YourChoice Therapeutics, Inc., pioneering hormone-free family planning products, announced today that Communications Medicine, a Nature Portfolio journal, has published a peer-reviewed paper on the discovery of YCT-529, a new chemical entity that is a retinoic acid receptor-alpha antagonist. YCT-529 is designed to be a first-in-class, hormone-free, orally administered male contraceptive. The manuscript, “Targeting the Retinoid Signaling Pathway with YCT-529 for Effective, Reversible Oral Contraception in Mice and Primates,” describes the data that identified the novel target for male contraception and established YCT-529’s suitability for human studies.
The paper shows YCT-529 causes infertility in mice after four weeks of oral administration and is fully reversible within six weeks after dosing ends. Additional data show that in non-human primates, YCT-529 inhibits sperm production within two weeks of oral dosing. Within 10-15 weeks after dosing ends, sperm counts fully reversed. Researchers detected no side effects in either group.
“There's a unique demand for contraceptives that are hormone-free,” said Nadja Mannowetz, lead author, chief science officer and co-founder of YourChoice Therapeutics. “This first published study for our hormone-free male birth control pill candidate details the groundwork for discovering and then evaluating YCT-529 in human clinical trials, which are progressing efficiently. With an unintentional pregnancy rate at nearly 50 percent in the U.S. and globally, we need more contraceptive options, particularly for men who have only condoms and vasectomy. We’re very pleased to be advancing a new generation of male contraceptives and are grateful to Communications Medicine for publishing our research.”
YCT-529 prevents sperm production by interfering with vitamin A metabolism in the testes. Specifically, YCT-529 inhibits binding of retinoic acid - a metabolite of vitamin A - to retinoic acid receptor-alpha, a well-known pathway needed for sperm cell production that nearly 100 years of research has validated. Researchers are currently studying YCT-529 in a phase 1b/2a clinical study that will evaluate multiple ascending doses (MAD) of the once-daily oral pill in up to 50 participants to assess safety, tolerability, and effect on sperm count.
“Nature publications are among the world’s most prestigious science journals,” said Akash Bakshi, CEO of YourChoice Therapeutics. “As the first hormone-free male pill candidate, YCT-529 is a trailblazer. We made history when we completed the first human study of a hormone-free contraceptive pill in June 2024. A Nature publication in quick succession offers powerful validation that we can build upon with our second human study, which is currently underway and progressing well.”
There is a critical need for new male contraceptives. 80% of men feel sole or shared responsibility for pregnancy prevention. Yet, their contraceptive options are limited to condoms and vasectomy and studies continue to show condom use is declining. Data also show men and their female partners are eager to use new male contraceptives: a recent study demonstrates high demand for novel male contraceptive options and female partners’ trust in men to use them. The Communications Medicine study validates YCT-529 as a promising male contraceptive candidate that’s appropriate for further clinical testing. YourChoice Therapeutics completed a successful phase 1a study for YCT-529 in June 2024 and is currently evaluating safety and efficacy in a phase 1b/2a human study.
About YCT-529
YCT-529 is a first-in-class, new chemical entity acting as a retinoic acid receptor-alpha (RAR-a) inhibitor that is designed to prevent production of sperm cells in the testes as well as their release. YourChoice Therapeutics is currently assessing safety and efficacy of YCT-529 in a phase 1b/2a clinical trial in New Zealand as the first non-hormonal, oral male contraceptive. 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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