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KANDY THERAPEUTICS ANNOUNCES POSITIVE PHASE 2B DATA IN POST-MENOPAUSAL WOMEN WITH ITS LEAD NON-HORMONAL PRODUCT NT-814

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KANDY THERAPEUTICS ANNOUNCES POSITIVE PHASE 2B DATA IN POST-MENOPAUSAL WOMEN WITH ITS LEAD NON-HORMONAL PRODUCT NT-814

KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814

~Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period~

~Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints~

~ All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3 ~

Stevenage, UK, 13 January 2020 – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.

Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.

The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada. One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:

• Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p