Astellas Initiates P-III BRIGHT SKY Clinical Program for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms

Shots:

• Astellas to initiate global BRIGHT SKY program which includes three P-III studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) and will assess fezolinetant (30/45mg, qd) in postmenopausal women with VMS i.e, hot flashes and night sweats associated with menopause.
• The P-III SKYLIGHT 1&2 will assess Fezolinetant vs PBO for 12wks. and will each enroll ~450 women followed by non-controlled 40wks. extension period across 200 sites. The P-III SKYLIGHT 4 study will evaluate Fezolinetant vs PBO in ~ 1,150 women with VMS to investigate long-term safety across 250 sites
• Fezolinetant is an oral, non-hormonal therapy which acts by targeting neurokinin-3 (NK3) receptor and normalizing KNDy neuron activity further modulating the temperature control center and reducing the frequency + severity of hot flashes

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