Bayer shares phase 3 trial wins for menopause symptom drug
17 May 2024
Clinical ResultPhase 3Drug Approval
Bayer's investigational compound, elinzanetant, significantly reduced frequency and severity of vasomotor symptoms (hot flashes) associated with menopause in a pair of phase 3 trials.
Elinzanetant, which offers non-hormonal treatment, successfully met all four primary endpoints in the OASIS 1 and 2 studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS) from baseline to week 4 and 12 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.
Back in March, Bayer announced positive topline results for the third phase 3 study, OASIS 3, in the OASIS clinical development program. In this study, elinzanetant reduced the frequency of hot flashes from baseline to week 12 compared to placebo.
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist, administered orally once daily. The drug is designed to address VMS by modulating a group of estrogen-sensitive neurons in the hypothalamus region of the brain which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, which disrupts body heat control.
Bayer plans to submit the data from the three OASIS studies to regulatory authorities for marketing approval.
If approved, elinzanetant will join Astellas' Veozah in the menopause symptoms space. Astellas won approval for the once-daily pill, a neurokinin 3 (NK3) receptor antagonist, a year ago. Veozah was the first non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.
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