Astellas Pharma has reported positive topline results from the Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 clinical trials of an oral non-hormonal compound, fezolinetant, for treating moderate to severe vasomotor symptoms (VMS), specifically hot flashes associated with menopause.
An investigational, selective neurokinin-3 receptor (NK3R) antagonist, fezolinetant is in the clinical development stage.
VMS are the most common symptoms of menopause and affect more than 50% of women aged 40 to 64 years.
The ongoing, double-blinded and placebo-controlled SKYLIGHT 1 and SKYLIGHT 2 studies analysed 30mg and 45mg fezolinetant administered once-daily for 12 weeks. It was followed by 40-week active treatment extension periods.
The studies enrolled 1,028 women with moderate to severe VMS at 307 sites in the US, Canada and Europe.
Results showed that both trials met all four co-primary endpoints. It showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS to week four and week 12 for women receiving fezolinetant versus a placebo.
Furthermore, serious treatment-emergent adverse events (TEAE) occurred in less than 2% of patients with headache being the most common TEAE.
The studies are progressing with patients completing a treatment duration of 52 weeks.
The company noted that the detailed results will be reported following the 52-week analyses.
Astellas Pharma senior vice-president Salim Mujais said: “We are encouraged by these results for fezolinetant, which mark the first Phase III data in a new category of selective neurokinin-3 (NK3)-targeted treatments for moderate to severe vasomotor symptoms.
“Vasomotor symptoms can add a significant burden and impact the quality of life for women. We are hopeful that with fezolinetant, we will be able to deliver a novel non-hormonal treatment option.”
Last July, Astellas received a grant from the US National Institutes of Health (NIH) unit to support two Phase I clinical trials of ASP8062 as a maintenance treatment for opioid use disorder (OUD).