Bayer Announces Positive Topline Results from Two Pivotal Phase III OASIS Trials of First-in-Class NK1/3 Receptor Antagonist Elinzanetant for Menopausal Vasomotor Symptoms

On January 12, Bayer announced positive topline results from the pivotal Phase III clinical studies OASIS 1 and 2 of Elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause in women.

Elinzanetant is the first-in-class dual neurokinin-1,3 (NK-1,3) receptor antagonist currently in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. It addresses moderate to severe VMS by modulating a group of estrogen-sensitive neurons (KNDy neurons) in the hypothalamus of the brain. In menopausal women, KNDy neurons become overactive due to estrogen deficiency, disrupting the body's temperature regulation mechanism and leading to vasomotor symptoms such as hot flashes. Elinzanetant can also reduce sleep disturbances associated with menopause.

OASIS 1 and 2 studies aim to evaluate the efficacy and safety of Elinzanetant compared with placebo. Both clinical trials successfully met all four primary endpoints, showing a statistically significant reduction in the frequency and severity of moderate to severe VMS from baseline to Week 4 and Week 12 in the treatment group compared with placebo.

The two studies also met three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to Week 1 in the treatment group compared with placebo. Statistically significant improvements were also observed in sleep disturbance and menopause-related quality of life. The safety profile observed in the OASIS 1 and 2 studies was generally consistent with previously published data.

Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development, stated: "We are encouraged by the positive results of the two pivotal Phase III clinical trials for elinzanetant, which enhance its potential as a non-hormonal treatment option for menopause management. We would like to thank the female participants in the OASIS study, their families, all researchers, and their clinical and nursing staff for their time and commitment to advancing menopause research."

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