New Biotech KaNDy Therapeutics Launches to Replace Hormonal Menopause Treatment

Published: Sep 27, 2017

New Biotech KaNDy Therapeutics Launches to Replace Hormonal Menopause Treatment September 27, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Stevenage, England – NeRRe Therapeutics spun out a new company, KaNDy Therapeutics, to focus on the development of NT-814 for the treatment of symptoms related to menopause in women.

NeRRe Therapeutics focuses on drugs that target neurotransmitting peptides. KaNDy has a single asset, NT-815. The launch of KaNDy is backed by Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors,who are also investors in NeRRe.

NT-814 is a non-hormonal alternative to hormone replacement therapy. It is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. KaNDy will take the compound into Phase IIb clinical trials for postmenopausal vasomotor symptoms (PMVMS), while also evaluating it for other Women’s Health conditions.

PMVMS affects up to three quarters of peri-menopausal women, the most common of which are hot flashes. Symptoms typically last one to two years after menopause in the majority of women and may last for up to 10 years or longer. About one-fifth of women describe the symptoms as debilitating, severely affecting work and especially sleep.

The compound has been evaluated in a Phase IIa proof of concept study that showed its potential for cutting the frequency and severity of PMVMS.

KaNDy Therapeutics will be led by Mary Kerr, as managing director, and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. Kerr was formerly senior vice president and Global Franchise lead at GlaxoSmithKline . Mike Trower will be KaNDy’s chief science officer and chief operating officer. He was formerly vice president and Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK. And Steve Pawsey will be chief medical officer. He was formerly with Circassia and Vernalis.

“The formation of KaNDy Therapeutics enables us to maximize the potential of NT-814 in a range of debilitating Women’s Health conditions,” Dukes said in a statement. “We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we’re looking forward to advancing this exciting new product into a Phase IIb program.”

The company gets its name from the pathway that NK-1 and NK-3 receptors belong to, the kisspeptin-neurokinin B-dynorphin (KNDy) pathway. The neurons are located in the hypothalamus and control two major pathways involved in menopause. They include the thermoregulatory pathway and the gonadotropin-releasing hormone (GnRH) pathway.

Traditional hormone replacement therapy has largely fallen out of favor due to numerous side effects and an increased risk of heart disease, stroke and breast cancer. In early trials, the drug improved hot flashes, but also helped sleep complications because of its NK-1 component, which has been identified as having sleep benefits.

“For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life,” said Richard Anderson, professor at the University of Edinburgh and a clinical adviser to KaNDy, in a statement. “As a potential once daily alternative to HRT without the issues surrounding hormone replacement NT-814 could bring them considerable relief.”

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