Astellas scores a pair of trial wins for menopausal hot flash med, raising the pitch of looming Bayer standoff
Astellas took a flier on women’s health when it bought out Ogeda and nonhormonal menopause candidate fezolinetant in early 2017 and then doubled down during a major restructuring just over a year later. Now, an early peek at late-stage studies bode well for Astellas’ chances — and it could be teeing up a fight with Bayer.
In a pair of Phase III studies dubbed SKYLIGHT 1 and 2, two doses of Astellas’ fezolinetant topped placebo in reducing the frequency and severity of hot flashes in menopausal women at one- and three-month check ins, according to topline data unveiled Friday.
The drug went 4-for-4 on its primary endpoints in both studies, which tested once-daily, 30- and 45-mg doses of fezolinetant. The trials are ongoing and will dose patients through 52 weeks.
Fezolinetant, a NK3R inhibitor that works by blocking a key peptide associated with downstream thermoregulation in the hypothalamus, is angling to become the first nonhormonal therapy for menopausal hot flashes, Astellas said. The full 52-week results of the SKYLIGHT studies will be presented at a future medical meeting.
A late-stage win for Astellas is setting up a battle ahead with Bayer and its own nonhormonal menopause therapy, NT-814, which the German drugmaker believes could eventually be a blockbuster.
Astellas acquired fezolinetant as part of a $870 million buyout of Belgian biotech Ogeda back in April 2017. At the time, a Phase IIa study of the drug showed a 93% reduction in hot flashes for the fezolinetant group at week 12 compared to 54% on placebo. The reduction in severity of hot flashes at week 12 was 70% for the drug arm and 23% in the placebo group.
Those results were impressive enough for Astellas to plop down a big down payment on women’s health, an area that has seen little innovation in recent years. With Phase III in the works, fezolinetant became a central part of the company’s business plan during CEO Kenji Yasukawa’s expansive restructuring that was launched in mid-2018.
Meanwhile, Bayer took its own big bet on women’s health R&D in August when it dropped $875 million in cash and future milestones for KaNDy Therapeutics and NT-814, an NK1/3 inhibitor angling for the same underserved market as fezolinetant. Phase IIb data for 120- and 160-mg doses of the drug at the time showed that it “reduced the frequency and severity of VMS and significantly improved quality of life, mood and sleep, in postmenopausal women,” KaNDy said.
Bayer has pinned blockbuster aspirations on the med, and with such high hopes a standoff with Astellas appears likely. However, KaNDy CEO Mary Kerr told Endpoints News in August she didn’t view Astellas as a competitor given the clinical need.
“It’s an area of huge unmet need and it’s great to see non-hormonal options coming in for women,” she said. “Women have waited for this for a long long time, and we hope that finally we get a non-hormonal alternative to market.”