The non-hormonal menopause therapy market may get a boost soon as Bayer’s elinzanetant met primary and secondary endpoints in two pivotal Phase III trials. The drug significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VSM), commonly known as hot flashes, in post-menopausal women.
Neurokinin receptors help regulate the hypothalamus-pituitary-adrenal (HPA) axis, which is responsible for hormone regulation. VMS are due to hyperactivation of the thermoregulatory pathway caused by a decrease of estrogen, usually due to the progressive reduction of ovarian function.
Elinzanetant is a dual neurokinin (NK)-1,3 receptor antagonist. Its main competitor is Astellas’ Veozah (fezolinetant), a NK-3 receptor antagonist. The U.S. Food and Drug Administration (FDA) approved Veozah as a treatment for hot flashes in May 2023 and the drug netted almost $50 in sales that year.
By 2030, it is projected there will be 47 million women worldwide entering menopause. Hormonal therapies are often used to treat VSM, but they increase the risk of heart attacks, strokes, and breast cancer. Non-hormonal menopause treatment, such as Veozah and elinzanetant, are expected to comprise a $2B+ market in just a few years.
“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,” said JoAnn Pinkerton, MD, professor and director of Midlife Health at UVA Health. “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.”
Bayer’s OASIS I and II Phase III studies of elinzanetant achieved a statistically significant reduction in frequency and severity of VMS over 12 weeks compared to placebo. Consistent benefits were also seen across both studies in all three key secondary endpoints, with significant reduction in frequency of VMS at week one, and improvement in sleep disturbances and menopause-related quality of life. The safety profile in both studies was favorable.
Elinzanetant thus met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to week four and 12 compared to placebo. Both studies also achieved a statistically significant reduction in the frequency of VMS from baseline to week one, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
“The robust efficacy and favorable safety profile of elinzanetant reinforces its potential as a non-hormonal treatment for women experiencing menopause,” said Christian Rommel, member of the executive committee of Bayer AG’s Pharmaceutical Division and global head of research and development.
Earlier in March 2024, Bayer announced positive topline results for the third Phase III study OASIS 3, which randomized 628 postmenopausal women between 40 and 65 years across 83 sites in nine countries. Elinzanetant successfully met the primary endpoint demonstrating a statistically significant reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The long-term safety profile observed over 52 weeks in the OASIS 3 study is overall consistent with previously conducted studies and published data.
Up to 80% of women report VMS at some point during the menopausal transition and they are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.
