Bayer has shared positive long-term results supporting the use of its investigational non-hormonal menopause drug elinzanetant as a treatment 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 and over one-third of menopausal women report severe symptoms.
The late-stage OASIS 3 study has been assessing the efficacy and long-term safety profile of Bayer’s dual neurokinin-1,3 receptor antagonist, taken orally once daily, versus placebo over 52 weeks.
The trial met its primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo.
Additionally, the long-term safety profile observed over 52 weeks was overall consistent with previously conducted studies and published data on elinzanetant.
The readout from OASIS 3 comes shortly after Bayer shared positive topline results from the phase 3 OASIS 1 and 2 studies of elinzanetant.
The company outlined in its January announcement that all primary endpoints of the studies were met, with elinzanetant associated with 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’s pharmaceutical division and global head of research and development, said: “OASIS 3 was designed to address the important question of the long-term efficacy and safety profile of elinzanetant.
“With the positive topline results of OASIS 3 adding to the existing evidence from OASIS 1 and 2, elinzanetant has consistently shown positive data across all phase 3 clinical trials in the treatment of moderate-to-severe VMS associated with menopause in women.”
The results of OASIS 1, 2 and 3 will be presented at upcoming scientific congresses, Bayer said, adding that it will be submitting data from all three studies to health authorities for approval of elinzanetant.