Elinzanetant

Bayer touted more detailed data from a Phase 3 trial for elinzanetant, a non-hormonal drug candidate that it’s investigating as a treatment for menopause symptoms like hot flashes and night sweats. The OASIS 3 trial hit the primary endpoint of demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms from baseline to week 12 compared to placebo, according to results set to be presented Tuesday at The Menopause Society’s annual meeting in Chicago. After 12 weeks of treatment, the number of vasomotor symptoms was reduced to 1.6 in the elinzanetant group and 3.4 in the placebo group, with the reductions in symptoms maintained throughout the 52-week study. Patients on Bayer’s drug self-reported improvements in sleep as well. Based on positive results from this trial and two other late-stage studies called OASIS 1 and 2 , Bayer submitted an NDA to the FDA for elinzanetant in August, and it plans to file applications to other regulatory agencies. The company told investors this summer that it’s aiming to launch the drug in 2025. Bayer first released topline data for OASIS 3 in March. The most common treatment-emergent adverse events in the elinzanetant arm were headaches and Covid-19, and Bayer noted there were no signs of liver toxicity or incidences of endometrial hyperplasia or endometrial malignant neoplasms. James Simon, study author and clinical professor of obstetrics and gynecology at George Washington University in Washington, DC, told Endpoints News that longer-term studies like OASIS 3 are “really, really important,” especially for this drug class. Elinzanetant is a dual neurokinin-1 and -3 receptor antagonist, which Bayer says is the first drug of its kind in late-stage development for the treatment of menopausal vasomotor symptoms associated with menopause. It’s given orally once a day. “In this particular case, safety has been brought more to the forefront, because drugs in this class, the neurokinin modulators, some of them have failed and been very problematic for safety, and have never really come to become clinically tested,” Simon said. “Others already on the market have some minor or mild safety signals, which have elevated the FDA to make changes in and restrictions in their labeling that are safety-related.” JoAnn Pinkerton, the study’s author and division director of Midlife Health Center at UVA Health in Charlottesville, VA, said that Bayer’s drug could be a new treatment option for menopausal women with these symptoms who can’t or don’t want to take hormone therapies. She also noted that another ongoing Phase 3 trial called OASIS 4 is investigating the drug in women who either are at high risk for breast cancer or who have had breast cancer. These patients are also on a therapy and endocrine therapy either to prevent or treat breast cancer. “When you look at the populations of women who can’t take hormone therapy or choose not to, it’s women that are at risk for breast cancer, or have had breast cancer, stroke or blood clots, migraines. Those are women that need help, and we haven’t had effective treatment to date,” Pinkerton said.

This week, Bayer announced results from its phase 3 OASIS 3 trial, confirming the efficacy and long-term safety of elinzanetant for treating vasomotor symptoms (VMS) associated with menopause. The trial showed that elinzanetant significantly reduced the frequency of moderate to severe hot flashes over 12 weeks compared to placebo, with sustained improvements in sleep disturbances and quality of life observed over 52 weeks. These results build on earlier positive findings from the OASIS 1 and 2 studies. The OASIS 3 study involved 628 postmenopausal women and confirmed that elinzanetant met its primary and secondary endpoints, showing a reduction in VMS symptoms without the safety concerns typically associated with hormone treatments. The safety profile was consistent with prior studies, with no signs of liver toxicity or endometrial malignancies. Elinzanetant is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development for non-hormonal treatment of VMS. The compound offers a new, once-daily oral option for managing menopause-related symptoms without the risks tied to hormone replacement therapy. Based on the successful outcomes of OASIS 1, 2, and 3, Bayer has submitted a new drug application to the U.S. FDA for elinzanetant, with additional marketing authorization applications submitted to health authorities worldwide. If approved, elinzanetant will join Astellas' Veozah in the menopause symptoms space. Astellas won approval for the once-daily pill, a neurokinin 3 (NK3) receptor antagonist, a year ago . Veozah was the first non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.