Elinzanetant Data from Bayer Feature Prominently at 19th World Congress on Menopause

The range of the impact and burden of symptoms of menopause will be explored during oral and poster presentations as well as scientific symposia given by Bayer at the 19th World Congress on Menopause by the International Menopause Society, taking place October 19 – 22, in Melbourne, Australia, the company announced today.¹ (See full list below)

Two oral presentations and multiple posters at the Congress will focus on sleep disturbances during the menopausal transition. Sleep disturbances affect between 40% and 60% of women during menopause,² placing them on par with vasomotor symptoms (VMS, aka hot flashes) among the most frequent and also the most disruptive symptoms experienced during the transition, according to Bayer.¹ The company is conducting an exploratory phase 2 randomized parallel group treatment study (NIRVANA) exploring the efficacy of elinzanetant, the company’s investigational once-daily oral nonhormonal treatment for moderate to severe VMS, on menopause-related sleep disturbances. Data presented during poster sessions at the World Congress will explore the effects of sleep disturbance during menopause on depression and anxiety and on health-related quality of life.¹

The research is timely. The effects of interrupted overnight sleep include impaired alertness and activity during the day as well as negative impacts on metabolism, body fat, cardiovascular health, and cognitive and emotional health.^3,4 By 2030, the global population of women in menopause is expected to reach 1.2 billion, with 47 million women entering this endocrine transition annually.¹

Additional presentations during the IMS Congress include a pooled analysis as well as several subgroup analyses from the pivotal OASIS-1 and -2 phase III studies of elinzanetant, the first dual neurokinin-1 and -3 receptor antagonist in late-stage clinical development. The US FDA in early October accepted Bayer’s New Drug Application (NDA) for elinzanetant and has set a Prescription Drug User Fee Act date for July 26, 2025.

Findings from the phase 3 OASIS clinical trial program, the basis for the NDA, showed that elinzanetant reduced both VMS frequency and severity at week 4 and week 12 among postmenopausal women aged 40 to 65 years. The trial investigators also reported statistically significant changes at week 12 in the 2 key secondary endpoints, decreased sleep disturbance and improvement in menopause-related quality of life, compared to placebo.⁵ Improvements across primary and secondary endpoints were maintained throughout 52 weeks in a study of the long term safety and efficacy of elinzanetant. The positive findings on the secondary endpoints served as the springboard for the ongoing phase 2 NIRVANA trial.¹

Additional posters will provide results of subgroup analyses from the OASIS-1 and OASIS-2 phase 3 studies report data on the effects of elinzanetant on VMS across racial and ethnic groups, across BMI levels and smoking history, according to the announcement.¹

The elinzanetant purported mechanism of action, modulation of estrogen-sensitive hypothalamic KNDy neurons that hypertrophy with estrogen depletion, could explain the impact on moderate to severe VMS as well as improvements observed in sleep disruption.⁵

Up to 80% of women experience VMS at some point during menopause. Yet despite the impact of menopausal symptoms on their health, “less than 15% of women are being treated [for VMS], and it's an issue on both sides," OASIS 1 and 2 lead investigator JoAnn Pinkerton, MD, said in a recent interview with Patient Care.⁶ The 2 sides she refers to are women and their health care professionals. "Women do not need to suffer in silence,” Pinkerton stresses, pointing to clinician hesitancy and patient perceptions about the safety of different treatment options as barriers to effective care.⁶

Elinzanetant Data to be Presented

• Oral presentation: “Vasomotor symptoms and the impact of sleep disturbance associated with menopause among postmenopausal women in Europe”
• Oral presentation: “Exploring Sleep Disturbances Across Age and Sex with Wearable Smartwatches”
• Scientific Symposia: “Looking Beyond VMS: Sleep disturbances in the menopause”
• Poster # P037: “Does sleep disturbance have an impact on depression and anxiety in perimenopausal and postmenopausal women? A Europe-based survey”
• Poster # P047: “Frequency and co-occurrence of vasomotor symptoms, mood changes, and sleep disturbances across the menopausal transition: a descriptive study using secondary data from the Study of Women's Health Across the Nation (SWAN) study”
• Poster # P054: “EMPOWER: Evaluating Menopausal symPtom treatment Options and WomEns’ pReferences”
• Poster # P067: “Proportion of participants achieving at least 50%, 75% or 100% reductions in VMS frequency with elinzanetant in a pooled analysis of OASIS 1 and 2”
• Poster # 070: “Effect of elinzanetant for the treatment of vasomotor symptoms associated with menopause across race and ethnicity subgroups: pooled data from two Phase 3 studies”
• Poster # 071: “Effect of elinzanetant for the treatment of vasomotor symptoms associated with menopause across BMI and smoking history subgroups: pooled data from two Phase 3 studies”
• Poster # P161: “Design of the ESTeeM Study: Assessing the Burden, Treatment Patterns, and Unmet Needs of Sleep Disturbances in Menopausal Women”
• Poster # P163: “Effect of elinzanetant, an NK-1/NK-3 receptor antagonist, on patient-reported sleep disturbance: findings from two pivotal phase 3 studies”
• Poster # P166: “Impact of sleep disturbances on health-related quality of life in post-menopausal women”

References

1. Bayer to present latest research on impact and burden of menopause symptoms at IMS 2024. News release. Bayer. October 17, 2024. Accessed October 17, 2024. https://www.bayer.com/media/en-us/bayer-to-present-latest-research-on-impact-and-burden-of-menopause-symptoms-at-ims-2024/
2. 1 Baker FC, de Zambotti M, Colrain IM, et al. Sleep problems during the menopausal transition: prevalence, impact, and management challenges. Nat Sci Sleep. 2018;10:73–95. doi:10.2147/NSS.S125807
3 Nappi RE, Simoncini T. Menopause transition: a golden age to prevent cardiovascular disease. Lancet Diabetes Endocrinol. 2021;9(3): 135–137. doi: 10.1016/S2213-8587(21)00018-8.
4 Proserpio P, Marra S, Campana C, et al. Insomnia and menopause: a narrative review on mechanisms and treatments. Climacteric. 2020;23(6):539-549. doi:10.1080/13697137.2020.1799973
5. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. Published online August 22, 2024. doi:10.1001/jama.2024.14618