Image: Mary Kerr KANDY THERAPEUTICS
For women experiencing symptoms of menopause — hot flashes, sleep and mood problems among others — hormone replacement therapy is often the only relief. But it comes with a cost: From breast swelling to cardiovascular risks, the side effects of such treatment are well known.
KaNDy Therapeutics, a UK biotech created to address this very problem, has just raised $32 million (£25 million) to test out a non-hormonal approach.
“It could well represent, when we look back on it, one of the biggest breakthroughs in women’s health — assuming that it’s safe in long term studies,” CEO Mary Kerr tells me.
While execs are calling this round a Series C, it’s actually the first funding KaNDy is receiving as a standalone company after it was spun out of NeRRe Therapeutics last year with the neurokinin-1,3 receptor antagonist NT-814. NeRRe, in turn, is a GlaxoSmithKline spinout developing neurokinin-1 antagonists.
KaNDy is a virtual company run by a lean team at NeRRe, where Kerr is also CEO. And the same team — complete with a few more hires — will be seeing NT-814 through clinical proof-of-concept.
The upcoming dose-finding Phase IIb study, scheduled to launch this year in the US, Canada and the UK, is designed with FDA-mandated endpoints in mind. The money, Kerr tells me, will also cover things like chemistry, manufacturing and controls development such that the drug will be “fully Phase III ready” by mid-2020.
Unlike hormone replacement therapies, which has systemic effects, NT-814 is a small molecule drug that selectively switches off a group of neurons concentrated in the hypothalamus, promising to shut down symptoms of menopause without causing problems elsewhere.
“At peak, the HRT market was one of the original blockbuster markets,” she says. “A compound that works that is as effective as estrogen, but has a better safety profile has huge potential both in terms of value but also in the number of women who will benefit not just in the US but also globally because it’s a global phenomenon.”
California-based Longitude Capital chipped in for the round, joining existing European investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed. Having a “strong syndicate” means the company can take its time getting some data before deciding its next move, with IPO being one option that’s “firmly on the radar,” Kerr says.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 32,500+ biopharma pros who read Endpoints News by email every day.Free Subscription