Successful phase 1a study shows YCT-529 is safe
SAN FRANCISCO--(BUSINESS WIRE)--YourChoice Therapeutics, Inc., pioneering hormone-free family planning products, announced today that it has dosed its first cohort of male volunteers with YCT-529 in a phase 1a/2b clinical study. This is the second human study for YCT-529, the only hormone-free birth control pill for men and the only male pill that researchers are testing in humans. YourChoice Therapeutics initiated the study following successful completion of a phase 1a study, which showed the drug candidate was safe for use in men.
“YCT-529 is advancing very efficiently through its human studies,” said Heather Vahdat, executive director of the Male Contraceptive Initiative. “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. A male pill has been 70 years in the making, and today’s news gets us one step closer to realizing this long-held vision.”
September 26 is World Contraception Day, an opportunity to recognize that the last innovation in male birth control was 169 years ago when Charles Goodyear commercialized the modern condom. Today, men have condoms or withdrawal as the only two reversible birth control options. Vasectomy, which is on the rise, is a third option but it’s not easily reversed. Given these options, many men rely on condoms. However, condoms have high failure rates. The latest data show 24 percent of all of abortions are the result of failures associated with condoms. Improved male methods would not only provide more options but potentially impact these data and safeguard women’s health. Guttmacher, which tracks women’s reproductive rights data, shows that 41 states have an abortion ban in place following Roe v. Wade’s reversal in 2022.
“169 years is a long time to wait for innovation,” said YourChoice Therapeutics’ CEO Akash Bakshi. “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 phase 1b/2a study will examine multiple ascending doses (MAD) of YCT-529 in up to 50 male volunteers aged 28-70 to determine tolerability and effect on sperm count. As a retinoic acid receptor-alpha (RAR-alpha) inhibitor, YCT-529 prevents sperm production by blocking access to vitamin A in the testes. Researchers discovered this mechanism of action in the 1930s after discovering that depriving mice, rats, and monkeys of vitamin A caused infertility. Since that time, decades of published studies have validated the pathway.
“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,” said Nadja Mannowetz, chief science officer for YourChoice Therapeutics. “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.”
New Zealand-based NZCR is conducting the study.
About YCT-529
Researchers have understood for decades that vitamin A is essential for male fertility. YCT-529 is a retinoic acid receptor-alpha (RAR-a) inhibitor that prevents production of sperm cells in the testes as well as their release by blocking RAR-alpha (one of three nuclear receptors that bind retinoic acid, a form of vitamin A). YourChoice Therapeutics developed YCT-529 in collaboration with Dr. Gunda Georg, a globally recognized medicinal chemist and awardee of one of the largest NIH-funded Contraceptive Centers. The Male Contraceptive Initiative (MCI) has been committed to funding the early research and YCT-529’s phase one clinical trial in men.
About YourChoice Therapeutics
YourChoice Therapeutics is a clinical-stage biopharmaceutical company developing the first hormone-free birth control pill for men. Based in San Francisco, the company is advancing the only male pill in human studies. Preclinical studies showed YCT-529 performed as effectively or better than the female birth control pill, and a phase 1a study demonstrated safety in humans. Future programs will apply the company’s patented therapeutic platform to develop hormone-free family planning products for women. Established in 2018, the company received a $15M Series A investment in 2022. For more information, visit www.yourchoicetx.com and follow the company on LinkedIn.
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