Bayer Touts Phase III Results for Menopause Symptom Drug

Bayer NJ Headquarters/iStock, JHVEPhoto

Pictured: Bayer's office in New Jersey/iStock, JHVEPhoto

Bayer on Thursday posted data from two late-stage studies of elinzanetant, which aims to treat women who have severe vasomotor symptoms, or hot flashes, associated with menopause in a challenge to Astellas’ approved treatment Veozah.  

Elinzanetant, is a dual neurokinin-1,3 (NK-1,3) receptor antagonist. It met four primary endpoints across two Phase III clinical trials, Oasis-1 and Oasis-2.

In the Oasis-1 trial, the candidate showed mean reductions against a placebo for the frequency of hot flashes, posting -3.29 at week four and -3.22 at week 12. For the severity of hot flashes in the study, Bayer posted a -0.33 reduction at week four and a -0.40 at week 12.

Oasis-2 reduced the frequency of hot flashes by -3.04 at week four and -3.24 at week 12. For the severity of hot flashes, elinzanetant posted a reduction of -0.22 at week four and -0.29 at week 12. Bayer will present the data at the American College of Obstetricians and Gynecologists annual meeting, which will take place May 17 through 19, 2024.

“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’s main competition in the vasomotor symptom space is Astellas. The Japanese pharma won FDA approval for its neurokinin 3 receptor antagonist Veozah in May 2023, which brought in 7.3 billion yen ($46.8 million) in fiscal year 2023. However, Veozah’s label does include warnings about high liver blood test values and side effects such as back pain, stomach pain, insomnia and diarrhea. 

The safety profile for elinzanetant was favorable in both studies, with fatigue and headache being the most common adverse events. Bayer intends to submit data from the Oasis-1, Oasis-2, and Oasis-3 trials to global health authorities for approval of marketing authorities but did not specify which agencies.

In March 2024, Bayer announced positive topline results for the Phase III Oasis-3 trial. In that study, elinzanetant reached the primary endpoint of the mean change in the frequency of moderate to severe hot flashes after 12 weeks of a daily dose versus placebo.  

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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