 [1.03]; P = 0.01).¹ Study evaluated four different doses (40mg, 80mg, 120mg, 160mg), in the mean daily frequency of moderate-to-severe VMS with elinzanetant 120 mg at week 4 (difference in LS means [SE], −3.93 [1.02]; P < 0.001) and week 12 (−2.95 [1.15]; P = 0.01). The improvements with elinzanetant 160 mg were significant at week 4 (−2.63 [1.03];P = 0.01) but not week 12 (−1.78 [1.19]; P = 0.13).¹ Improvements with elinzanetant 40 mg and 80 mg were observed but not statistically significant compared with placebo at either of the primary endpoint time points.¹ The most common AEs were headache, somnolence, dizziness, diarrhea, nausea or fatigue.¹

Naturally occurring, menopause is defined as having transpired when a woman has experienced 12 consecutive months of amenorrhea (the absence of periods) and is usually identified retrospectively.⁵ Typically, naturally occurring menopause occurs in the early fifties, although this could vary depending on a variety of factors.⁶ By 2050, it is estimated that more than 1.6 billion women worldwide will have reached menopause or be postmenopausal – this is up from 1 billion in 2020.³ The hormonal changes that occur during menopause can affect multiple body systems and organs.⁵

“Standing for and advocating on behalf of women’s health is central to our “We’re for Her” mission at Bayer. For over 60 years, Bayer has been a leader in women’s healthcare and this commitment spans generations, from prenatal and newborn support to contraceptive access, and the menopause transition is no different,” said Yesmean Wahdan, M.D., Vice President US Medical Affairs, Bayer Women’s Healthcare. “Many women may experience a variety of symptoms of differing severity and duration, including vasomotor, psychological, urogenital, cardiovascular, and musculoskeletal symptoms.^5,7 We’re excited about moving into phase III studies investigating elinzanetant for the treatment of VMS.”

About Elinzanetant

Elinzanetant is an investigational compound and has not been approved by any health authority for use in any country, for any indication. Elinzanetant is an oral, once-daily, non-hormonal, selective neurokinin-1,3 (NK-1,3) receptor antagonist that is being studied for the reduction of vasomotor symptoms (VMS). Elinzanetant is currently in phase III clinical trials with a program based on the data from phase 2 RELENT-1 and SWITCH-1 studies. The data from SWITCH-1 supports launching the Phase III trial.

About the SWITCH-1 Study

SWITCH-1 Phase II was a double-blind, randomized, placebo-controlled study conducted across 25 sites in the USA, UK and Canada with 199 postmenopausal, female participants ages 40 through 65 who had been experiencing at least seven moderate or severe hot flashes per day. The findings observed in the SWITCH-1 Phase II study allowed Bayer to move forward with the clinical development program into Phase III studies. Elinzanetant is being investigated to determine safety and efficacy in women who have moderate to severe vasomotor symptoms.

About Women’s Healthcare at Bayer

Bayer is a recognized leader in the area of 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 menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide. Today, Bayer’s research and development efforts focus on finding new treatment options for menopause as well as gynecological diseases and includes several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated.

Additionally, Bayer intends to provide 100 million women 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. 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. 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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 confirm them to future events or developments.

References:

1. Simon J, et al. OR11-03 NT-814, a Non-Hormonal Dual Neurokinin 1,3 Receptor Antagonist Markedly Improves Vasomotor Symptoms in Post-Menopausal Women; Results of a Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study (SWITCH-1), Journal of the Endocrine Society. 2020; 4, Issue Supplement 1, OR1103 Supplement_1,OR1103. Available at: https://doi.org/10.1210/jendso/bvaa046.2071.
2. Peacock K, Ketvertis KM. Menopause. [Updated 2022 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available at: https://www.ncbi.nlm.nih.gov/books/NBK507826/
3. Zhang GQ, Chen JL, Luo Y, Mathur MB, Anagnostis P, Nurmatov U, et al. Menopausal hormone therapy and women's health: An umbrella review. PLoS Med. 2021;18(8):e1003731. Available at: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003731
4. Avis NE, Crawford SL, Greendale G, et al. Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition. JAMA Intern Med. 2015;175(4):531–539. doi:10.1001/jamainternmed.2014.8063. Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2110996
5. NICE. Menopause: diagnosis and management 2019 (December 2019). Available at: www.nice.org.uk/guidance/ng23
6. Gold EB, Crawford SL, Avis NE, Crandall CJ, Matthews KA, Waetjen LE, et al. Factors related to age at natural menopause: longitudinal analyses from SWAN. Am J Epidemiol. 2013;178(1):70-83. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3698989/pdf/kws421.pdf
7. Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause (New York, NY). 2021;28(8):875-82. Available at: https://pubmed.ncbi.nlm.nih.gov/34033602/

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