Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) has initiated dosing for the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound aimed at addressing vasomotor symptoms (VMS) linked with menopause in Japanese women.
In Japan, two Phase 3 clinical trials are currently underway. STARLIGHT 2 will examine the efficacy and safety of fezolinetant administered once-daily over 12 weeks. STARLIGHT 3, on the other hand, will evaluate the safety and tolerability of fezolinetant administered once-daily over 52 weeks.
Marci English, Vice President and Head of BioPharma Development at Astellas, commented, “VMS associated with menopause impacts a substantial number of women in Japan. We are pleased that the STARLIGHT Phase 3 clinical trials have commenced, bringing us closer to providing this innovative, nonhormonal treatment option to Japanese women experiencing VMS associated with menopause.”
The dosing for the STARLIGHT Phase 3 clinical trials was established based on available global data, including insights from the STARLIGHT Phase 2b study (NCT05034042), which enrolled 147 patients and concluded in 2022. Primary findings from the STARLIGHT Phase 2b study were presented at the Annual Meeting of the Japan Society for Menopause and Women’s Health on December 3, 2023.
About STARLIGHT 2: STARLIGHT 2 (NCT06206408) is a 12-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study designed to assess the superiority of fezolinetant over placebo and to evaluate the safety of fezolinetant in Japanese women experiencing VMS associated with menopause. Approximately 390 participants will be randomized to this study, with 130 participants per treatment arm (fezolinetant low dose, fezolinetant high dose, or placebo). The primary endpoint is the mean change in the frequency of VMS from baseline to week 8, with a total treatment duration of 12 weeks.
About STARLIGHT 3: STARLIGHT 3 (NCT06206421) is a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study aimed at assessing the safety and tolerability of fezolinetant in Japanese women experiencing VMS associated with menopause. Approximately 260 participants will be randomized to this study, with 130 participants per treatment arm (fezolinetant or placebo). The primary endpoint is the frequency and severity of adverse events over 52 weeks.
About Vasomotor Symptoms (VMS): VMS, commonly known as hot flashes and/or night sweats, are prevalent symptoms of menopause that can significantly disrupt women’s daily activities and overall quality of life. Worldwide, more than half of women aged 40 to 64 experience VMS. In Japan, approximately 25% to 37% of women experience these symptoms during or after the menopausal transition.
About Fezolinetant: Fezolinetant is an investigational oral, nonhormonal medication currently undergoing clinical development in Japan for the treatment of VMS associated with menopause. VMS, also referred to as hot flashes or night sweats, are targeted by fezolinetant through its mechanism of action, which involves blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron. This action helps restore balance in the brain’s temperature control center (the hypothalamus), thereby reducing the frequency and intensity of hot flashes and night sweats. It should be noted that there is no guarantee that the agent will receive regulatory approval in Japan or become commercially available for the uses being investigated.
