Astellas’ fezolinetant fails to meet pre-defined endpoints for efficacy in Moonlight clinical trial

Astellas Pharma recently announced results from the ongoing phase-III Moonlight clinical trial investigating the efficacy and safety of fezolinetant, an investigational oral, non-hormonal compound being studied for the treatment of moderate-to-severe vasomotor symptoms associated with menopause in women in Asia, the company said in a statement.

Based on the 12-week data analysis in 302 participants, fezolinetant 30 mg once daily (QD) in women in China, Korea and Taiwan did not meet the pre-defined endpoints for efficacy. While numerical improvements from baseline were observed in the fezolinetant 30 mg treatment group, the results did not meet statistical significance. The 12-week safety data in this study are aligned with what was previously observed with fezolinetant. Detailed results will be submitted for publication following completion of the 24-week analyses, added the statement.

“We are evaluating the results and look forward to reviewing the full data set once the study is complete,” said Nancy Martin, MD, PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas, in the statement.

The statement further said that Moonlight 1 is an ongoing randomised phase-III clinical trial evaluating the efficacy and safety of fezolinetant in 302 women in China, Korea and Taiwan who take fezolinetant 30 mg QD 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. Specifically, the Moonlight 1 study is being conducted to support registration in China, Korea and Taiwan. As previously reported, the results from two pivotal phase-III clinical trials, Skylight 1 and Skylight 2, along with the findings from the long-term safety study, Skylight 4, will provide the foundational data for regulatory submissions in the US and Europe.

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. The efficacy and safety of fezolinetant are under investigation and have not been established, it added.

This result will have no impact on the financial forecasts of the current fiscal year ending 31st March, 2022, the statement concluded.