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; also known as hot flashes) associated with menopause compared to placebo. In addition, elinzanetant met its key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improved sleep disturbances and menopause-related quality of life compared to placebo. These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting taking place from May 17 – 19 in San Francisco, CA, USA.

“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,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health.

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. Elinzanetant showed in OASIS 1 significant mean reductions versus placebo for frequency at week 4 with -3.29 (p<0.0001) and week 12 with -3.22 (p<0.0001) and for severity at week 4 with -0.33 (p<0.0001) and week 12 with -0.40 (p<0.0001). In OASIS 2, elinzanetant demonstrated significant mean reductions versus placebo 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) within the elinzanetant groups.

“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,” added Dr. Pinkerton.

Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1 (p<0.0001 and p=0.0013, respectively), as well as statistically 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 in the OASIS clinical development program evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo. In this study, elinzanetant successfully met the primary endpoint, 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 the OASIS 3 study is overall consistent with previously conducted studies and published data on elinzanetant. These results will be presented at upcoming scientific congresses.

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.