Bayer's Potential First-in-Class Therapy Elinzanetant Meets Primary Endpoints in Two Phase 3 Trials for Menopausal Vasomotor Symptoms

▎Edited by the WuXi AppTec content team

Bayer today announced positive topline results from the two pivotal Phase 3 clinical trials, OASIS 1 and OASIS 2, for the investigational therapy elinzanetant.

In postmenopausal women, elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) compared to placebo.

Moreover, both studies achieved all key secondary endpoints. This includes a significant reduction in VMS frequency from baseline to Week 1, as well as significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety profile of elinzanetant observed in the OASIS 1 and 2 studies is consistent with previously published data, reflecting its consistency and reliability.

Elinzanetant is a potential "first-in-class" dual neurokinin-1,3 (NK-1,3) receptor antagonist administered orally once daily. It addresses VMS issues by modulating estrogen-sensitive neurons (KNDy neurons) in the hypothalamus.The decline in estrogen levels may lead to the hypertrophy of these neurons, triggering the overactivation of thermoregulatory pathways, which can result in VMS. In 2020, Bayer acquired KaNDy Therapeutics for approximately $875 million (including a $425 million upfront payment and $450 million in milestone payments), gaining access to this potential "first-in-class" therapy.

▲Elinzanetant Molecular Structure (Image Source: PubChem)

OASIS 1 and 2 studies are the first two Phase 3 clinical trials in the broader OASIS clinical development program, with detailed results planned for presentation at an upcoming scientific conference. Results from the third Phase 3 clinical study, OASIS 3, are expected to be announced in the near future.Bayer plans to submit the data from the OASIS 1, 2, and 3 studies to regulatory authorities for approval to treat moderate to severe VMS associated with menopause.

By 2030, the number of women worldwide experiencing menopause is expected to increase to 1.2 billion, with 47 million entering this phase each year. Menopause is a transitional stage in a woman’s life associated with the gradual decline of ovarian function, typically occurring in women in their 40s or early 50s. The decrease in hormones can lead to various symptoms, including vasomotor symptoms (VMS), sleep disturbances, and mood changes, all of which can significantly impact women's health, quality of life, and work productivity. Effectively addressing these symptoms is crucial for maintaining normal function and quality of life during menopause.

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