Menopause Management: Bayer's Non-Hormonal Treatment Option Shows Efficacy In Trial

Monday, Bayer AG BAYZF announced topline results of Phase 3 studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. 

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, as a non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions 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 and statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. 

Also Read: Legal Victory For Bayer: Roundup Lawsuit Ends Five-Trial Losing Streak.

The safety profile observed in the OASIS 1 and 2 studies is consistent with previously published data on elinzanetant.

OASIS 1 and 2 randomized 396 and 400 postmenopausal women.

In November, Bayer stopped the OCEANIC-AF Phase 3 study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke.

The decision is based on the study's Independent Data Monitoring Committee (IDMC) recommendation as part of ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm. 

Last Thursday, Bayer and Asklepios BioPharmaceutical Inc completed an 18-month data collection in the Phase Ib trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for Parkinson's disease (PD). The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

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