OASIS 3 Study Bolsters Marketing Approval for Bayer's Elinzanetant

The OASIS 3 trial has yielded promising efficacy and safety data for elinzanetant, a novel compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS), commonly referred to as hot flashes, associated with menopause. This latest study builds upon the positive outcomes from the OASIS 1 and 2 trials, reinforcing the potential of elinzanetant as a non-hormonal therapeutic option for menopausal women.

Elinzanetant, a first-of-its-kind dual neurokinin-1,3 receptor antagonist, is currently in the final stages of clinical development. It is administered orally once a day and has demonstrated a statistically significant reduction in the frequency of VMS from baseline to week 12 when compared to a placebo. The safety profile observed over the 52-week study period aligns with previous findings, offering a consistent picture of the drug's long-term effects.

Dr. Christian Rommel, a key member of Bayer AG's Pharmaceutical Division and the Global Head of Research and Development, emphasized the importance of the OASIS 3 study in understanding the long-term effects of elinzanetant. He expressed anticipation for sharing the complete data at future medical conferences and the subsequent submission to health authorities for marketing authorization.

Nick Panay, the Principal Investigator for OASIS 3 and a leading figure in gynecology and menopause research, highlighted the need for broadening treatment options to effectively address the needs of menopausal women. The positive results from the OASIS trials have bolstered confidence in elinzanetant's efficacy and safety as a potential new non-hormonal solution for VMS.

The OASIS clinical development program includes four Phase III studies, with OASIS 3 focusing on the 52-week efficacy and safety of elinzanetant in postmenopausal women. The study involved 628 participants aged between 40 and 65 years across multiple sites in various countries.

Elinzanetant's mechanism of action involves modulation of estrogen-sensitive neurons in the hypothalamus, which are implicated in the thermoregulatory pathway disruption that leads to VMS during menopause. It also shows potential in reducing sleep disturbances associated with this transitional phase.

VMS affect up to 80% of women during menopause and can significantly impact quality of life. With an aging global population and an increasing number of women entering menopause each year, the development of effective treatments is crucial. Bayer, with its long-standing commitment to women's health, is at the forefront of advancing innovative treatments to address these unmet medical needs.

The company's focus on women's healthcare is part of its broader sustainability measures, which include providing access to family planning and contraceptives in low-and-middle income countries by 2030. This aligns with Bayer's mission to support a healthier and more sustainable future for all.

Bayer, a global life sciences company, is dedicated to improving health and nutrition through its products and services. With a commitment to innovation and growth, the company aims to increase its earning power and create value while driving sustainable development and generating a positive impact worldwide.