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Bayer Highlights Detailed Data From Twin Late-Stage Trials On Experimental Menopause Candidate, Seeks Regulatory Approval

Benzinga ·  May 17 23:02

Bayer AG (OTC:BAYRY) (OTC:BAYZF) will present detailed results from the Phase 3 studies OASIS 1 and 2, showing that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (hot flashes) associated with menopause compared to placebo.

The company released the topline data showing elinzanetant met all four primary endpoints in both studies.

These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting.

Related: German Conglomerate Bayer Goes Johnson & Johnson Way To Tackle Its Cancer Related Lawsuits.

Elinzanetant 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 and week 12 with -3.22 and for severity at week 4 with -0.33 and week 12 with -0.40.

In OASIS 2, elinzanetant demonstrated significant mean reductions versus placebo for frequency at week 4 with -3.04 and at week 12 with -3.24 and for severity at week 4 with -0.22 and at week 12 with -0.29.

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.

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.

In March, Bayer announced the topline results of the OASIS 3 Phase 3 study evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.

OASIS 3 is the third Phase 3 study in the OASIS clinical development program.

Bayer will submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for moderate to severe VMS associated with menopause.

Photo by ClareM via Shutterstock

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