Elinzanetant has displayed positive top-line safety and efficacy results for managing moderate to severe vasomotor symptoms (VMS), according to Bayer.
Takeaways
- Elinzanetant has shown positive top-line safety and efficacy in managing moderate to severe vasomotor symptoms (VMS) in menopausal women.
- Approximately 80% of menopausal women experience VMS, with over one-third experiencing severe symptoms, which significantly affects their quality of life.
- The number of women experiencing menopause is expected to rise to 1.2 billion by 2030, underscoring the importance of addressing VMS for maintaining functional ability and quality of life.
- Elinzanetant is an oral medication that functions as a dual neurokinin-1,3 (NK-1,3) receptor antagonist. It modulates KNDY neurons, which become abnormal because of decreasing estrogen levels, thus managing VMS and reducing related sleep disturbances.
- The OASIS 1 and 2 phase 3 studies evaluated the safety and efficacy of elinzanetant. These studies included 396 and 400 participants, respectively, aged between 40 to 65 years. The trials demonstrated a significant reduction in VMS frequency, improvements in sleep disturbance and quality of life related to menopause, and a consistent safety profile.
VMS, linked to a decrease in estrogen levels causing hyperactivation of the thermoregulatory pathway, impacts approximately 80% of menopausal women. Severe symptoms are reported by over one-third of menopausal women, significantly impacting quality of life.
The number of women experiencing menopause is projected to increase to 1.2 billion by 2030, according to a press release of Bayer. VMS are the most common and disruptive symptoms of menopause reported, making addressing them vital to maintain functional ability and quality of life.
Elinzanetant is an oral dual neurokinin-1,3 (NK-1,3) receptor antagonist taken once per day. By modulating the KNDY neurons which become hypertrophic as estrogen levels decrease, elinzanetant may manage VMS and decrease associated sleep disturbances.
The safety and efficacy of elinzanetant were evaluated in the OASIS 1 and 2 (NCT05042362 and NCT05099159) phase 3 studies.Both trials are part of the OASIS clinical development program, a series of studies evaluating elinzanetant against VMS caused by menopause or endocrine therapy. There were 396 participants aged 40 to 65 years in the OASIS 1 study and 400 in the OASIS 2 study.
A significant reduction in VMS frequency from baseline to week 1, significant improvements in sleep disturbance and menopause-related quality of life, and a consistent safety profile with previous elinzanetant data were all observed across both studies. Efficacy endpoints were significantly improved compared to placebo.
"The most interesting finding of the study was that both OASIS 1 and 2 showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week 1," said James A. Simon, MD, CCD, MSCP, IF, FACOG, clinical professor at George Washington University and medical director and founder of IntimMedicine Specialists. "That means many women are seeing an impact right away without a long delay."
Reference
Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies. Bayer. January 8, 2024. Accessed January 8, 2024. https://www.bayer.com/media/en-us/bayers-elinzanetant-meets-all-primary-and-key-secondary-endpoints-in-pivotal-oasis-1-and-2-phase-iii-studies/
