Elinzanetant Meets Endpoints in 52-Week Menopause Hot Flash Trial

Bayer has achieved a significant milestone in its Phase III clinical trials for elinzanetant, a potential treatment for menopausal hot flashes. The drug, a dual neurokinin-1 and neurokinin-3 receptor antagonist, has shown positive results in improving symptoms over a 52-week period. The trial's primary endpoint focused on the average change in the frequency of moderate to severe hot flashes after 12 weeks of daily oral dosing with elinzanetant compared to a placebo. The drug's safety profile over 52 weeks was found to be in line with previous studies, including a Phase 2b dose-finding trial.

Bayer is poised to submit data from all three of its clinical trials for regulatory approval. If approved, elinzanetant will compete with Veozah, an NK3 receptor antagonist developed by Astellas, which was FDA-approved in May 2023 for treating vasomotor symptoms associated with menopause. Astellas has reported substantial sales for Veozah and has invested in high-profile advertising campaigns.

While Bayer has yet to release detailed comparative data between elinzanetant and Veozah, it has hinted at a potential advantage due to its dual receptor targeting. This could potentially lead to benefits in sleep improvement, a common issue for menopausal women experiencing hot flashes. Bayer's extended trial also examined sleep disturbances but has not yet disclosed the findings.

The success of elinzanetant is crucial for Bayer, which has a limited late-stage pipeline and is facing upcoming patent expirations for key products. The company halted a Phase III trial for asundexian in late 2023 and is now pinning its hopes on elinzanetant, as well as other late-phase treatments for prostate cancer and chronic kidney disease, to bolster its growth and mitigate the impact of patent losses for Xarelto.

The outcome of Bayer's efforts with elinzanetant will be pivotal in shaping the company's future in the pharmaceutical market, especially as it seeks to diversify its product offerings and address upcoming challenges.