YourChoice Therapeutics has commenced the dosing of subjects in a Phase I clinical trial of YCT-529 for its potential as a hormone-free birth control pill in men.
UK’s Quotient Sciences is conducting the trial, which will evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics of single ascending doses of the drug candidate administered orally in 16 male volunteers.
YCT-529 is an inhibitor of retinoic acid receptor-alpha (RAR-alpha). It works by preventing the production of sperm in the testes by hindering access to vitamin A, an established pathway linked to fertility.
It also inhibits the release of sperm cells by hindering RAR-alpha, a nuclear receptor that attaches to retinoic acid, a kind of vitamin A.
According to data from the US National Institutes of Health (NIH)-funded preliminary preclinical research, YCT-529 was demonstrated to be 99% effective and fully reversible without any side effects.
The Male Contraceptive Initiative (MCI) is supporting the initial research and the Phase I trial of YCT-529 in men.
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YourChoice Therapeutics co-founder and CEO Akash Bakshi said: “YCT-529 blocks a protein, not hormones, to prevent sperm production.
“We believe this will be more attractive to men, most of whom view pregnancy prevention as a shared responsibility even despite today’s limited contraceptive options, which are permanent or only moderately effective.”
Existing drug candidates in clinical development utilise hormonal agents to suppress testosterone to prevent the production of sperm. But the testosterone suppression might not fully prevent sperm production.
Furthermore, such an approach is associated with severe side effects such as high cardiovascular disease risk, weight gain and decreased libido, among others.
YCT-529 was developed by YourChoice in partnership with the University of Minnesota College of Pharmacy regents professor and Institutes for Therapeutics Discovery and Development founding director Dr Gunda Georg.
Georg said: “Our preclinical data is strong, showing that YCT-529 was 99% effective in preventing mouse pregnancies and decreasing monkey sperm counts after two weeks of dosing.
“YCT-529 has also demonstrated a strong safety profile, and full reversibility in mice and monkeys once treatment ended.”