UK-based biotech company KaNDy Therapeutics has reported positive results from the Phase Ib/IIa RELENT-1 clinical trial of NT-814 to treat symptoms of menopause.
The randomised, double-blind, placebo-controlled trial was carried out at three clinical pharmacology units (CPUs) in the US.
It enrolled 76 women aged 41 to 64 years experiencing between seven and 20 moderate or severe hot flashes / flushes (HF) per week. The patients were randomised to receive one of four escalating doses of NT-814 or placebo as part of the trial.
The new results have showed that treatment with NT-814 once daily for two weeks at the most effective dose resulted in rapid and highly significant reductions in the frequency of the menopause such as vasomotor symptoms (VMS), also known as HF.
NT-814 has also reduced the severity of HF, with a reduction of 23% from baseline in average HF severity vs 9% for placebo in week one, and a 50% reduction from baseline vs 16% for placebo in week two.
The number of night time awakenings has also been minimised, with a reduction of 58% from baseline vs 17% for placebo in week one and an 81% reduction from baseline vs 32% for placebo in week two.
During the course of the trial, NT-814 was well tolerated with no safety concerns reported across the dose range, including routine safety labs, liver function tests, ECGs and vital signs.
KaNDY Therapeutics clinical advisor Richard Anderson said: “These are very promising results which suggest that NT-814, a novel once daily treatment taken orally, may offer women with debilitating symptoms of the menopause, a real alternative to hormone replacement therapy (HRT).
“In contrast to HRT, which can take weeks or months to be fully effective, both hot flashes and night-time awakenings responded rapidly and with big changes with NT-814.”
NT-814 is an orally administered, potent and selective small molecule dual antagonist featuring the neurokinin-1 and 3 receptors currently being developed by KaNDy as a therapy for various health conditions of women.