Astellas Pharma has dosed the first subject in the Phase III STARLIGHT 2 clinical trial of an oral, non-hormonal treatment candidate, fezolinetant, for menopausal vasomotor symptoms (VMS) in Japanese women.
Fezolinetant is designed to alleviate symptoms such as hot flashes and night sweats by targeting the brain’s temperature control centre or the hypothalamus.
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It hinders the neurokinin B (NKB) that attaches to the kisspeptin / neurokinin/dynorphin (KNDy) neuron to reinstate the balance in the hypothalamus.
The 12-week, parallel-group, double-blind, randomised, placebo-controlled, multicentre STARLIGHT 2 trial is set to assess fezolinetant’s superiority compared to placebo as well as analyse its safety.
It will involve nearly 390 subjects who will be randomised into three groups to receive either a low or high dose of fezolinetant or placebo.
The mean change in the VMS frequency from baseline to week eight with a total treatment period of 12 weeks is the trial’s primary endpoint.
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By GlobalDataIn addition to STARLIGHT 2, the company is progressing STARLIGHT 3 trial of fezolinetant for a treatment period of 52 weeks.
The double-blind, randomised, placebo-controlled, parallel-group, multicentre STARLIGHT 3 study will analyse the safety and tolerability of fezolinetant for the same patient population.
Around 260 participants will be enrolled, with the main endpoint being the frequency and severity of adverse events over one year.
The dosing regimen for these Phase III studies is informed by global research data, including results from the completed STARLIGHT Phase IIb trial, which involved 147 patients.
Astellas vice-president and biopharma development head Marci English said: “VMS associated with menopause affects millions of women in Japan.
“We are excited the STARLIGHT Phase III clinical studies are underway, bringing us one step closer to making this novel, nonhormonal treatment option available in Japan for women experiencing VMS associated with menopause.”
Last November, the company reported data from the Phase III GATHER2 clinical trial where Izervay intravitreal solution reduced geographic atrophy (GA) lesion growth rate in individuals with GA secondary to age-related macular degeneration (AMD).
