Astellas Pharma has initiated the SKYLIGHT 1 Phase III trial to evaluate fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS), hot flashes, and night sweats associated with the menopause.
Fezolinetant is an investigational oral, non-hormonal compound and a selective neurokinin-3 (NK3) receptor antagonist.
As part of the first trials of the BRIGHT SKY clinical development programme, the efficacy and safety of 30mg and 45mg once-daily (QD) fezolinetant will be evaluated for its ability to reduce the frequency and severity of VMS.
Astellas Pharma Medical Specialties senior vice-president and Therapeutic Area head Salim Mujais said: “There are currently limited non-hormonal options for managing vasomotor symptoms, which can be quite disruptive and often interfere with daily life.
“With the initiation of our Phase III fezolinetant programme, we move further towards our goal of providing women with a non-hormonal treatment for moderate-to-severe hot flashes.”
The global BRIGHT SKY programme will launch with Phase III SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4 clinical trials that will enrol postmenopausal women with VMS.
The SKYLIGHT 1 and SKYLIGHT 2 pivotal trials will each enrol about 450 women with moderate-to-severe VMS. They will be double-blinded and placebo-controlled for the first 12 weeks, followed by non-controlled 40-week extension periods.
Women will be enrolled at roughly 200 sites in the US, Canada, and Europe for each pivotal trial.
The 52-week double-blinded and placebo-controlled SKYLIGHT 4 trial will enrol around 1,150 women with VMS at approximately 250 sites.
Fezolinetant blocks neurokinin B (NKB) signalling and normalises KNDy (kisspeptin/NKB/dynorphin) neuron activity, which modulates the temperature control centre and reduces the frequency and severity of hot flashes.