Astellas’ investigational non-hormonal treatment demonstrates reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) associated with menopause

TOKYO, September 22, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 12-week results (S-13) from the pivotal Phase 3 SKYLIGHT 2™ clinical trial of fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause on Friday, September 24, 2021 during the Top-Scoring Abstract Presentations at The North American Menopause Society 2021 Annual Meeting in Washington, D.C. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1

Findings showed fezolinetant 30 and 45 mg administered once-daily met the co-primary endpoints of the study, demonstrating a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS at weeks 4 and 12 versus placebo. Results also showed that improvement in VMS frequency and severity greater than placebo was observed through the 12-week placebo-controlled period, with improvement observed as early as one week after treatment onset for both doses.

Fezolinetant is an investigational, non-hormonal selective neurokinin-3 receptor (NK3R) antagonist that blocks a specific receptor in the temperature control center of the brain (the hypothalamus) to reduce the frequency and severity of VMS associated with menopause.2,3,4,5

“VMS are the most common menopausal symptoms for which women seek treatment, yet there have been limited non-hormonal options available to women and healthcare providers,” said Dr. Nanette Santoro, M.D., Professor and Chair, University of Colorado School of Medicine. “These results from the SKYLIGHT 2 study show that fezolinetant has the potential to help reduce frequency and severity of moderate to severe VMS.”

For the co-primary endpoint of reduction in mean frequency of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -1.82 (p=<0.001) and -1.86 (p=<0.001) mean change per day at weeks 4 and 12, respectively. At the 45 mg dose, fezolinetant showed a -2.55 (p=<0.001) and -2.53 (p=<0.001) mean change per day in VMS frequency versus placebo at weeks 4 and 12, respectively.

Additionally, for the co-primary endpoint of reduction in mean severity of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -0.15 (p=<0.021) and -0.16 (p=0.049) mean change per day at weeks 4 and 12, respectively. The 45 mg dose of fezolinetant showed a -0.29 (p=<0.001) mean change in severity per day versus placebo at both weeks 4 and 12.

Treatment emergent adverse events (TEAE) were reported by 40 percent, 36 percent and 32 percent of individuals in the SKYLIGHT 2 trial in the 30 mg, 45 mg and placebo groups, respectively. Headache was the most common TEAE in the fezolinetant groups and was reported by 3 percent, 4 percent and 2 percent in the 30 mg, 45 mg and placebo groups, respectively. Serious TEAEs occurred in less than 2 percent of patients in the fezolinetant groups and there were no drug-related serious TEAEs. Detailed safety results will be available following the completion of the fezolinetant Phase 3 program, which will also include the SKYLIGHT 1™ and SKYLIGHT 4™ studies.

“As we work to advance the development of an NK3R targeted treatment for VMS associated with menopause, we are encouraged by the 12-week results of the SKYLIGHT 2 study,” said Andrew Krivoshik, Senior Vice President and Head of Development Therapeutic Areas, Astellas. “We look forward to continuing to progress our Phase 3 development program and potentially introducing a first-in-class, non-hormonal treatment option for moderate to severe vasomotor symptoms associated with menopause.”

 

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