Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies

Posted on January 18, 2024

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Source: businesswire

• OASIS 1 and 2 pivotal studies evaluating investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) compared to placebo in postmenopausal women
• Both studies also showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week 1, as well as improvement of sleep disturbances and menopause-related quality of life
• The safety profile observed in both studies is overall consistent with previously published data on elinzanetant
• OASIS 1 and 2 are two of three Phase III clinical studies investigating the efficacy and safety of elinzanetant, a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, as a non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily

Bayer today announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo.

Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data1,2 on elinzanetant.

“We are excited about the positive results of these two pivotal Phase III studies for elinzanetant, reinforcing its potential as a non-hormonal treatment option in menopause management,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "We want to thank the women participating in the OASIS studies, their families, and all study investigators as well as their clinical and nursing staff for their time and commitment to advance menopause research."

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

“Menopausal symptoms such as hot flashes and sleep disturbances can be highly disruptive and broadly impact health and quality of life, still many women cope in silence and remain untreated,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health. “It’s important that we continue to research for solutions that address the unmet needs of women, and I am looking forward to the unveiling of the full results.”

OASIS 1 and 2 (NCT05042362 and NCT05099159) are the first two Phase III studies in the OASIS clinical development program with results, and the details are planned to be presented at upcoming scientific congresses. The results of the third Phase III study OASIS 3 (NCT05030584) are expected in the coming months. Bayer plans to submit data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations for treatment of moderate to severe VMS associated with menopause.

About the OASIS 1 and 2 studies

OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries.

About the OASIS Clinical Development Program

The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.

About Elinzanetant

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.