Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 trials of ESN 364 meet endpoints in menopause.- Astellas Pharma

Astellas Pharma announced positive topline results from the Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 clinical trials for ESN 364 (fezolinetant), an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) – i.e., hot flashes associated with menopause. 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. 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.