Bayer has shared positive topline results from two late-stage studies evaluating its investigational non-hormonal menopause drug elinzanetant as a treatment option for moderate-to-severe vasomotor symptoms (VMS).
VMS, such as hot flashes, are reported by up to 80% of women at some point during the menopausal transition. Over one-third of menopausal women report severe symptoms, which can last for ten years or more after the last menstrual period.
The phase 3 OASIS 1 and 2 studies have been assessing the efficacy and safety of elinzanetant, a dual neurokinin-1,3 receptor antagonist, administered orally once daily in women with moderate-to-severe VMS associated with menopause.
All primary endpoints of the studies were met, with elinzanetant demonstrating statistically significant reductions in the frequency and severity of VMS from baseline to weeks four and 12 compared to placebo.
Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in frequency of VMS from baseline to week one, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
Dr Christian Rommel, member of the executive committee of Bayer AG’s pharmaceutical division and global head of research and development, said the company was “excited” about the positive results from the studies, “reinforcing [elinzanetant’s] potential as a non-hormonal treatment option in menopause management”.
The safety profile observed in both studies was overall consistent with previously published data on elinzanetant, Bayer said.
JoAnn Pinkerton, professor and director of midlife health at UVA Health, said: “Menopausal symptoms such as hot flushes and sleep disturbances can be highly disruptive and broadly impact health and quality of life. Still many women cope in silence and remain untreated.
“It’s important that we continue to research for solutions that address the unmet needs of women, and I am looking forward to the unveiling of the full results.”
The positive readout comes just one month after Astellas Pharma’s non-hormonal neurokinin 3 receptor antagonist fezolinetant was approved by the European Commission under the brand name Veoza to treat moderate-to-severe VMS associated with menopause.
The EU regulator’s decision on the drug, which is also approved in the US as Veozah for the same indication, was supported by positive results from the BRIGHT SKY programme, in which fezolinetant was associated with a significant reduction in the frequency and severity of VMS compared to placebo.