We’ve repeatedly given the same response for why a male contraceptive hasn’t reached the market. There needs to be more funding available, and it needs to be funding for the right kind of research.
That’s why we’re stepping up.
Following the generous support of an anonymous donor, we’re announcing a request for proposals. We’re providing up to half a million dollars in research funding to at least one recipient.
This funding will help to fill a crucial hole in the development process—particularly work before human clinical trials. This is where traditional funders perceive a high risk. And it is high risk. This stage of research is so difficult to get through that the pharmaceutical industry calls it the “valley of death”.
Here’s why it gets the name.
It’s hard to come up with a version of the drug—called a lead compound—that’ll go on to be used in human clinical trials and (with hope) to market. To address this, researchers use a number of tools to analyze endless iterations of a potential drug.
Researchers have to cross their fingers that their drug will have a number of properties. For starters, the body has to be able to absorb it (bioavailability), it has to be able to last long enough to be useful (have a good half-life), it has to have a strong buffer between its effective dosage and where it would be toxic, it has to have specific targeting in how it works to avoid side effects, and it actually has to work using an animal model.
Our funding is allowing researchers to test all this. We’re also doing something a little different in that we’re restricting funding to certain kinds of male contraceptive research.
Here’s the breakdown:
- It can’t be hormonal.
There’s no need to play the game of which sex can experience more side effects. Male contraceptive research is already going on in this hormonal area, as we’ve spoken about before. And that research may eventually be successful. From our perspective, however, it’s a rougher road than is necessary.
- It can’t stop sperm production.
There are a host of issues here. There’s the risk that sperm production doesn’t return. (This has occurred before.) There’s the months-long delay before effectiveness occurs since all the existing sperm don’t suddenly vanish from the body. Finally, there’s the issue that men would have to monitor their sperm count. That could mean regularly going to getting it checked or using a home kit. Typically, the more you demand from a user, the more you can expect unplanned pregnancies to occur in the real world. Not what we want.
- It can’t use immunological approaches.
Just as with hormonal methods, we want to avoid approaches that are prone to unwanted side effects and unpredictable duration of action. Earlier research here showed that you can immunize animals against sperm. But each animal’s immune system is a little different. This means that for some men, the contraceptive effect might last 3 months, for others 6 months, and for others forever. That’s too unpredictable.
- It can’t focus on the early part of sperm development .
We want to avoid risks of any potential changes in sperm that could cause a genetic abnormality should a pregnancy occur. During early sperm development, the genes are getting reshuffled and rearranged. Theoretically, this might increase the chance of some sperm getting through that had genetic problems. Also, affecting the early stages of sperm production means that it would take months before the drug was effective—similar to stopping sperm production. Too many avoidable risks here.
So what’s left?
A lot. We’re still open to interfering with late-stage sperm maturation. This means we don’t have a long wait for effectiveness and we avoid the issue of sperm with bad genes getting through.
Sperm function is still an option as well. Some examples might include sperm not being able to swim properly or being unable to fertilize an egg. Again, we’re hitting approaches that can act quickly.
There’s also sperm transport. If there’s a way to keep sperm from expelling from the urethra, that also works. It meets all of our guidelines as well.
These three approaches likely cover most of what’s possible. But if there are other approaches that meet our criteria, we’ll be excited to see them.
Additionally, one of our other projects this year is a consumer research acceptability study. This data will help to guide us as we learn what men really want in a contraceptive. We’ll look forward to sharing this as well.
We hope that making this grant (or grants) will bring us closer to a male contraceptive as well as to inspire future funding. We look forward to seeing some amazing science and sharing our decision with all of you.
You can find the full details of the request for proposal here: www.malecontraceptive.org/2017RFP
Press Release: https://www.malecontraceptive.org/pr2017rfp/