Bayer’s non-hormonal therapy elinzanetant met primary and secondary endpoints in two pivotal Phase III trials by reducing the frequency and severity of moderate to severe vasomotor symptoms, commonly known as hot flashes, in post-menopausal women.

Elinzanetant met all four primary endpoints in the Phase III OASIS 1 and 2 trials (NCT05042362 and NCT05099159) by showing statistically significant reductions in the frequency and severity of moderate to severe hot flashes at four and 12 weeks from baseline, compared to placebo. The trials enrolled 396 and 400 postmenopausal women between 40 and 65 years who either received elinzanetant or placebo.

In the OASIS 1 trial, the participants in the therapy group observed a mean reduction of -3.29 and -3.22 in the frequency of hot flashes at four and 12 weeks respectively, compared to placebo. The elinzanetant group also saw a -0.33 and -0.40 mean reduction in the severity of hot flashes at four and 12 weeks respectively, compared to the placebo.

In the OASIS 2 trial, the mean reduction in the frequency of hot flashes with elinzanetant treatment compared to placebo at four and 12 weeks was -3.04 and -3.24 respectively. The treatment group demonstrated a reduction in the severity of -0.22 and -0.29 at four and 12 weeks respectively, compared to the placebo group.

The trials also met three secondary endpoints by showing improvements in sleep disturbances and menopause-related quality of life, compared to placebo, and by reducing the frequency of hot flashes after 1 week, compared to baseline. The commonly observed treatment-related side effects in both trials included headache and fatigue.

In March, Bayer announced that another study, the Phase III OASIS 3 trial (NCT05030584), evaluating elinzanetant met the primary endpoints. The therapy showed a reduction in the frequency of hot flashes from baseline to 12 weeks, compared to placebo. The company plans to file for regulatory approval for elinzanetant based on the positive data from the three OASIS trials.

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Elinzanetant is an inhibitor of both neurokinin-1 and 3 (NK-1 and 3) receptors. These receptors are found mainly in the central nervous system and the spinal cord and play a part in the regulation of the hypothalamus-pituitary-adrenal (HPA) axis, which is responsible for hormone regulation. The therapy was added to Bayer’s portfolio as part of the acquisition of UK-based KaNDy Therapeutics in 2020.

Elinzanetant’s main competitor is Astellas’ Veozah (fezolinetant), a NK-3 receptor agonist. The US Food and Drug Administration (FDA) approved Veozah as a treatment for hot flashes in May last year. The therapy generated Y7.3bn ($46.8m) in sales last year, as per the Astellas 2023 financials.

According to GlobalData analysis, both drugs are expected to have billion-dollar sales in the next decade, with Astellas’ therapy having a first-to-market advantage. Veozah and elinzanetant are forecasted to respectively earn $1.8bn and $1bn in sales in 2030.

GlobalData is the parent company of Clinical Trials Arena.

Bayer plans to distinguish its post-menopausal non-hormonal therapy by possibly expanding its indication. The company is evaluating elinzanetant as a treatment for sleep disturbance associated with menopause in a Phase II NIRVANA trial (NCT06112756). The placebo-controlled study is expected to enrol 78 post-menopausal participants with ongoing sleep disturbances, such as waking up at night and/or poor quality of sleep.