YourChoice Therapeutics Finishes Phase 1a Study for First Hormone-Free Male Birth Control Pill

YourChoice Therapeutics, Inc., a pioneer in hormone-free family planning solutions, has achieved a significant milestone by completing its first-in-human clinical trial for YCT-529, which is poised to become the first hormone-free male birth control pill. The company's CEO, Akash Bakshi, is set to present the results of this phase 1a study at the 2024 BIO International Convention.

Chief Science Officer Nadja Mannowetz expressed optimism about the progress, noting that the initial human trial confirmed YCT-529 is safe and well-tolerated in men. This milestone sets a strong foundation for subsequent studies, moving the company closer to offering a revolutionary birth control solution that could shift the burden of contraception away from women.

Since the introduction of the female birth control pill 65 years ago, innovation in contraception has been minimal. Almost all new contraceptive methods have involved hormonal treatments for women, with the exception of the copper IUD. This has perpetuated the notion that pregnancy prevention is primarily a woman's responsibility. The development of a hormone-free male birth control pill like YCT-529 represents a significant advancement in this field.

During the phase 1a study, researchers administered doses of up to 180 mg of YCT-529 and observed that all doses were safe and well-tolerated. The next phase of research will involve multiple ascending doses (MAD) in a larger group of participants. Previous preclinical studies indicated that YCT-529 is 99% effective and 100% reversible without any side effects.

Stewart McCallum, Chief Medical Officer of YourChoice Therapeutics, highlighted the stagnation in birth control innovation, noting that the success of YCT-529's phase 1a study marks a crucial step towards providing new contraceptive options for men. He emphasized that the introduction of a hormone-free male pill would benefit both men and women, reducing the hormonal burden currently placed on female partners.

YCT-529 works by inhibiting the retinoic acid receptor-alpha (RAR-alpha), a mechanism that blocks sperm production by preventing vitamin A from reaching the testes. This method of action was first discovered in the 1930s when researchers found that vitamin A deprivation caused infertility in mice, rats, and monkeys. Decades of research have since validated this pathway.

Gunda Georg, a leading medicinal chemist and developer of YCT-529, affirmed the necessity for male contraceptives, particularly in the context of women’s reproductive rights. She lauded the efficiency and speed of the first-in-human study and expressed confidence in the success of future trials. Georg emphasized that society is ready for a male contraceptive and commended the organizations supporting this groundbreaking work.

The phase 1a study of YCT-529, initiated in December 2024, was conducted by Quotient Sciences in the UK. This research builds on a longstanding understanding of the critical role vitamin A plays in male fertility. YCT-529’s inhibition of RAR-alpha effectively prevents sperm production and release, with preclinical studies demonstrating a 99% success rate in preventing pregnancies in mice and complete reversibility.

YourChoice Therapeutics, established in 2018 and headquartered in San Francisco, is currently the only company conducting human trials for a male birth control pill. The company aims to leverage its patented therapeutic platform to develop additional hormone-free family planning products, including options for women. In 2022, YourChoice Therapeutics secured a $15 million Series A investment to further its research and development efforts.