Bayer AG: Elinzanetant Shows Promise In Treating Menopause-Associated Vasomotor Symptoms In Phase 3 Clinical Trials
- Elinzanetant reduced the frequency and severity of menopause-associated vasomotor symptoms in two phase 3 clinical trials.
- Elinzanetant was safe and well tolerated, with the only treatment-requiring adverse effects being headaches and fatigue.
The Latest
In the double-blinded, randomized, placebo-controlled phase 3 OASIS 1 and 2 clinical trials funded by Bayer AG, researchers assessed the safety and efficacy of elinzanetant in the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) in postmenopausal women. Three hundred ninety-six and 400 women in OASIS 1 and 2, respectively, were randomized between a placebo and treatment group. The treatment arm received a 120 mg dose of elinzanetant for 26 weeks. Study participants were assessed at weeks 4 and 12 for frequency and severity of VMS. Frequency and severity were assessed using a hot flash daily diary. OASIS 1 and 2 demonstrated statistically significant mean reductions in both frequency and severity of VMS at week 4 and week 12. Additionally, both trials also met their secondary endpoints by showing statistically significant improvements in quality of sleep and quality of life versus placebo groups. Elinzanetant was well tolerated by participants. The most common adverse events requiring treatment were headaches and fatigue. Bayer AG has now completed an OASIS 3 trial assessing the safety and efficacy of elinzanetant over a 52-week study period. Bayer has announced favorable results from the study and will make the data formally available at a yet-to-be-announced future event.
Physician’s Perspective
Menopause is defined as the date of the final menstrual period determined after 12 months of amenorrhea. Menopause typically occurs in individuals aged 45-56 years old and can have many symptoms. One of these symptoms is known as VMS. During menopause reduced ovarian function leads to a decrease in estrogen levels. This results in the hypertrophy of a special group of neurons in the hypothalamus called the Kisspeptin, neurokinin B, and dynorphin neurons (KNDy neurons). KNDy neurons are responsible for cutaneous vasodilation which results in VMS. VMS is characterized primarily by hot flashes, but also heat intolerance and increased sweating. Symptoms typically last for 7 years but may sometimes exceed 10 years. Presently, VMS is treated both non-pharmacologically and pharmacologically. Nonpharmacologic interventions include lifestyle modifications: avoidance of alcohol, caffeine, spicy foods, and decreasing stress. The first line of pharmacologic treatment for VMS is hormone replacement therapy (HRT). The adverse effects of HRT can range from the more common mood swings and GI upset to more severe effects like the development of estrogen-sensitive cancers and strokes. A non-hormonal intervention like Bayer’s elinzanetant may prove to be the preferred alternative to HRT in the future.
Molecular Target of Therapy
Elinzanetant is a neurokinin/tachykinin-1,3 (NK-1,3) receptor antagonist. It is a non-hormonal compound that is administered orally. Elinzanetant is thought to interfere with the thermoregulatory pathway mediated by KNDy neurons by preventing the binding of substance P and neurokinin B to NK receptors. This is thought to lead to a reduction in cutaneous vasodilation which reduces the frequency and severity of VMS.
Company History
Elinzanetant was developed by Bayer AG, a pharmaceutical and biotechnology company. Bayer has made contributions to the fields of cardiology, oncology, and many more. Bayer is also involved in cutting-edge research and development of gene and cell therapies for the treatment of inheritable and medically intractable diseases like Pompe disease, Parkinson’s disease, and Huntington’s disease. Very recently, Bayer announced they would present real-world data on the efficacy of Kerendia (finerenone) in the treatment of chronic kidney disease in 28000 patients with type 2 diabetes at the 61st European Renal Association (ERA) congress.
Further reading: https://www.bayer.com/en/us/news-stories/elinzanetant
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