Tuesday, Bayer AG (OTC:BAYRY) (OTC:BAYZF) announced topline results of the Phase 3 study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
In this study, elinzanetant met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo.
The long-term safety profile observed over 52 weeks in the OASIS 3 study is consistent with previously conducted studies and published data on elinzanetant.
Elinzanetant is the 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.
OASIS 3 is the third Phase 3 study in the OASIS clinical development program.
In early 2024, Bayer announced topline data of the first two Phase 3 studies OASIS 1 and 2.
Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms 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 and statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
Reuters highlighted that Bayer previously estimated the blood-thinning drug could have peak annual sales of more than €5 billion, and the menopause drug elinzanetant was given the potential of about a billion dollars or more per year.
Last year, Acer Therapeutics Inc's (OTC:ACER) Phase 2a proof of concept clinical trial of ACER-801 (osanetant) as a potential treatment for moderate to severe VMS associated with menopause did not achieve statistical significance to decrease the frequency or severity of hot flashes in postmenopausal women.
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