Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, showing that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause compared to placebo.

Additionally, elinzanetant met its key secondary endpoints by showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improvements in sleep disturbances and menopause-related quality of life. These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting from May 17 – 19 in San Francisco, CA, USA.

Elinzanetant successfully met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to week 4 and 12 compared to placebo. In OASIS 1, significant mean reductions versus placebo were observed for frequency at week 4 with -3.29 (p<0.0001) and at week 12 with -3.22 (p<0.0001), and for severity at week 4 with -0.33 (p<0.0001) and at week 12 with -0.40 (p<0.0001). In OASIS 2, significant mean reductions versus placebo were observed for frequency at week 4 with -3.04 (p<0.0001) and at week 12 with -3.24 (p<0.0001), and for severity at week 4 with -0.22 (p=0.0003) and at week 12 with -0.29 (p<0.0001). The safety profile of elinzanetant was favorable in both studies, with headache and fatigue being the most frequent treatment-emergent adverse events (TEAEs).

“There are limited approved non-hormonal treatments for bothersome menopausal symptoms, such as hot flashes and sleep disturbances. Consequently, many women experience discomfort for months or even years, with the majority of symptoms left untreated,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health. “These results are exciting news for women who suffer from moderate to severe hot flashes and build on our confidence that elinzanetant may be a potential non-hormonal solution for them.”

Both studies also achieved statistically significant reductions in the frequency of VMS from baseline to week 1 (p<0.0001 and p=0.0013, respectively), as well as significant improvements in sleep disturbances (p<0.0001 in both studies) and menopause-related quality of life (p<0.0001 and p=0.0059, respectively) compared to placebo.

“The robust efficacy and favorable safety profile of elinzanetant reinforces its potential as a non-hormonal treatment for women experiencing menopause,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We look forward to submitting applications to health authorities for marketing authorizations of elinzanetant to treat moderate to severe VMS associated with menopause, building upon our extensive legacy and commitment to women’s healthcare.”

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.

Earlier in March 2024, Bayer announced positive topline results for the third Phase III study OASIS 3, which evaluates the efficacy and long-term safety of elinzanetant versus placebo. In this study, elinzanetant met the primary endpoint by demonstrating a statistically significant reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The long-term safety profile observed over 52 weeks in OASIS 3 is consistent with previously conducted studies and published data on elinzanetant. These results will be presented at upcoming scientific congresses.

Bayer will submit 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 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. Patients in the elinzanetant arm received a 120 mg dose once daily for 26 weeks, while patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks. OASIS 3 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant over 52 weeks in postmenopausal women, involving 628 women between 40 and 65 years across 83 sites in 9 countries.

About the Elinzanetant Clinical Development Program

The Phase III clinical development program of elinzanetant, OASIS, includes 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. OASIS 4 expands the program, investigating elinzanetant in women with moderate to severe VMS caused by endocrine therapy for breast cancer treatment or prevention.

The design and dosing of the Phase III program are based on 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.

Additionally, Bayer initiated NIRVANA, an exploratory Phase II randomized, parallel-group, double-blind study to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography (PSG).

About Elinzanetant

Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist in late-stage clinical development for non-hormonal treatment of moderate to severe VMS associated with menopause. It is administered orally once daily and may address VMS by modulating estrogen-sensitive neurons in the hypothalamus that become hypertrophic with the decrease of estrogen, leading to hyperactivation of the thermoregulatory pathway and resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of KNDy neurons due to decreased estrogen. VMS are reported by up to 80% of women during menopause and can significantly impact quality of life. Severe symptoms can last for over a decade after the last menstrual period. Endocrine therapy for breast cancer can also cause VMS, impacting quality of life and treatment adherence.

About Menopause

By 2030, the global population of women experiencing menopause is projected to reach 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives due to the decline of ovarian function, typically occurring in their 40s or early 50s. Symptoms such as VMS, sleep disturbances, and mood changes can significantly affect health, quality of life, and productivity.

About Women’s Healthcare at Bayer

Bayer has a long-standing commitment to advancing women’s healthcare, offering a range of birth control methods and therapies for menopause management and gynecological diseases. Bayer aims to provide 100 million women per year in low-and-middle-income countries with access to family planning by 2030. This commitment aligns with the United Nations Sustainable Development Goals.