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KaNDy Therapeutics Closes £25 Million Series C for Non-Hormonal Menopause Therapy

Proceeds to fund multi-country Phase 2b trial (Image: KaNDy Therapeutics).

As many as 75% of women experience post-menopausal vasomotor symptoms—commonly referred to as “hot flashes”—as they go through perimenopause and menopause, according to the American College of Obstetricians and Gynecologists. In an analysis of the Study of Women’s Health Across the Nation (SWAN), a multiracial, multiethnic observational study of the menopausal transition among 3,302 women across the US, researchers led by Nancy E. Avis, PhD, Professor of Social Sciences and Health Policy at Wake Forest School of Medicine, concluded that the median total vasomotor symptom duration was 7.4 years and was even longer—11.8 years—among women were premenopausal or early perimenopausal when they first reported frequent vasomotor symptoms.

Many women suffer from debilitating symptoms, multiple times a day, disturbing them at work, interrupting daily activities and severely impacting sleep. Hormone replacement therapy was a routinely prescribed treatment for vasomotor symptoms for decades, but, studies have shown that the common combination of estrogen and progestin increased the risk of certain serious conditions, including heart disease, stroke, blood clots and breast cancer, according to the Mayo Clinic.

UK-based KaNDy Therapeutics has been developing a non-hormonal treatment for multiple menopausal symptoms including vasomotor symptoms and night time awakening. The company announced today that it has closed on £25 million ($32.5 million) in Series C funding from new investor Longitude Capital and existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed. The proceeds will enable KaNDy Therapeutics to advance its lead candidate, NT-814, for treatment of multiple symptoms of menopause, through a multi-country Phase 2b dose-ranging study due to start recruiting patients in Q4 2018 with headline results expected in late 2019.

In 2017, KaNDY Therapeutics was spun out of NeRRe Therapeutics, which is developing a pipeline of neurokinin-1 receptor antagonists for the treatment of common, chronic and debilitating conditions. NeRRe was itself spun out of GlaxoSmithKline GSK in 2012. KaNDY Therapeutics is focused on optimizing the potential of its lead compound, NT-814, as a non-hormonal treatment for common, chronic debilitating female sex-hormone related conditions, with an initial focus on menopause symptoms. NT-814 addresses hot flashes by modulating a group of neurons in the hypothalamus known as “KNDy” neurons that, in the absence of estrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms.

Source: Labiotech

In June 2018, the company announced positive data from its Phase 1b/2a trial which showed that women who were treated with NT-814 once daily for two weeks at the most effective doses evaluated, experienced a rapid and profound reduction in key symptoms of the menopause, frequency and severity of hot flashes and the number of night time awakenings:

  • 62% reduction in the number of moderate and severe hot flashes vs 24% for placebo in week 1
    • 84% reduction vs 37% for placebo in week 2
  • 23% reduction in average hot flash severity vs 9% for placebo in week 1
    • 50% reduction vs 16% for placebo in week 2
  • 58% reduction in the number of night time awakenings vs 17% for placebo in week 1
    • 81% reduction vs 32% for placebo in week 2

We are delighted by the level of enthusiasm and financial support we have received from our investors and would like to welcome Longitude Capital into the syndicate and the board of directors. Our investors and the KaNDy management team are united by the common belief that NT-814 has the potential to be a transformational treatment for the millions of women worldwide who suffer debilitating symptoms of the menopause.

– Mary Kerr, PhD, CEO, KaNDy Therapeutics.

We were very pleased to participate in this funding round. We have been impressed with the data announced thus far, by KaNDy’s business strategy and the strong and experienced management team. We believe NT-814 has the potential to greatly improve the quality of life of millions of women worldwide and we look forward to supporting the company as it continues to progress this potentially transformational candidate through the clinic towards commercialization.

– Josh Richardson, MD, Managing Director, Longitude Capital.

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