Elinzanetant Achieves Success in OASIS Phase III Trials for Postmenopausal VMS

Bayer has reported successful outcomes from the OASIS 1 and 2 studies, which evaluated the investigational drug elinzanetant for treating vasomotor symptoms (VMS) in postmenopausal women. The trials demonstrated a significant reduction in both the frequency and severity of VMS, commonly referred to as hot flashes, when compared to placebo treatments. Notably, elinzanetant, a novel dual neurokinin-1,3 (NK-1,3) receptor antagonist, showed its effectiveness from the first week of treatment and continued through weeks 4 and 12.

In addition to the primary endpoints, the studies also met all secondary goals, highlighting improvements in sleep disturbances and the overall quality of life related to menopause. The safety profile of elinzanetant was found to be in line with earlier research, which is reassuring for its potential use as a non-hormonal daily oral treatment for VMS.

Dr. Christian Rommel, a key figure at Bayer AG’s Pharmaceutical Division, expressed enthusiasm about the results, emphasizing the importance of non-hormonal options in managing menopause. JoAnn Pinkerton, an expert in midlife health, underscored the need for treatments that address the often-overlooked challenges faced by women during menopause.

The OASIS trials are part of a larger clinical development program for elinzanetant, which includes four Phase III studies. The first two have shown promising results, and the data from these, along with the forthcoming results from OASIS 3, will be submitted to health authorities for consideration for marketing authorizations.

VMS affect a significant portion of women during menopause, with over 80% experiencing these symptoms at some point. These symptoms can be long-lasting and severely impact a woman's daily life and well-being. The development of elinzanetant, which targets the hypothalamic neurons sensitive to estrogen changes, offers hope for a new approach to managing these symptoms.

Bayer's commitment to women's health is evident through its broad portfolio of treatments and its dedication to innovation in this field. The company aims to provide access to family planning and contraceptives to 100 million women annually in low-and-middle-income countries by 2030, aligning with the United Nations' Sustainable Development Goals.

The positive results from the OASIS studies are a step forward in offering new treatment options for women suffering from VMS, potentially leading to improved health outcomes and quality of life during menopause.