Bayer's menopause treatment meets primary goals in final trial

Bayer has announced promising detailed data from a Phase 3 trial for its non-hormonal menopause treatment candidate, elinzanetant. This drug is being developed to address menopause symptoms such as hot flashes and night sweats. The OASIS 3 trial successfully met its primary goal by showing a statistically significant reduction in moderate to severe vasomotor symptoms from baseline to week 12 when compared to a placebo. These findings are set to be presented at The Menopause Society’s annual meeting in Chicago.

In the OASIS 3 trial, after 12 weeks of treatment, those in the elinzanetant group experienced a decrease in vasomotor symptoms to 1.6 events, compared to 3.4 events in the placebo group. These symptom reductions were sustained throughout the 52-week duration of the study. Additionally, patients on elinzanetant also reported improved sleep quality.

Based on the encouraging results from this trial and two other late-stage studies, OASIS 1 and OASIS 2, Bayer submitted a New Drug Application (NDA) to the FDA for elinzanetant in August. The company also plans to seek approval from other regulatory bodies and aims to launch the drug by 2025. Initial topline data for OASIS 3 was released by Bayer in March.

Common side effects observed in the elinzanetant group included headaches and Covid-19, but importantly, there were no signs of liver toxicity, endometrial hyperplasia, or endometrial malignant neoplasms.

James Simon, a study author and clinical professor of obstetrics and gynecology at George Washington University, emphasized the importance of long-term studies like OASIS 3, particularly for this class of drugs. Elinzanetant is a dual neurokinin-1 and -3 receptor antagonist and represents a novel approach in the late-stage development of treatments for menopausal vasomotor symptoms. The drug is administered orally once a day.

Simon highlighted that safety has been a significant concern for this class of drugs, as other neurokinin modulators have faced safety issues and failed to progress to clinical testing. Those that have reached the market have had to undergo labelling changes due to minor or mild safety concerns.

JoAnn Pinkerton, another study author and division director of the Midlife Health Center at UVA Health in Charlottesville, VA, stated that elinzanetant could serve as a new treatment option for menopausal women who either cannot or choose not to use hormone therapies. She pointed out that another ongoing Phase 3 trial, OASIS 4, is examining the drug's efficacy in women at high risk for breast cancer or those who have had breast cancer. These patients are typically on endocrine therapy to either prevent or treat breast cancer.

Pinkerton stressed the need for effective treatments for women who are unable to take hormone therapy due to risks of breast cancer, stroke, blood clots, or migraines. She noted that these women have had limited treatment options up to now, making the potential approval of elinzanetant particularly significant.

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