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.
James SimonAfter 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 PinkertonJoAnn 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.