Astellas Pharma has reported positive topline results from the Phase IIIb DAYLIGHT clinical trial of fezolinetant for the treatment of vasomotor symptoms (VMS) due to menopause.
The placebo-controlled, randomised, double-blind study is designed to evaluate the safety and efficacy of the investigational, oral, non-hormonal compound fezolinetant in menopausal women with moderate to severe VMS.
It enrolled 453 women aged 40-65 years from 69 sites in Turkey, Europe, and Canada.
Menopausal women who are considered unsuitable for hormone therapy received 45mg fezolinetant once daily for 24 weeks or a placebo.
At week 24, the study met the primary objective, demonstrating a statistically significant reduction from baseline in the frequency of moderate to severe VMS.
Less than 5% of patients showed common adverse treatment-emergent events of headaches and Covid-19.
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Additional safety and efficacy data from the DAYLIGHT study will be used to support reimbursement dossiers throughout Europe and health technology assessments.
Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is available as VEOZAH in the US.
Astellas biopharma development head and vice-president Marci English said: “These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot, or choose not to, take hormone therapy.”
Last year, Astellas Pharma reported topline findings from the Phase III MOONLIGHT 3 clinical trial of fezolinetant to treat moderate to severe VMS linked to menopause in women in mainland China.