UK's KaNDy Therapeutics funds mid-stage trial of HRT 'replacement'

UK biotech KaNDy Therapeutics has closed a third funding round, raising a further £25 million to take its non-hormonal drug candidate NT-814 for menopause symptoms through to phase 3 and a potential IPO or deal with big pharma.

Based in Stevenage, the biotech closed the funding round including new backer Longitude Capital, and existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed.

KaNDy  Therapeutics said it now has the funds to take NT-814, for multiple symptoms of the menopause, through a multi-country phase 2b dose-ranging study.

The trial is due to start recruiting patients in Q4 2018, with headline results expected in late 2019.

Speaking to pharmaphorum at the AngloNordic Life Science conference earlier this summer, CEO Mary Kerr said KaNDy could then finance phase 3 development through an IPO, or with a significant investment from big pharma.

Earlier this year there were rumours that Allergan was considering buying the UK biotech for $400 million.

NT-814 does have a rival – Astellas has fezolinetant in mid-stage development, a twice-daily NK3 receptor antagonist for menopause-related hot flashes.

But Kerr said that NT-814 is likely to have an advantage if both drugs make it to market, as by working on both the NK1 and NK3 receptors it will help with sleep and mood problems, as well as hot flashes.

She told the conference that NT-814 could be a "replacement" for hormone replacement therapy (HRT), which is linked with an increased risk of problems such as blood clots, cardiovascular disease and breast cancer.

In a phase 2a study a group of women taking NT-814 saw hot flashes reduced by 62% from baseline after one week and 84% after two weeks. Women in placebo groups showed a reduction of 24% and 37% from baseline at week one and week two respectively.

Women on NT-814 had fewer night time awakenings -  a reduction of 58% from baseline vs. 17% in placebo in week one and an 81% reduction from baseline vs. 32% for placebo in week two.

She said at the conference: “The reduction is significant – it (NT-814) turns some kind of switch mechanism.”

NT-814 was part of a portfolio of NK class drugs developed by GlaxoSmithKline, which were originally under investigation as mental health medicines.

GSK decided to spin this portfolio out into a biotech called NeRRe in 2012, which last year spun out KaNDy to take NT-814 through the remainder of clinical development as a women's health drug.