Bayer shared more data on its menopause symptom drug elinzanetant, which demonstrates how the treatment triumphed over placebo in two of three Phase 3 trials.
In the placebo-controlled OASIS 1 trial, the non-hormonal therapy reduced the frequency of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, at weeks 4 and 12, earning p-values of p<0.0001 and p<0.0001, respectively. It also eased the severity of the hot flashes over the same time periods.
Then, in the OASIS 2 study, elinzanetant had similar success, showing “significant mean reductions” versus placebo in the frequency of hot flashes at week 4 (p<0.0001) and at week 12 (p<0.0001). Again elinzanetant reduced the severity of the symptom at week 4 and at week 12.
The most common treatment-emergent adverse events were headache and fatigue, the company said in a Thursday release.
Bayer announced the positive topline results in March, but did not detail the data until Thursday. It then said it plans to file the drug for regulatory approvals. Elinzanetant also reported positive data in March in the Phase 3 OASIS 3 trial, with the drug again meeting the primary endpoint of the study by achieving a significant reduction in the frequency of moderate to severe VMS at 12 weeks.
Stefan OelrichThe company scored the drug in its buyout of KaNDy Therapeutics in 2020, predicting then that the compound could generate peak annual sales of more than €1 billion globally. According to an AlphaSense transcript, Bayer’s head of pharmaceuticals Stefan Oelrich said late last year during a trial update call that the therapy “is expected to be a blockbuster in its own right.”
As for secondary endpoints in both OASIS 1 and 2, Bayer’s drug showed “statistically significant” reductions in sleep disturbances (p<0.0001) and in overall menopause-related quality of life (p=0.0059). Bayer also reported a statistically significant reduction in the frequency of VMS from baseline to week 1.
“There are limited approved non-hormonal treatments for bothersome menopausal symptoms, such as hot flashes and sleep disturbances,” JoAnn Pinkerton, professor and director of Midlife Health at UVA Health, said in a statement. “These results are exciting news for women who suffer from moderate to severe hot flashes and build on our confidence that elinzanetant may be a potential non-hormonal solution for them.”
Bayer is also starting a Phase II study to test elinzanetant in women with sleep disturbances associated with menopause.