KaNDy Therapeutics now has the finances it needs to start a phase 2b trial of its nonhormonal therapy for menopausal symptoms, after raising £25 million (around $32M) in its series C.
The startup—which earlier this year was linked to a possible takeover by Allergan before the company put its women’s health assets on the block—came into being last fall after U.K. company NeRRe Therapeutics streamlined its R&D portfolio by spinning off its women’s health assets into the new company.
Its lead candidate is NT-814, described as a first-in-class neurokinin-1,3 receptor antagonist with potential to treat postmenopausal vasomotor symptoms (PMVMS) such as hot flashes and nighttime awakenings. KaNDy says the cash injection will allow it to get a phase 2b dose-ranging trial going before the end of the year, with results due in late 2019.
If it shows efficacy, NT-814 could become an alternative to hormone-based therapies for PMVMS which—while undoubtedly still of value for some women—have fallen out of favor after being linked to an increased risk of breast cancer, heart disease, stroke and blood clots in large epidemiological studies. IHRT is seen as being lower risk in younger women, but safety anxieties remain and there could be big rewards for an effective nonhormonal therapy.
The latest fundraising comes shortly after KaNDy reported phase 1b/2a trial results showing that NT-814 reduced PMVMS by 62% compared to 24% with placebo in the first week of treatment, rising to 84% versus 37% with control in the second week. The company says that puts the drug in the same efficacy range as HRT, but with a considerably faster onset.
“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,” said the biotech’s CEO, Mary Kerr, Ph.D.
KaNDy’s existing backers Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed were joined in the third-round financing by new investor Longitude Capital.
The company is one of a clutch of biotechs focusing on women’s health, an area that has traditionally been underaddressed by the biopharma sector. There are signs of change however, with KaNDy and other companies like Agile Therapeutics, TherapeuticsMD and Evofem Biosciences bringing new therapies through the pipelines, as well as recent IPOs for endometriosis drug developer Myovant and ObsEva, a reproductive health specialist.
The lack of activity in this area has been attributed to the gender gap in biotech company leadership, too few women taking part in clinical trials and a tendency to lump all patients—male and female—into one category. Meanwhile, research suggests that while women make the majority of healthcare decisions for themselves and others, their trust in the industry is low.