Bayer heats up hot flash rivalry, hitting phase 3 goals to stay on Astellas’ heels

Bayer has kept up the pressure on Astellas’ hot flash drug Veozah, reporting a clean sweep of coprimary endpoints in a pair of phase 3 trials of its rival molecule elinzanetant.

Astellas and Bayer bought spots at the head of the race for the postmenopausal market, respectively paying 500 million euros ($547 million) for Ogeda and $425 million upfront for KaNDy Therapeutics. The deals covered molecules designed to bring relief for hot flashes, known medically as moderate to severe vasomotor symptoms (VMS), without using hormones. 

Having seen Astellas win FDA approval for its drug last year, Bayer reported topline data from two pivotal trials of its rival candidate, elinzanetant, Monday. The readout suggests Bayer has a good shot at getting elinzanetant to market without providing much clarity on how the molecule matches up to Veozah.

Like Astellas, Bayer tested its candidate against four coprimary endpoints that looked at the severity and frequency of hot flashes after four and 12 weeks of treatment. And, again like Astellas, the drugmaker met all four coprimary endpoints across the two studies. Both molecules acted on hot flashes in the first week of treatment and were linked to improvements in sleep disturbances and quality of life.

Bayer is yet to share any numbers from the studies. With Astellas’ Veozah already on the market, the details of the data could go a long way to determining whether Bayer can and establish elinzanetant as a major product. Elinzanetant has a slightly different mechanism than Veozah, acting on neurokinin-1 (NK-1) and 3 rather than just neurokinin-3.

Other researchers have linked antagonism of NK-1 to effects on insomnia and mood disorders unrelated to menopause, suggesting that Bayer’s dual-target approach may help improve sleep, but the lack of data in Bayer’s release means the clinical impact of the mechanism remains unclear. 

The German drugmaker plans to share the data at upcoming scientific congresses. Preparations for the presentations will proceed alongside work to wrap up a third phase 3 trial, results from which are due in the coming months, and file for approval in the treatment of moderate to severe VMS associated with menopause.