Elinzanetant, an investigational non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, has shown promising results in the pivotal Phase III OASIS 1 and 2 studies. The data, published in The Journal of the American Medical Association (JAMA), highlights the compound’s efficacy in reducing the frequency and severity of hot flashes, commonly referred to as vasomotor symptoms (VMS), while also improving sleep disturbances and quality of life for menopausal women.
Elinzanetant, the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development, demonstrated significant reductions in VMS. In the OASIS 1 study, participants experienced a 55.9% reduction in VMS frequency from baseline to week 4 and a 65.2% reduction by week 12. Similar results were seen in the OASIS 2 study, with a 57.9% reduction by week 4 and 67.0% by week 12. These improvements were significantly greater than those observed in the placebo group.
The studies also showed that over 80% of participants in the elinzanetant group achieved at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12. Furthermore, elinzanetant showed a rapid onset of action, with statistically significant reductions in VMS frequency as early as week 1.
“Due to individual risk factors, medical contraindications, or personal preference, there is an unmet need for additional safe and effective non-hormonal treatments for vasomotor symptoms associated with menopause that may also improve sleep disturbances and quality of life,” said Dr. JoAnn Pinkerton, Professor and Director of Midlife Health at UVA Health. “These positive results from OASIS 1 and 2 reinforce elinzanetant as a potential non-hormonal treatment option for women experiencing vasomotor symptoms in menopause.”
In addition to reducing hot flashes, elinzanetant also improved sleep disturbances, a common complaint among menopausal women. The treatment brought participants’ sleep disturbance scores from moderate to within the normal range, while those in the placebo group only improved to the mild disturbance range. The drug also showed significant improvements in menopause-related quality of life compared to placebo.
“Women experiencing menopause need treatment options that can help reduce the impact of symptoms on their quality of life,” said Dr. James A. Simon, Clinical Professor of Obstetrics and Gynecology at George Washington University. “The results from OASIS 1 and 2 are very promising when looking to address the unmet needs many women may experience during the menopause transition.”
The safety profile of elinzanetant was favorable, with headache and fatigue being the most commonly reported side effects. Importantly, no liver toxicity was observed. Additional safety data will be forthcoming from the 52-week OASIS 3 Phase III study.
Bayer, the company behind elinzanetant, has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe VMS based on these Phase III results. Applications for marketing authorization will also be submitted to other health authorities globally.
The Phase III clinical development program for elinzanetant includes four studies (OASIS 1, 2, 3, and 4), with the OASIS 4 study focusing on women experiencing VMS due to endocrine therapy for breast cancer. Bayer is also conducting an exploratory Phase II study, NIRVANA, to further investigate the drug’s impact on sleep disturbances in menopausal women.
As the global population of women experiencing menopause is projected to increase significantly, with 47 million women entering menopause each year by 2030, the need for effective treatments like elinzanetant is becoming increasingly important. The positive results from the OASIS studies position elinzanetant as a promising new option for addressing the often debilitating symptoms associated with menopause.
