For two decades, Gunda Georg, regents professor at the University of Minnesota’s College of Pharmacy and founding director of the Institutes for Therapeutics Discovery and Development, has been working on developing a non-hormonal contraceptive for men. In the last year, she and her colleagues have made significant progress on one particularly promising compound: YCT529.
In a highly collaborative project, the preclinical candidate, named in part for Your Choice Therapeutics, a small San Francisco-based startup that licensed the compound from the University of Minnesota, has shown to be successful in a mouse trial, gaining media attention. Your Choice, Georg said, pushed the research even further: “They did studies in monkeys to show it is not only effective in mice — it is also effective in a species that is much closer to humans. This is very exciting.”
Georg said that human trials are on the near horizon. And she’s confident that she’ll have no shortage of study participants. When word of her research’s progress appeared in the national press, she said, “I had all of these men emailing me, wanting to participate in this.”
Georg spoke to me recently from her office on the University of Minnesota’s East Bank. The interview has been edited for length and clarity.
MinnPost: There has been quite a bit of excitement around your research on non-hormonal male contraceptives. Why is that?
Gunda Georg: We had quite a bit of publicity at the beginning of the year. I did an interview in The New York Times. I said, “This is working in mice, but who knows if it will work in humans?” They did a study and YCT529 showed to also be quite effective in monkeys.
My feeling was that I’ve said it before: The world is ready for a male contraceptive agent. We hopefully will be one of the first to bring this contraceptive agent to the clinic. That is why everyone got so excited about it.
MP: Developing this drug will cost a lot of money. How are you raising the funds?
GG: A monkey study costs $400,000. I don’t have that kind of money. A grant from the NIH is $250,000, and you have to share it. That’s why you have to bring in the companies like Your Choice Therapeutics. They have been getting YCT529 ready for a human trial. These are very expensive studies. That’s why we were lucky to find this company to work with us to push this forward.
We have been saying that in this first quarter we will get FDA approval to start with a clinical trial. The Your Choice Therapeutics people have been extremely fast. They’ve raised money, something like $20 million to pay for all of this.
MP: There are other male contraceptives in development. How do they differ from YCT529?
GG: There are already clinical trials under way for male contraceptives, but they are based on hormones, similar to what is being done for women. There have been a lot of side effects. But people have worked on these new drugs that are now in clinical trials. They seem to be much better tolerated. These studies are going on parallel to each other — the hormonal and the non-hormonal contraception.
Some of the men who were in the hormonal trials have experienced depression. Think about that: If you are already depressed and you take something like this that makes it worse that’s not for you. You have to go for something else. That might be ours. My hope is that everything is going to be coming to the market soon. Some men might really tolerate this hormonal contraceptive well and others may not have a good response. There needs to be options.
MP: How does YCT529 work?
GG: Our non-hormonal method is similar to what a hormonal contraceptive does. It reduces sperm count. We reduce sperm count by a different mechanism. What we are doing is we are targeting what’s called a retinoic acid receptor.
This approach goes back to the 1930s, when researchers found that if you deprived mice or rats of vitamin A they become infertile. Then, if you give them vitamin A again, the fertility of the mice and rats is restored. With our method, we are interfering with this vitamin A metabolism which is very important for sperm development. If you mess with that, you just don’t develop the sperm and the count goes down. If you discontinue treatment, your fertility is restored. That was the same as the 1930s study. It is very important that we have reversible agents.
MP: Are men really that interested in a new contraceptive pill? It seems like pregnancy’s repercussions are so much less significant for them.
GG: I think attitudes are changing, because I think there is much more awareness of gender equality. I think particularly the younger generation is really attuned to this. That’s why there is so much interest now. We need options. The world is ready for it. Not everybody. But a lot are.
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