Both trials met all four co-primary endpoints showing statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS to week 4 and week 12 for women who received fezolinetant 30 and 45 mg once-daily (QD) versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 2 percent of patients and the most common TEAE was headache. SKYLIGHT 1 and SKYLIGHT 2 are ongoing studies, with patients completing a treatment duration for 52 weeks. Detailed results will be submitted for publication and for consideration at upcoming medical meetings following the 52-week analyses.
'We are encouraged by these results for fezolinetant, which mark the first Phase 3 data in a new category of selective neurokinin-3 (NK3)-targeted treatments for moderate to severe vasomotor symptoms,' said
VMS are the most common symptoms associated with menopause, affecting more than 50 percent of women 40 to 64 years of age.1,2 VMS can have a considerable effect on a woman's comfort and sleep which can lead to fatigue, mood changes, and effect work and relationships.1,3
Fezolinetant is an investigational, selective neurokinin-3 receptor (NK3R) antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center in the hypothalamus of the brain to treat VMS associated with menopause. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of VMS associated with menopause.
SKYLIGHT 1 and SKYLIGHT 2 are double-blinded and placebo-controlled studies evaluating 30 and 45 mg fezolinetant administered once-daily for the first 12 weeks followed by 40-week active treatment extension periods.
About BRIGHT SKY PHASE 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), have enrolled 1,028 women with moderate to severe vasomotor symptoms (VMS). The trials are double-blinded and placebo-controlled for the first 12 weeks followed by 40-week active treatment extension periods. Women were enrolled at 307 sites within the US,
About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal compound in clinical development for the potential treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking NKB binding on the KNDy neuron to moderate neuronal activity in the thermoregulatory center of the brain to reduce the frequency and severity of VMS associated with menopause.
The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
About Astellas
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