~ Treatment with NT-814 resulted in immediate improvements in bothersome post-menopausal symptoms~
~ Phase Ib/IIa data showed rapid and significant reductions in the frequency and severity of hot flashes and the number of night time awakenings~
STEVENAGE, England -- KaNDy Therapeutics, a UK clinical-stage biotech company, announces the presentation of new clinical data from the Phase Ib/IIa proof of concept clinical trial with its lead non-hormonal drug candidate, NT-814, at The North American Menopause Society 2018 Annual Meeting taking place from 3-6 October 2018 in San Diego, US.
Data from the Phase Ib/IIa RELENT-1 study, presented by Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics, demonstrate compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, being developed to provide a safe and effective alternative to hormone replacement therapy (HRT), produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as hot flush or flash (HF), and night time awakenings.
The effects of treatment with NT-814 were immediate in onset, being both statistically significant and clinically relevant as soon as the first day of treatment. In contrast, studies with HRT have shown onset is within weeks or months.
The Phase Ib/IIa data also demonstrated that treatment with NT-814, taken once daily for two weeks at the most effective dose evaluated, resulted in rapid and significant reductions in:
the frequency of HF, with a reduction of 62% from baseline in the number of moderate and severe HF vs 24% for placebo in Week 1 (p<0.0014) and an 84% reduction from baseline vs 37% for placebo in week 2 (p<0.0002)
the severity of HF, with a reduction of 23% from baseline in average HF severity vs 9% for placebo in week 1 (p<0.015) and a 50% reduction from baseline vs 16% for placebo in Week 2 (p<0.0004)
the number of night time awakenings, with a reduction of 58% from baseline vs 17% for placebo in Week 1 (p< 0.0022) and an 81% reduction from baseline vs 32% for placebo in Week 2 (p< 0.0005).
NT-814 was found to be well-tolerated and no safety concerns were identified in the study.
Commenting on the data, Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics said: “These data presented today provide very compelling evidence to support the use of NT-814 to treat bothersome symptoms of the menopause. The fact that the effects of treatment are seen from the first day is extremely promising and positions NT-814 as a real alternative to HRT which can take weeks or months to be fully effective. We are looking forward to progressing this candidate through clinical development, in order to make this treatment commercially available as soon as possible.”
Dr Hadine Joffe, Paula A. Johnson Associate Professor of Psychiatry in the Field of Women’s Health, Harvard Medical School, Executive Director of the Connors Center for Women’s Health, Brigham and Women's Hospital, and Scientific and Clinical Advisor to KaNDy Therapeutics added: “The results generated thus far are indeed promising. HRT is effective and has a number of safety concerns and is slow in onset, so there is a real need for a safe, non-hormonal treatment option which acts quickly to relieve symptoms. This study has shown that NT-814 not only results in rapid and significant reductions in both hot flashes and night-time awakenings, but also that the effects of treatment are immediate. I believe NT-814 could be a potentially breakthrough non-hormonal option for the millions of women who suffer with debilitating symptoms related to menopause.”
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 is expected to begin later this year.
The full abstract can be viewed on The NAMS website: https://www.menopause.org/annual-meetings/2018-meeting/meeting-abstracts
About the RELENT-1 Study: The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPU) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe HFs per day were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo in four cohorts. Study drug was taken once daily in the morning for 14 days, the first seven of which were resident in the CPU. Subjects completed diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses VMS by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that, because of the absence of oestrogen in menopausal women, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal VMS, are debilitating for women often over many years and associated with significant healthcare and economic costs.
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700