YourChoice Therapeutics has commenced a Phase Ia/IIb clinical trial of YCT-529, a novel hormone-free male contraceptive pill. The trial, conducted by New Zealand-based NZCR, aims to assess the drug's tolerability and its effect on sperm count in male volunteers. This development addresses a long-standing gap in contraceptive options, potentially shifting the burden of pregnancy prevention more equitably.
The Phase Ia/IIb trial will enroll up to 50 men between 28 and 70 years old. Participants will receive multiple ascending doses of YCT-529 to determine the optimal dosage and evaluate potential side effects. The primary endpoint is to assess the drug's safety and tolerability, while secondary endpoints include evaluating the impact on sperm count and hormone levels.
YCT-529 functions as a retinoic acid receptor-alpha (RAR-alpha) inhibitor. This mechanism blocks access to vitamin A in the testes, which is essential for sperm production. Research dating back to the 1930s has validated this approach, with animal studies demonstrating infertility induced by vitamin A deprivation.
Nadja Mannowetz, chief science officer at YourChoice Therapeutics, emphasized the importance of this innovation, stating, "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. After nearly two centuries of no innovation in male birth control, it’s time for change, and we’re pleased to be a part of it."
Preclinical studies have indicated that YCT-529's effectiveness is comparable to, or even surpasses, that of traditional female birth control pills. YourChoice Therapeutics, established in 2018, is focused on creating innovative contraceptive solutions, supported by a $15 million Series A investment in 2022.
Akash Bakshi, CEO of YourChoice Therapeutics, highlighted the stagnation in male contraceptive development, noting, "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."
