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KaNDy Therapeutics announces positive clinical data with lead candidate NT-814 for the treatment of symptoms of the menopause

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~Phase Ib/IIa data showed rapid and highly significant reductions in the frequency and severity of hot flashes and the number of night time awakenings~

~NT-814 is being developed to provide a valid alternative to hormone replacement therapy and will now move into a Phase IIb trial~

~KaNDy Therapeutics also announces it will be attending the 16th World Congress on Menopause in Vancouver from 6-9 June~

KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase Ib/IIa clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.

Results from the trial provide compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as HF, and night time awakenings.

Based on these results, KaNDy Therapeutics intends to advance NT-814 into a fully powered Phase IIb definitive dose-ranging study in patients suffering from debilitating symptoms of the menopause. The Phase IIb trial will begin later this year.

The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPUs) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe hot flashes/flushes (HF) per week were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo.