Bayer announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reduction in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the 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. Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the 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.

OASIS 1 and 2 (NCT05042362 and NCT05099159) are the first two Phase III studies in the OASIS clinical development program 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 plans to submit data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations for treatment of moderate to severe VMS associated with menopause.