Phase III clinical success of Astellas NK3R antagonist fezolinetant in the treatment of menopausal VMS

Compilenewborn

Astellas recently announced the 12-week results of the pivotal Phase 3 SKYLIGHT 2 clinical trial

Fezolinetant is a non-hormonal, selective neurokinin-3 receptor (NK3R) antagonist that blocks specific receptors in the temperature control center (hypothalamus) of the brain to reduce the frequency and severity of VMS associated with menopause

The results from the SKYLIGHT 2 study showed that the 30mg and 45mg doses of fezolinetant orally once a day reached the common primary endpoint of the study: compared with placebo, the incidence and severity of moderate to severe VMS in weeks 4 and 12 were statistically significant Significantly reduced

For the common primary endpoint of the reduction in the average frequency of moderate to severe VMS: (1) Compared with placebo, the 30 mg dose of fezolinetant had an average daily change of -1.

For the common primary endpoint of the reduction in the average severity of moderate to severe VMS: (1) Compared with placebo, the average daily change of 30 mg dose of fezolinetant in the 4th week and the 12th week was -0.

In this study, 40%, 36%, and 32% of patients in the 30mg, 45mg, and placebo groups reported treatment-period adverse events (TEAE)

VMS is the most common symptom that menopausal women seek treatment, but women and healthcare providers have limited non-hormonal options

If the Phase 3 project is successful and approved for marketing, fezolinetant is expected to bring a first-in-class non-hormonal treatment program in the treatment of menopausal-related moderate to severe VMS

Reference source: Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ Trial in Oral Session at The North American Menopause Society 2021 Annual Meeting