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Astellas Pharma's Fezolinetant Topped Placebo For Reducing Severity Of Menopausal Hot Flash In Phase 3 Studies

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  • Astellas Pharma Plc (OTCMKTS: ALPMY) has reported positive topline results from two Phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2, evaluating an oral non-hormonal compound, fezolinetant, for treating moderate to severe vasomotor symptoms (VMS), specifically hot flashes associated with menopause.
  • Results showed that both trials met all four co-primary endpoints. It showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS to week four and week 12 for women receiving fezolinetant versus a placebo.
  • Furthermore, serious treatment-emergent adverse events occurred in less than 2% of patients, with headache being the most common adverse event.
  • The studies are progressing with patients completing a treatment duration of 52 weeks; results will be presented at a future medical meeting.
  • Fezolinetant is an NK3R inhibitor that blocks an essential peptide associated with downstream thermoregulation in the hypothalamus. 
  • Price Action: ALPMY shares gained 1.9% at $17.08 in market trading hours on the last check Friday.
 

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Posted-In: Phase 3 StudyBiotech News FDA General

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