Astellas Announces Positive Topline Results from Phase 3 SKYLIGHT 1™ and SKYLIGHT 2™ Trials of Fezolinetant, a Potential First-in-Class Oral Non-Hormonal Therapy for Menopausal Vasomotor Symptoms

Astellas Announces Positive Topline Results from Pivotal Phase III SKYLIGHT 1 and SKYLIGHT 2 Clinical Trials of Fezolinetant, a Potential First-in-Class Oral Non-Hormonal Investigational Product for the Treatment of Moderate to Severe Vasomotor Symptoms (Menopause-Related Hot Flashes)

Both studies met all four co-primary endpoints. Compared with placebo, women treated with fezolinetant 30 mg or 45 mg once daily (QD) showed significant reductions from baseline in the frequency and severity of moderate-to-severe vasomotor symptoms (VMS) at Weeks 4 and 12. Serious treatment-emergent adverse events (TEAEs) occurred in less than 2% of patients, with headache being the most common TEAE. Vasomotor symptoms (VMS) are the most common symptom of menopause, affecting more than 50% of women aged 40–64 years. VMS have a substantial impact on sleep, leading to fatigue and mood changes, and seriously affecting work performance and interpersonal relationships. Fezolinetant is an investigational selective neurokinin-3 receptor (NK3R) antagonist that treats menopause-associated VMS by modulating neuronal activity in the hypothalamic thermoregulatory center through blocking the binding of neurokinin B (NKB) to KNDy neurons. If approved by regulatory authorities, fezolinetant would be a first-in-class, non-hormonal therapeutic option capable of reducing the frequency and severity of menopause-related VMS. PharmCube NextPharma

SKYLIGHT 1 and SKYLIGHT 2 are two double-blind, placebo-controlled studies designed to evaluate the efficacy of once-daily oral fezolinetant at doses of 30 mg or 45 mg. The studies consist of two phases: after receiving 12 months of fezolinetant treatment, subjects will continue into a 40-week extended treatment study.

Astellas submitted the clinical trial application for fezolinetant in China in October 2019, and it is currently in Phase III clinical trials.

Dr. Salim Mujais, Senior Vice President and Therapeutic Area Head at Astellas, stated, “The results are highly encouraging, representing the first Phase III data for a novel selective neurokinin-3 (NK3) receptor antagonist targeting moderate-to-severe vasomotor symptoms. Vasomotor symptoms impose a significant burden on women and severely impact their quality of life. We hope to provide menopausal women with a new non-hormonal treatment option through fezolinetant.”Bio ValleyBioon.com）