Bayer Initiates Phase III OASIS Program for Elinzanetant, a First-in-Class Non-Hormonal Oral NK1/3 Receptor Antagonist for Menopausal Vasomotor Symptoms

Bayer recently announced the initiation of the Phase 3 clinical development program OASIS, aimed at evaluating the efficacy and safety of elinzanetant for the treatment of menopausal vasomotor symptoms (hot flashes). Elinzanetant is a first-in-class, non-hormonal, once-daily, oral neurokinin-1 and 3 receptor (NK1R/NK3R) antagonist. In September 2020, Bayer completed the acquisition of the UK-based clinical-stage biotechnology company KaNDy Therapeutics Ltd, fully integrating elinzanetant into its women's healthcare development pipeline.

Vasomotor symptoms (hot flashes) are reported by up to 80% of women at some point during the menopausal transition and constitute the primary reason for seeking medical care during this specific stage of a woman's life. More than one-third of women report severe symptoms, which may persist for 10 years or longer after the final menstrual period. Vasomotor symptoms can adversely affect sleep, mood, and quality of life.

The OASIS Phase 3 clinical development program will investigate the efficacy and safety of 120 mg elinzanetant administered once daily in menopausal women with vasomotor symptoms. The program plans to enroll approximately 1,300 patients across more than 200 centers in over 20 countries. The design and dosing of this Phase 3 clinical development program are based on positive data from two Phase 2 studies (RELENT-1 and SWITCH-1), which confirmed the favorable efficacy and safety profile of elinzanetant. RELENT-1 was a Phase 1b/2a study investigating the safety, pharmacokinetics, and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase 2b study evaluating the efficacy and safety of four different doses of elinzanetant versus placebo in patients with vasomotor symptoms. The study results were presented at the North American Menopause Society (NAMS) 2020 Virtual Annual Meeting.

Chemical structure of elinzanetant (Image source: medkoo.com)

Elinzanetant is a first-in-class, non-hormonal, oral dual neurokinin-1 and 3 receptor (NK1R, NK3R) antagonist currently in clinical development for the treatment of menopausal vasomotor symptoms. Elinzanetant addresses vasomotor symptoms by modulating a group of estrogen-sensitive neurons (KNDy neurons) in the hypothalamus, which become hyperactive in menopausal women due to estrogen deficiency, thereby disrupting thermoregulatory mechanisms and exacerbating vasomotor symptoms such as hot flashes.

By 2030, the global population of menopausal and postmenopausal women is projected to reach 1.2 billion, with an annual increase of 47 million. Menopause is an inevitable process, as ovarian aging typically occurs in women in their 40s or 50s. The decline in ovarian hormone secretion leads to various symptoms that can significantly impact women's health, quality of life, healthcare expenditures, and work productivity.

Note: The original text has been abridged.

Original Source: Bayer starts Phase III clinical development program OASIS with Elinzanetant

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