YCT-529, a Male Birth Control Pill, Enters Clinical Trials

YourChoice Therapeutics announced on Dec. 13 that it had entered phase one of its clinical study for the first hormone-free male birth control pill. Currently, reversible options for male birth control are limited.

In initial pre-clinical trials funded by the National Institutes of Health, the non-hormonal male birth control called YCT-529 proved to be 99% effective and 100% reversible with no side effects.

CEO, Akash Bakshi, tells Healthnews his company’s hormone-free birth control pill has been in motion since 2018. The product works by decreasing sperm concentrations so men can still ejaculate but no sperm is released, meaning sperm possibility goes to zero.

The need for male birth control

According to the Male Contraceptive Initiative 2019 survey, 70% of men say they are very or somewhat interested in male contraception. A majority of those men say they prefer a norn-hormonal method to a hormonal one. Also, 60% of those men felt the responsibility of birth control rested on their shoulders. Bakshi notes this has become an increasing phenomenon since the turn of the century.

"The data shows that demand for male contraceptives from men increased in the 2000s, and paternity tests became possible," Bakshi says. "Before that, what would happen, a woman would say she got pregnant and say you are the father and the man would say no it wasn’t me. Now there is a paternity test that states who the father is and he is responsible for paying child support. Now we see there is a demand from men to prevent such unplanned pregnancy."

Additionally, Bakshi hopes YCT-529 can relieve some of the pressure that surrounds women in family planning. He believes abortions are an interesting case to evaluate and points to a report from the Guttmacher Insititute that found women looking to prevent pregnancies with contraceptives still became pregnant. The study found over 50% of women who seek an abortion are doing so because a contraceptive method failed them.

"That means 50% of women were trying to do the right thing to prevent unplanned pregnancies and yet the failure rate of the contraceptive resulted in them having an unplanned pregnancy they sought to terminate," Bakshi says.

Over 500,000 men each year undergo a vasectomy. Vacestomies are available as birth control options, however, in most cases, the surgery that cuts the supply of sperm to your semen is irreversible. Bakshi says the most common form of irreversible birth control in men is condoms, which in many cases, are ineffective. The U.S. Centers for Disease Control and Prevention lists the typical use failure rate for condoms as 13%.

How YCT-529 works

YourChoice Theraputics’s YCT-529 non-hormonally inhibits spermatogenesis, the development of sperm cells within male reproductive organs. YCT-529 does this by blocking the target retinoic acid receptor-alpha (RAR-a), which is required for spermatogenesis. Pre-clinical trials found the drug 100% effective in mice, rats, dogs, and non-human primates with zero side effects.

Bakshi envisions the drug will be taken daily by humans, and within two to four weeks, a man will become temporarily infertile. The exact timeframe will become more clear during clinical trials. As for reversing the effects, Bakshi says that depends on sperm production, which is longer than two to four weeks.

The return in fertility is based on how long it takes to produce sperm. Spermatogenesis in humans takes around 72 days, and we envision that it would take two cycles of that to get your sperm counts back to normal. We see a benefit here in that we envision that the delay in return in fertility is a belt-and-suspenders approach in the offset chance that men are not 100% compliant in taking the pill every day.

- Bakshi

Bakshi expects the three-phase clinical trial process to last up to 10 years. He is hopeful that the pill will be covered by insurance. The Affordable Care Act requires most insurance plans to offer birth control with no out-of-pocket cost. The U.S. Centers for Medicare and Medicaid service says the measure has provided millions of women with birth control coverage. In the future, it may be up to legislators to decide if male birth control pills hold the same weight.

YCT-529 is YourChoice’s main mission, but Bakshi notes the company is currently working on non-hormonal contraceptives for women and non-hormonal fertility enhancements based on sperm parameters. He has high hopes that YCT-529 will succeed in its clinical trials with few drawbacks.

"It is hard to state, but I had always thought the hardest part of this process was the development of a molecule that would be an effective male contraceptive," he says. "I think we now have a product that is safe and looks like it is effective. I am excited to see what happens next."