Trial suggests KaNDy’s menopause drug could be better than HRT

Mary Kerr, NeRRe
KaNDy Therapeutics managing director Mary Kerr, Ph.D. (KaNDy Therapeutics)

New women’s health biotech KaNDy Therapeutics—rumored to have attracted buyout interest from Allergan—has just reported data on its lead product that could enhance its allure.

The phase 1b/2a trial of NT-814 for the treatment of menopause symptoms has hit the mark, with reductions in the frequency and severity of hot flashes and night-time awakenings that suggest it could be an effective alternative to hormone replacement therapy.

NT-814 acts as a dual neurokinin-1,3 receptor antagonist and is thought to work by changing the activity of estrogen-sensitive neurons in the hypothalamus area of the brain, alleviating vasomotor symptoms (VMS) without having to administer hormones themselves.

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While still undoubtedly of value to some women with VMS, HRT has fallen out of favor after being linked to an increased risk of breast cancer, heart disease, stroke and blood clots in the Women’s Health Initiative (WHI) study reported more than 15 years ago.  Later analyses pointed to a much better risk:benefit ratio for younger menopausal women (aged 50 to 59), but there is still resistance to go down the HRT route for VMS.

The problem is there is no real alternative to HRT available yet—although KaNDy thinks it is on course to address that with NKT-814, which will start a phase 2b trial later this year.

In the 76-patient phase 1b/2a trial, the frequency of VMS was cut by 62% from baseline compared to 24% with placebo in the first seven days, with the effect increasing to an 84% reduction for the drug versus 37% in the control group in week two.

That puts its efficacy on a par with historical data with HRT, which caused around a 75% reduction in hot flashes in a meta-analysis of clinical trials, but with a much quicker onset as HRT can take “weeks or months” to kick in, according to KanDy’s clinical advisor Richard Anderson, who is professor of reproductive science at the University of Edinburgh in Scotland.

By the second week, KaNDy’s drug also reduced the severity of hot flashes by 50% compared to 16% for placebo, and nighttime awakenings were cut 81% versus 32%, respectively.

“These are very promising results which suggest that NT-814, a novel once daily treatment taken orally, may offer women with debilitating symptoms of the menopause, a real alternative to…HRT,” said Professor Anderson.

Given the sheer scale of demand for ways to alleviate menopausal symptoms, the new results are a big boost for KaNDy, which was formed last year as a spin-out from U.K. biotech NeRRe Therapeutics—itself a spin-out from GlaxoSmithKline—and is led by Mary Kerr, Ph.D.

There’s speculation the results could also flush out more suitors for the company, along with Allergan’s rumored interest, amid what Kerr has said is a growing interest in women’s health by the drug industry.

Last year, Astellas agreed a $500 million upfront deal to buy Belgian biotech Ogeda on the strength of midstage data for its selective neurokinin-3 antagonist fezolinetant candidate on menopausal hot flashes, with another $300 million in the offing if the program meets clinical and regulatory milestones.

There have also been IPOs in recent months for endometriosis drug developer Myovant and ObsEva, a reproductive health specialist.