Bayer has announced positive topline results from the Phase III OASIS 3 study, shedding light on the potential efficacy and safety of their investigational compound, elinzanetant, in treating moderate to severe vasomotor symptoms (VMS) linked to menopause. These findings bolster the case for elinzanetant’s marketing authorization submissions, which Bayer plans to present to health authorities.

In the OASIS 3 study, elinzanetant demonstrated a statistically significant reduction in the frequency of moderate to severe VMS over a 12-week period compared to a placebo. Furthermore, the long-term safety profile observed over 52 weeks aligns with previous studies, suggesting a favorable safety profile for elinzanetant.

“OASIS 3 was designed to address the important question of the long-term profile of elinzanetant. With the positive topline results of OASIS 3 adding to the existing evidence from OASIS 1 and 2, elinzanetant has consistently shown positive data across all Phase III clinical trials in the treatment of moderate to severe VMS associated with menopause,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We are looking forward to sharing the full data at upcoming medical conferences as we move towards submitting to health authorities.”

Elinzanetant is the 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.

“It is critical that we continue to broaden therapeutic options that will effectively meet the significant needs of menopausal women,” said Nick Panay, Principal Investigator for OASIS 3, Consultant Gynaecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and President of International Menopause Society. “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms.”

The OASIS clinical development program, which includes studies like OASIS 1, 2, and 3, aims to evaluate the efficacy and safety of elinzanetant in women with moderate to severe VMS associated with menopause. These studies build upon positive data from earlier phases, indicating the potential of elinzanetant as a promising treatment option for menopausal symptoms.

Vasomotor symptoms, including hot flashes, affect a significant portion of menopausal women and can have a profound impact on their quality of life. Elinzanetant’s unique mechanism of action offers hope for women experiencing these symptoms, providing a potential avenue for improved symptom management and overall well-being during the menopausal transition.

As Bayer continues to advance elinzanetant through clinical development, the prospect of offering women a non-hormonal solution for menopausal symptoms grows closer. With ongoing research and submissions for marketing authorization underway, elinzanetant represents a promising addition to the arsenal of treatments available to support women’s health during the menopausal transition.

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