Bayer has unveiled positive top-line outcomes from the pivotal Phase III studies, OASIS 1 and 2, assessing the efficacy and safety of the investigational compound Elinzanetant compared to a placebo. Elinzanetant achieved success in meeting all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, commonly known as hot flashes) from baseline to weeks 4 and 12 compared to the placebo.
Furthermore, both studies accomplished all three key secondary endpoints, exhibiting a statistically significant reduction in the frequency of VMS from baseline to week 1. Additionally, there were statistically significant improvements observed in sleep disturbances and menopause-related quality of life compared to the placebo. The safety profile observed in the OASIS 1 and 2 studies aligns with previously published data on Elinzanetant.
Dr. Christian Rommel, a member of the Executive Committee of Bayer AG's Pharmaceutical Division and Global Head of Research and Development, expressed enthusiasm about the positive results, stating, "We are excited about the positive results of these two pivotal Phase III studies for Elinzanetant, reinforcing its potential as a non-hormonal treatment option in menopause management."
Elinzanetant, an orally administered first dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause.
Dr. JoAnn Pinkerton, Professor and Director of Midlife Health at UVA Health, highlighted the importance of addressing the unmet needs of women experiencing disruptive menopausal symptoms. She stated, "It’s important that we continue to research for solutions that address the unmet needs of women, and I am looking forward to the unveiling of the full results."
OASIS 1 and 2 (NCT05042362 and NCT05099159) represent the first two Phase III studies in the OASIS clinical development program, with detailed results scheduled for presentation at upcoming scientific congresses. The results of the third Phase III study, OASIS 3 (NCT05030584), are anticipated in the coming months. Bayer plans to submit data from the OASIS 1, 2, and 3 studies to health authorities for approval of marketing authorizations for the treatment of moderate to severe VMS associated with menopause.