Results from Phase III Duo Show Elinzanetant Significantly Reduced Frequency and Severity of Hot Flashes Associated with Menopause
The pivotal Phase III OASIS 1 and 2 studies both met all primary endpoints with elinzanetan reducing symptoms over 12 weeks compared to placebo.
Full data for the duo of Phase III studies—OASIS 1 and 2—has been published in The Journal of the American Medical Association (JAMA). The trials evaluated the efficacy and safety of the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS), or hot flashes, associated with menopause.1
According to Bayer, elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.
In May, Bayer shared initial data from the trials, which showed elinzanetant achieved a statistically significant reduction in frequency and severity of VMS over 12 weeks compared to placebo. Both studies met all primary endpoints.2
“There are limited approved non-hormonal treatments for bothersome menopausal symptoms, such as hot flashes and sleep disturbances. Consequently, many women experience discomfort for months or even years, with the majority of symptoms left untreated,” JoAnn Pinkerton, MD, professor and director of Midlife Health at UVA Health said in an earlier press release. “These results are exciting news for women who suffer from moderate to severe hot flashes and build on our confidence that elinzanetant may be a potential non-hormonal solution for them.”
The more detailed data published in JAMA show results from both trials are in line with the Phase II SWITCH study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.
Similar results were seen in both OASIS studies. In OASIS 1, the frequency of VMS was reduced by 55.9% from baseline to week 4 and 65.2% to week 12, compared to reductions of 31.4% and 42.2% respectively for placebo. In OASIS 2, results showed a reduction of 57.9% to week 4 and 67.0% to week 12, compared to reductions of 35.7% and 45.9% respectively in the placebo group.
OASIS 1 and 2 (NCT05042362 and NCT05099159) are double-blind, randomized, placebo-controlled multicenter studies. Nearly 800 women between the ages of 40 and 65 participated across both studies. Patients were randomized to receive a 120 mg dose of elinzanetant once daily for 26 weeks or a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. There is also an OASIS 3 study (NCT05030584), which investigated the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks in postmenopausal women.
Earlier in August, Bayer submitted an NDA (New Drug Application) to the FDA for elinzanetant for the treatment of moderate to severe VMS associated with menopause.3
“Half of the world’s population will experience menopause, with 27 million women in the US currently experiencing this transition. Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limitations of treatment options available,” Christine Roth, executive vice president, global product strategy and commercialization, member of the pharmaceutical leadership team at Bayer, said in a press release. “The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women. This further underscores our position as leaders in Women's Health and our dedication to addressing the unmet medical needs of women globally.”
References
1. The Journal of American Medical Association (JAMA) publishes Elinzanetant Phase III data. News release. Bayer. August 22, 2024. Accessed August 22, 2024. https://www.businesswire.com/news/home/20240822839833/en/The-Journal-of-American-Medical-Association-JAMA-publishes-Elinzanetant-Phase-III-data
2. Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause. News release. Bayer. May 16, 2024. Accessed August 22, 2024. https://www.businesswire.com/news/home/20240516573881/en/Elinzanetant-significantly-reduces-frequency-and-severity-of-moderate-to-severe-hot-flashes-associated-with-menopause
3. Bayer Submits New Drug Application to U.S. FDA for Elinzanetant for the Treatment of Moderate to Severe Vasomotor Symptoms Associated With Menopause. News release. Bayer. August 1, 2024. Accessed August 22, 2024. https://www.businesswire.com/news/home/20240801301402/en/Bayer-Submits-New-Drug-Application-to-U.S.-FDA-for-Elinzanetant-for-the-Treatment-of-Moderate-to-Severe-Vasomotor-Symptoms-Associated-With-Menopause
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