Positive results for Astellas’ Fezolinetant

Trial involved over 450 women across Europe, Turkey and Canada who were unsuitable for hormone therapy

Astellas Pharma has announced positive results from its phase 3b DAYLIGHT study.

The clinical trial is researching fezolinetant – an investigational oral, non-hormonal compound for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause.

DAYLIGHT is a phase 3b, double-blind, randomised, placebo-controlled study assessing the efficacy and safety of fezolinetant among menopausal women aged 40 to 65 years.

Research involved over 450 women across Europe, Turkey and Canada, who were considered unsuitable for hormone therapy. The therapy duly met its primary aim of demonstrating a statistically significant reduction in frequency of moderate to severe VMS at week 24 when incorporating a 45mg daily dose of fezolinetant.

Meanwhile, serious treatment emergent adverse events occurred in fewer than 5% of patients, while the most frequent adverse events were headaches or COVID-19.

Fezolinetant works by obstructing neurokinin B binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the thermoregulatory centre of the brain.

Marci English, vice president, head of biopharma development at Astellas, was optimistic about the effectiveness of fezolinetant: “We are delighted the initial assessment of the DAYLIGHT study further validates the role of fezolinetant in reducing the frequency of moderate to severe VMS due to menopause.”

She added: “These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot or choose not to take hormone therapy.”

Fezolinetant was approved under the brand name VEOZAH by the US Food and Drug Administration earlier this year and Astellas is seeking regulatory approval for the therapy in several other countries and regions, including Europe.