Hormone-Free: YourChoice's Male Birth Control Safe So Far

For decades, women have predominantly been responsible for birth control, but recent developments may soon offer men a viable, hormone-free alternative. YourChoice Therapeutics introduced YCT-529, a non-hormonal contraceptive for men, at the BIO International Conference in San Diego on June 4. Preliminary phase 1a data from studies on 16 participants suggested that the drug is safe and might permit dosing intervals of up to two weeks, addressing concerns that men might be reluctant to adhere to a daily pill regimen.

Akash Bakshi, co-founder of YourChoice Therapeutics, noted that the extended half-life of YCT-529 could enhance compliance, ultimately benefiting women's health and well-being by sharing the responsibility of birth control. Bakshi, along with co-founder Nadja Mannowetz, Ph.D., established YourChoice in 2018 to develop hormone-free contraceptives for women. They initially licensed niclosamide, an antiviral drug from the University of Minnesota, but shifted its focus to COVID-19 treatment under ANA Therapeutics during the pandemic, attracting significant investor interest. Despite the success of ANA Therapeutics, Bakshi and Mannowetz returned to their original mission, pivoting to a non-hormonal, reversible oral contraceptive for men, developed by University of Minnesota scientist Gunda Georg, Ph.D.

The male contraceptive field has seen notable advancements recently, partly due to support from institutions like the National Institutes of Health's Contraceptive Development Program and nonprofits such as the Male Contraceptive Initiative. Just before YourChoice's presentation, researchers from the Population Council shared promising results for Nesterone, a hormone-based male birth control gel, in a phase 2 trial involving 222 subjects. Nesterone operates by reducing sperm production through testosterone level alteration—a method that, while effective, has encountered adverse effects in past trials.

In contrast, YCT-529 functions without influencing hormones. It inhibits retinoic acid receptors in the testes that are crucial for sperm production, potentially reducing side effects. Bakshi emphasized the need for diverse birth control options for men, suggesting that large-scale clinical trials are required to fully understand the advantages of hormone-free versus hormone-based contraceptives.

While it remains uncertain whether YCT-529 will be effective in humans, preclinical tests on mice, dogs, and primates demonstrated that the drug is safe, up to 99% effective, and reversible. YourChoice is preparing for a phase 1b trial to evaluate the safety and pharmacokinetics of multiple doses, aiming to complete it by early 2025. With sufficient funding to continue through 2026, YourChoice plans to progress YCT-529 through early safety and efficacy trials, backed by a $15 million Series A funding round led by Future Ventures. The company also intends to commercialize the drug, potentially reviving their initial goal of a non-hormonal contraceptive for women.

Bakshi believes that introducing male contraception could reshape the contraceptive market and spark interest in non-hormonal birth control options for women. He hopes this development will raise the question of why a non-hormonal pill for women has not yet been made available if men can access one first.

In conclusion, the ongoing research and potential of YCT-529 highlight a significant shift in the contraceptive landscape, promising broader, more equitable birth control options.

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