Bayer to Reveal Phase III OASIS 3 Study Data on Elinzanetant for Menopausal Vasomotor Symptoms

Bayer has announced it will unveil detailed findings from the Phase III OASIS 3 study at The Menopause Society's annual meeting, scheduled from September 10-14 in Chicago. This study assesses the efficacy and long-term safety of elinzanetant, a non-hormonal treatment for vasomotor symptoms (VMS) related to menopause, compared to a placebo. Attendees will also hear presentations on pooled efficacy results from earlier Phase III studies, OASIS 1 and 2, marking the first time these findings are shared publicly.

The OASIS program, consisting of studies OASIS 1, 2, and 3, evaluated the effects of elinzanetant on VMS, a common issue affecting postmenopausal women. OASIS 1 and 2 were double-blind, randomized, placebo-controlled multicenter studies involving 796 postmenopausal women across 184 sites in 15 countries. These studies spanned 26 weeks, with participants receiving a daily 120 mg dose of elinzanetant or a placebo. OASIS 3 extended the treatment period to 52 weeks and enrolled 628 women across 83 sites in 9 countries.

Elinzanetant represents a novel approach as it is the first dual neurokinin-1 and 3 receptor antagonist under late-stage clinical development for VMS. The compound targets a cluster of estrogen-sensitive neurons in the hypothalamus, which become overactive as estrogen levels decline, leading to disrupted body heat regulation. By modulating these neurons, elinzanetant aims to ease VMS and may also offer relief from menopause-related sleep disturbances.

The OASIS 4 study expands on the clinical development program by examining elinzanetant's effects on VMS induced by endocrine therapy for breast cancer. This study's design and dosing are based on promising results from two Phase II studies, RELENT-1 and SWITCH-1. RELENT-1 focused on the safety and pharmacokinetics of elinzanetant, while SWITCH-1 compared various doses of the drug to a placebo in women experiencing VMS.

Bayer is also conducting an exploratory Phase II study named NIRVANA, which investigates elinzanetant's efficacy in addressing sleep disturbances linked to menopause. This study utilizes polysomnography, a validated method for examining sleep issues, to gather data on the drug's impact on sleep quality and overall safety.

Beyond these clinical studies, Bayer maintains a robust commitment to women's healthcare. The company aims to provide innovative treatments for conditions such as menopause and gynecological diseases. Bayer also supports global family planning initiatives, aspiring to offer 100 million women in low- and middle-income countries access to modern contraceptives by 2030. This is part of their broader sustainability strategy aligned with the United Nations' Sustainable Development Goals.

Bayer's overarching mission is to foster health and nutrition through its products and services, addressing global challenges posed by an aging and growing population. In 2023, Bayer employed around 100,000 people and reported sales of 47.6 billion euros, with 5.8 billion euros allocated to research and development.

At the Menopause Society meeting, several other presentations will cover topics such as the impact of sleep disturbances on depression and anxiety in menopausal women, and the design of the NIRVANA study. These discussions underscore Bayer's dedication to advancing women's health through rigorous research and innovative treatments.

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