Astellas ‘encouraged’ by menopause symptom treatment results in China

September 5, 2022 - 4 minutes
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Astellas Pharma Inc. has announced topline results from its phase 3 MOONLIGHT 3 clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

MOONLIGHT 3 is a 52-week single-arm phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study’s primary endpoint is the frequency and severity of adverse events (AEs), which were generally consistent with previous phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. 

“The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas, Astellas

“We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS.” 

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal phase 3 clinical trials, SKYLIGHT 1 and SKYLIGHT 2, and the phase 3 long-term safety study, SKYLIGHT 4.

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About the MOONLIGHT phase 3 clinical trials

MOONLIGHT 1 is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. 

A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3 is a 52-week single-arm phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China.

About the BRIGHT SKY phase 3 program

The BRIGHT SKY pivotal trials, SKYLIGHT 1 and SKYLIGHT 2, enrolled more than 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4 is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, more than 1,800 women with VMS were enrolled at more than 180 sites within the U.S., Canada and Europe.

About VMS Associated with Menopause

VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS. 

About Fezolinetant

Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause. 

The safety and efficacy of fezolinetant are under investigation and have not been established. 

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