Phase III study shows safety of fezolinetant as non-hormonal treatment of VMS

Astellas has announced topline results from the Skylight 4 trial investigating the long-term safety of fezolinetant as a treatment of moderate to severe vasomotor symptoms associated with menopause (VMS).

VMS, characterised by hot flushes and/or night sweats, are common symptoms of menopause, experienced by more than half of women 40 to 64 years of age worldwide.

Skylight 4 is a randomised, placebo-controlled, double-blind Phase III clinical trial of over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women as a treatment for relief of VMS associated with menopause. The study’s primary objectives were to evaluate the effect of fezolinetant on endometrial health and the long-term safety and tolerability of the drug. The primary endpoint assessing endometrial health was achieved and the most common treatment emergent adverse events (TEAE) were headache and COVID-19, consistent with placebo. The topline data further characterise the long-term safety profile of fezolinetant and will inform future regulatory filings.

“With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, non-hormonal treatment option for moderate to severe VMS associated with menopause,” commented Dr Nancy Martin, PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas.

The Skylight 4 findings, along with the results from two pivotal Phase III clinical trials, Skylight 1 and Skylight 2, will provide the foundational data for regulatory submissions in the US and Europe.

“Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area,” said Dr Genevieve Neal-Perry, Chair, UNC School of Medicine Department of Obstetrics and Gynecology. “With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, non-hormonal treatment option for moderate to severe VMS associated with menopause.”

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. If approved by regulatory authorities, fezolinetant would be a first-in-class, non-hormonal treatment option to reduce the frequency and severity of VMS associated with menopause.

Detailed results from the trial will be submitted for publication and for consideration at upcoming medical meetings.