New data from two late-stage studies of an experimental Bayer drug show it reduced the frequency and severity of common symptoms of menopause, supporting the company’s case for seeking regulatory approval.
The results were disclosed by Bayer Thursday and will be presented at this year’s annual meeting of the American College of Obstetricians and Gynecologists in San Francisco.
Bayer shared the trials’ success in January, but didn’t reveal specific findings. The company also announced positive results from a third Phase 3 study in March, when it confirmed plans to file for marketing authorization of the drug.
Known as elinzanetant, Bayer’s drug would, if approved, compete with a medicine from Astellas called Veozah, which is approved in the U.S. to treat moderate-to-severe vasomotor symptoms caused by menopause.
Often described as hot flashes, vasomotor symptoms commonly occur during menopause, the natural period when a woman’s menstrual cycle stops. Caused by the resulting decrease in estrogen levels, symptoms can last for many years and are severe for some women.
Hormonal therapies are sometimes used to treat vasomotor symptoms, but they may increase the risk of heart attacks, blood clots and breast cancer. The Food and Drug Administration recommends that, if prescribed, hormone therapies be taken at the lowest dose and for as short a time as possible.
“There are limited approved non-hormonal treatments for bothersome menopausal symptoms, such as hot flashes and sleep disturbances,” said JoAnn Pinkerton, professor and director of midlife health at UVA Health, in a statement provided by Bayer. “Consequently, many women experience discomfort for months or even years, with the majority of symptoms left untreated.”
With its approval last year, Veozah became the first drug that works by blocking a protein known as neurokinin 3, or NK3, that’s involved in regulating body temperature.
Bayer’s drug works along the same lines. Also a neurokinin receptor antagonist, elinzanetant targets the NK1 and NK3 receptors.
In the Oasis 1 and Oasis 2 studies, Bayer respectively enrolled 396 and 400 postmenopausal women between the ages of 40 and 65 years with moderate to severe vasomotor symptoms. Women either received a once-daily dose of elinzanetant or placebo, and were evaluated over 26 weeks.
From Oasis 1, Bayer reported treatment led to an average reduction of 3.29 occurrences of vasomotor symptoms at week 4, and of 3.22 at week 12, as recorded by a hot flash daily diary. The reductions Bayer reported are adjusted for placebo, a spokesperson confirmed. Significant decreases in symptom severity were also reported at weeks 4 and 12, compared to placebo.
In Oasis 2, elinzanetant treatment reduced the frequency of symptom occurrence by an average of 3.04 at week 4 and by 3.24 at week 12. Participants in this study also reported significant lessening of severity, compared to those on placebo.
Bayer added that women in the studies reported improvement in sleep disturbances and in “menopause-related quality of life.”
In the two studies Astellas used to support Veozah’s approval, its drug led to placebo-adjusted reductions in the frequency of vasomotor symptoms by an average of 2.5 and 2.6 at week 12.
Oasis 3, the study Bayer in March said succeeded, is evaluating elinzanetant in 628 postmenopausal women over 52 weeks. The company hasn’t yet detailed its findings in full, but said treatment similarly led to significant declines in the frequency of symptoms, compared to placebo.
Headache and fatigue were the most commonly reported side effects associated with treatment among those given elinzanetant, Bayer said.
“These results … build on our confidence that elinzanetant may be a potential non-hormonal solution for [women],” said Pinkerton.
Bayer acquired the rights to elinzanetant via a $425 million buyout of biotechnology company KaNDy Therapeutics in 2020. In a March presentation, Bayer’s head of its pharmaceutical division Stefan Oelrich described the drug as a “potential blockbuster.”
However, it might face an uphill commercial battle in competing with Veozah. Astellas has reported low demand and difficulty securing insurer reimbursement.
Bayer plans to submit data from the three Oasis studies in the coming months.
