(CN) — Scientists from the University of Minnesota presented research to the American Chemical Society on Wednesday regarding a new non-hormonal pill for men that could result in a sea-change in contraception.
A study of the drug in mice showed it dramatically reduced sperm counts and was 99% effective in preventing pregnancy. The researchers did not observe any side effects and the mice regained the ability to reproduce four to six weeks after they stopped taking the compound.
Unlike other contraceptives for men that target hormones like testosterone, the researchers focused on targeting proteins essential to the production or mobility of sperm cells. During this process, they identified a compound that targets a protein vital to cell growth, sperm formation and embryonic development.
Abdullah Al Noman, a graduate student from the lab of Medicinal Chemistry Department Head Gunda Georg, said previous hormonal contraception for men has largely stalled because the hormone changes can spur side effects including depression and risks of cardiovascular disease. Further, most of the hormonal contraceptives for men must be injected. Noman said the development of the pill they administered to the mice orally could prove transformative due to its convenience and effectiveness.
“It has a widespread public health implication because half of the world population could be the potential consumer of this pill that we discovered,” Noman said, noting the “revolution in terms of family planning and sexual health” that came with the development of the first birth control pills for women over 60 years ago.
The effectiveness of the drug in preventing pregnancy in the mice without rendering them permanently infertile or causing adverse side effects gives the research team hope for the pill’s success in humans.
“Mice are much more fertile than humans, so we hope that we see similar or better effects in humans,” Noman said. Noman added that the compound worked as effective contraception when the mice received a dose of 10 milligrams per kilogram of their mass and noted that the mice received as much as 1,000 milligrams per kilogram of mass and did not die.
“This tells us that we have a really high safety profile for this compound, at least in mice,” Noman said.
The researchers licensed the compound to YourChoice Therapeutics, which is gathering and reviewing the researchers’ data to present to the Food and Drug Administration in order to get the green light for human clinical trials.
“In an academic center, we can only take things so far and then it becomes rather expensive, and that’s where companies come in,” said Georg. “They’re determining the maximum tolerated dose in rats and dogs. That’s the next step, the next hurdle that has to be overcome to get to a clinical trial. “
The research team expects human clinical trials to begin before the end of 2022. Georg added that making the drug substance is underway. She said that while side effects may emerge when a wider population takes the drug, they are optimistic.
“Unless something major happens, which is of course always a possibility in drug discovery, we’re very, very hopeful that this is going forward into the clinic,” Georg said. “That’s why we’re pretty excited about it because it would be the first ever non-hormonal agent to go to the clinic. We have a lot of studies that show men, women, couples would actually be quite pleased to have other methods to use.”
In the meantime, Georg and Noman said they are continuing tests to find the most potent compound possible so that they can use the smallest dose to the greatest effect. Noman credited the funding from the National Institutes of Health and the Male Contraceptive Initiative for recognizing the room for research on contraception for men.
“Male fertility is not a really well-explored discipline,” Noman said. “I feel like if there is more support, more researchers would be interested in this discipline. Somebody once said it takes a village to make a drug.”