Bayer’s non-hormonal drug elinzanetant, designed to treat hot flashes experienced by women during the menopause, has now achieved good Phase III results in three clinical trials.
The German pharma company submitted a New Drug Application to the FDA earlier this month based on these results and plans to submit additional applications to additional health regulators in different regions soon.
Originally developed at U.K.-based biotech KaNDy Therapeutics, Bayer acquired the company and its lead asset NT-814 (now known as elinzanetant) in 2020 to add to its women’s healthcare pipeline. The drug works by regulating estrogen sensitive nerve cells in the hypothalamus region of the brain that control temperature regulation, but become dysfunctional during the menopause due to lower levels of estrogen in the body.
The results of two of the trials, Oasis 1 and 2, were published this week in JAMA, although announced publicly earlier this year, and confirmed that the oral, selective neurokinin-1,3 receptor antagonist had met all primary and secondary endpoints in women with moderate to severe hot flashes associated with menopause over 26 weeks.
Additional supporting data from the longer-term Oasis 3 study show that efficacy and safety findings in a similar group of women, aged 40–65 years across all three trials, were maintained at 52 weeks.
“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms (also known as hot flashes) and sleep disturbances, reported by up to 80% and 60%, respectively,” explain lead author JoAnn Pinkerton, MD, a clinician and researcher at University of Virginia Health, and colleagues.
“Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.”
Current treatment options for hot flashes are limited and mostly consist of hormonal replacement therapy, which can be risky for some women. New treatment options for menopausal women are therefore needed.
Oasis 1 took place in the US, Europe, and Israel between 2021 and 2023 and Oasis 2 in the U.S., Canada, and Europe over a similar time period.
Vasomotor symptoms were reduced by elinzanetant by 65.2% and 67.0% in Oasis 1 and 2, respectively, compared with reductions of 42.2% and 45.9% in the respective placebo groups. At 26 weeks, 80% of those taking elinzanetant had achieved at least a 50% reduction in symptoms.
Secondary endpoints included a significant reduction in frequency of hot flashes, and improvements in sleep and other menopause-related quality of life issues, all of which were also met.
The safety profile of elinzanetant appears to be good, with no observed liver toxicity, and the most commonly reported side effects in the trials were headache and fatigue.
“Women experiencing menopause need treatment options that can help reduce the impact of symptoms on their quality of life,” said co-author James A. Simon, clinical professor of obstetrics and gynecology at George Washington University, in a press statement.
“The results from OASIS 1 and 2 are very promising when looking to address the unmet needs many women may experience during the menopause transition.”
