Astellas : Phase 3 Study Of Fezolinetant On VMS Associated With Menopause Did Not Show Efficacy

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that 12-week data from phase 3 MOONLIGHT 1 study of fezolinetant 30 mg for the nonhormonal treatment of vasomotor symptoms in women in Asia did not meet the pre-defined endpoints for efficacy. The numerical improvements from baseline were observed in the fezolinetant 30 mg treatment group, But the results did not meet statistical significance. The 12-week safety data in this study are aligned with what was previously observed with fezolinetant.

MOONLIGHT 1 is an ongoing randomized Phase 3 clinical trial evaluating the efficacy and safety of fezolinetant in 302 women in China, Korea and Taiwan who take fezolinetant 30 mg once daily for 24 weeks. The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period.

Fezolinetant is an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS), in women in Asia. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.

The company noted that the result will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.