Astellas Pharma has announced the initiation and dosing of the first patient in its SKYLIGHT1 Phase III pivotal trial for fezolinetant.
The investigational oral, non-hormonal compound is being studied for the treatment of moderate-to-severe menopause related vasomotor symptoms (VMS), such as hot flashes and night sweats.
The first trials of the programme will evaluate the efficacy and safety of 30 and 45 mg once-daily (QD) doses of fezolinetant in reducing VMS frequency and severity.
“There are currently limited non-hormonal options for managing vasomotor symptoms, which can be quite disruptive and often interfere with daily life,” said Salim Mujais, senior vice president and therapeutic area head, medical specialties, Astellas. “With the initiation of our Phase III fezolinetant program, we move further towards our goal of providing women with a non-hormonal treatment for moderate-to-severe hot flashes.”
The global BRIGHT SKY program will launch with three Phase III clinical trials overall; SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4, which will each enroll approximately 450 women with moderate-to-severe VMS and will be double-blinded and placebo-controlled for the first 12 weeks followed by non-controlled 40-week extension periods.
Globally, approximately 57% of women 40 to 64 years of age have reported the occurrence of hot flashes (also known as hot flushes) and sweating, symptoms which can have a considerable effect on women’s comfort and sleep and can lead to anxiety, irritability, loss of productivity and depression.