Elinzanetant greatly reduces moderate to severe menopausal hot flashes

Bayer has revealed promising results from its pivotal Phase III studies, OASIS 1 and OASIS 2, involving the investigational compound elinzanetant. These studies highlight a significant reduction in both frequency and severity of vasomotor symptoms (VMS), commonly known as hot flashes, among menopausal women when compared to a placebo. Additionally, the research demonstrated consistent benefits across key secondary endpoints, including improvements in sleep disturbances and menopause-related quality of life. These findings are set to be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting in San Francisco.

Elinzanetant met all four primary endpoints in both studies, showing a statistically significant decrease in moderate to severe VMS from baseline to weeks 4 and 12. Specifically, in OASIS 1, elinzanetant achieved a mean reduction in frequency at week 4 by -3.29 and at week 12 by -3.22, while severity was reduced by -0.33 at week 4 and -0.40 at week 12. Similarly, in OASIS 2, the frequency of VMS decreased by -3.04 at week 4 and -3.24 at week 12, with severity reductions of -0.22 at week 4 and -0.29 at week 12. The compound's safety profile was favorable, with headache and fatigue being the most common treatment-emergent adverse events.

Dr. JoAnn Pinkerton, a professor and director of Midlife Health at UVA Health, emphasized the importance of non-hormonal treatments for menopausal symptoms, noting that many women endure these symptoms untreated for extended periods. She expressed optimism about elinzanetant as a potential non-hormonal solution for women experiencing moderate to severe hot flashes.

Dr. Christian Rommel, a member of Bayer AG's Pharmaceutical Division Executive Committee, highlighted the robust efficacy and favorable safety profile of elinzanetant, reinforcing its potential as a non-hormonal treatment for menopausal VMS. Bayer intends to submit applications for marketing authorizations of elinzanetant to health authorities, aiming to address the unmet medical needs of women experiencing menopause.

Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in its late-stage clinical development for treating moderate to severe VMS. Administered orally once daily, it targets estrogen-sensitive neurons in the hypothalamus, which become hyperactive due to decreased estrogen levels, thereby causing VMS. It also has the potential to alleviate sleep disturbances associated with menopause.

The OASIS studies, which are double-blind, randomized, placebo-controlled multicenter trials, investigate the efficacy and safety of elinzanetant over 26 weeks (OASIS 1 and 2) and 52 weeks (OASIS 3). The studies included postmenopausal women aged 40 to 65 years, with participants receiving either a 120 mg dose of elinzanetant or a placebo. Earlier in March 2024, Bayer announced positive topline results from the OASIS 3 study, reinforcing the compound's long-term safety and efficacy over 52 weeks.

The elinzanetant clinical development program, known as OASIS, consists of four Phase III studies. These studies are designed based on positive data from two Phase II trials, RELENT-1 and SWITCH-1, which investigated the safety, pharmacokinetics, and preliminary efficacy of elinzanetant.

In addition to the OASIS program, Bayer initiated the NIRVANA study, an exploratory Phase II trial focusing on elinzanetant's efficacy in treating sleep disturbances associated with menopause. This trial employs polysomnography, a validated method for studying sleep and underlying causes of disturbances.

Vasomotor symptoms, or hot flashes, affect up to 80% of women during menopause, significantly impacting quality of life. There are currently no approved treatment options for VMS caused by endocrine therapy for breast cancer. By 2030, the global population of menopausal women is expected to rise to 1.2 billion, highlighting the urgent need for effective treatments like elinzanetant.