Bayer’s drug to relieve menopause-related hot flushes succeeds in late-stage trial

Frankfurt — Bayer said its menopausal relief drug eased hot flushes and improved sleep in two late-stage trials, much-needed good news for the German group’s pharmaceuticals unit that is reeling from a recent development setback.

Germany’s Bayer said in a statement on Monday that its elinzanetant drug candidate met the main goal in two phase III trials of reducing the frequency and severity of vasomotor symptoms, also known as hot flushes, in postmenopausal women.

The read-out marks a slight turn of fortune for embattled Bayer, which aborted a large late-stage trial testing a new anti-blood-clotting drug in November due to a lack of efficacy, throwing its most promising development project into doubt.

Prior to the setback, Bayer had estimated that the blood-thinning drug could have peak annual sales of more than €5bn, while elinzanetant was given the potential of about $1bn or more per year.

Among secondary trial goals, the drug was also shown to ease sleep disturbances and improve menopause-related quality of life. Further details of the trials would be presented at as yet undisclosed medical conferences, it added.

New Bayer CEO Bill Anderson is weighing up options to break apart the maker of prescription drugs, consumer health products, crop chemicals and seeds, in a bid to revive a battered share price.

In the race for non-hormonal menopausal symptoms relief drugs, Bayer is behind Japan’s Astellas, which won US and European approval in 2023 for similar treatment Veoza, also known as fezolinetant.

Yet another similar compound, developed by Acer Therapeutics, failed to ease hot flushes in a mid-stage trial in 2023.

Bayer added that the results of a third phase III study testing its elinzanetant were expected in the coming months and that it planned to submit data from all three trials to seek approval from health authorities thereafter.

Reuters