Bayer to Present Phase III OASIS 1 and 2 Data on Elinzanetant for Menopausal Vasomotor Symptoms

Bayer is set to unveil comprehensive results from the pivotal OASIS 1 and 2 Phase III studies at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting in San Francisco from May 17-19. These studies assess the efficacy and safety of the investigational compound elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elinzanetant is administered orally once daily.

In addition to the OASIS 1 and 2 studies, Bayer will present findings from its broader contraception and menopause product portfolio, and host two scientific symposia. These presentations underscore Bayer’s enduring commitment to women’s healthcare, addressing critical unmet medical needs.

In the detailed schedule, the scientific symposium titled "OASIS 1 and 2: Elinzanetant Efficacy and Safety Data From 2 Pivotal Studies," will feature presentations from Dr. James A. Simon and Dr. JoAnn V. Pinkerton on May 17. An e-poster session on May 18 will see Dr. JoAnn V. Pinkerton present findings from OASIS 2, and Dr. James A. Simon present results from OASIS 1, both focusing on the treatment of VMS with elinzanetant.

Additional presentations will include a symposium on understanding the science behind menopause symptoms, led by Dr. JoAnn V. Pinkerton and Dr. Victor Navarro on May 18. Further e-poster presentations will cover topics such as the treatment of endometrial hyperplasia and early-stage endometrial cancer using LNG-IUS, and a real-world data analysis of clinical characteristics of perimenopausal and menopausal women with VMS.

The OASIS studies are extensive double-blind, randomized, placebo-controlled multicenter trials. OASIS 1 and 2 each involved around 400 postmenopausal women aged 40 to 65 across various international sites over 26 weeks. The OASIS 3 study extends the investigation over 52 weeks with 628 participants across multiple countries. Bayer intends to submit the results from these studies to health authorities to seek marketing authorizations for elinzanetant.

Elinzanetant’s clinical development program includes four Phase III studies (OASIS 1, 2, 3, and 4). The first three focus on VMS associated with menopause, while OASIS 4 examines the compound's efficacy and safety in women undergoing endocrine therapy for breast cancer treatment or prevention. The program is built upon positive data from prior Phase II studies, RELENT-1 and SWITCH-1.

Additionally, Bayer has initiated the NIRVANA study, an exploratory Phase II trial to evaluate elinzanetant's efficacy on sleep disturbances associated with menopause using polysomnography, a validated method for studying sleep patterns.

Elinzanetant works by modulating estrogen-sensitive neurons in the hypothalamus (KNDy neurons) that become hyperactive due to declining estrogen levels during menopause, causing VMS or hot flashes. This compound offers a non-hormonal treatment option, addressing a significant need for many women who experience severe symptoms.

Vasomotor symptoms are a common issue during menopause, affecting up to 80% of women at some point, with severe symptoms impacting quality of life for over a third of this population. These symptoms can persist for years, emphasizing the need for effective treatments.

Menopause affects a growing segment of the global population, with projections indicating 1.2 billion women will be experiencing menopause by 2030. This phase involves a decline in ovarian function, leading to symptoms that affect health, quality of life, and productivity. Managing these symptoms is crucial for maintaining wellbeing during menopause.

Bayer’s commitment to women's health is evident through its diverse portfolio of treatments for contraception, menopause, and gynecological conditions. The company aims to enhance women’s healthcare globally, including providing access to family planning resources in low-and-middle-income countries. Bayer’s efforts align with the United Nations’ Sustainable Development Goals, emphasizing its dedication to sustainable development and innovation in women's healthcare.