YourChoice Therapeutics, a San Francisco-based biopharmaceutical company, has announced the commencement of its second human study for YCT-529, a hormone-free male birth control pill. The company has dosed its first cohort of male volunteers in a phase 1b/2a clinical study, following the successful completion of a phase 1a study that demonstrated the drug candidate’s safety for use in men.
The phase 1b/2a study will examine multiple ascending doses of YCT-529 in up to 50 male volunteers aged 28-70. The study aims to determine the drug’s tolerability and its effect on sperm count. YCT-529 functions as a retinoic acid receptor-alpha (RAR-alpha) inhibitor, preventing sperm production by blocking access to vitamin A in the testes.
Heather Vahdat, executive director of the Male Contraceptive Initiative, said: “YCT-529 is advancing very efficiently through its human studies. YourChoice Therapeutics’ early successes buoy the path for the wave of emerging male birth control options in earlier stages of development. We feel confident in YCT-529’s continued success, and we’re proud to be a funding partner for a hormone-free male birth control pill.”
Akash Bakshi, CEO of YourChoice Therapeutics, said: “169 years is a long time to wait for innovation. I can’t think of another area of medicine where innovation has stalled for nearly two centuries. We need more male methods, and we need them quickly. We anticipate another efficient trial and hope to announce results in 2025.”
The development of YCT-529 builds on decades of research into the role of vitamin A in male fertility. The mechanism of action was first discovered in the 1930s when researchers found that depriving mice, rats, and monkeys of vitamin A caused infertility. Since then, numerous published studies have validated this pathway.
Nadja Mannowetz, chief science officer for YourChoice Therapeutics, emphasized the broader implications of this development: “A new birth control option for men would not only offer a shot of innovation to a very deserving healthcare segment, but also improve women’s health as reproductive rights and even access to contraceptives are at risk. Women have shouldered the burden of pregnancy prevention for too long. Data continue to show that men want to help, and they’re willing to try new birth control options. Data also shows women trust them to do so.”
YourChoice Therapeutics developed YCT-529 in collaboration with Dr. Gunda Georg, a globally recognized medicinal chemist. The company, established in 2018, received a $15M Series A investment in 2022. The current study is being conducted by New Zealand-based NZCR.
