One of my most embarrassing talking points on tuberculosis is that there have been no new first-line treatments for TB since before we put a man on the moon. This is a ridiculous amount of time to not have new, widely used treatments for a disease that kills 1.8 million people each year.
We just took an important step closer to making that statement untrue.
Tuberculosis drug development is slow, expensive, and there isn’t a good market for TB drugs because most of the people who get sick are poor. As it stands, it is in some ways a minor miracle that we’ve gotten even a tiny handful of new drugs over the last few years – bedaquiline, delamanid, and linezolid – but all of these are for use in second-line treatments only. This means only people with drug-resistant TB are given the new drugs.
But even these new drugs have problems. TB is a tough little bug. When you’re treating it, you never use just one drug in case the bacteria develop a resistance to it. So you always use a combination or drugs, called a ‘regimen’. This is great because it hits the TB with a powerful, multi-pronged attack, but it’s bad news for developing new drugs.
Why? Because single new drugs are often tested by themselves first by individual companies to make sure they work, and only then are they tested in combination with other drugs. This not only takes time (a TB drug trial can take years) but adds cost, complexity, and, critically, it means that the various intellectual property holders of all the drugs involved in the combination regimen have to come together and figure out how the licensing and royalties will work so they can all get paid.
As you can imagine, this is a complex negotiation. And all that negotiation and subsequent work for very little reward? That’s a perfect recipe for market failure, and no new drugs.
This is why this news is so exciting! To help solve the problem of building drug regimens, and to help ensure possible new drugs can be tested and sold affordably, we have an organisation called the Medicines Patent Pool. Originally just for new HIV drugs, the Pool has recently been told to work on TB, too.
The Medicines Patent Pool (MPP) works with drug developers to collect the licenses for the intellectual property of lots of drugs into a pool. Then, they can licence rights to use these drugs to any organisation proposing to hold regimen trials, often in return for a reasonable, negotiated royalty to the original drug-developer. This then allows for easier testing of potential drugs in combination, pulling down the barriers to the development of the new TB regimen we all desperately want and need. This is a smart solution to a complex problem.
To ensure people who need the drug can access it and health systems can afford it, any product resulting from licences coming from the Pool has to be affordable – it’s part of the deal. They have to also be produced to the highest standards and be careful how any new drugs are used so that resistance does not develop – called ‘stewardship’.
On the 25th of January, the Medicines Patent Pool have landed their first potential TB drug, Sutezolid, and alongside Johns Hopkins University, are proudly letting the world know that it is available for use by researchers and product development organisations that want to use it to develop new combination TB treatments.
This is huge news. Sutezolid is made available under a worldwide, royalty-free license, so anyone can use it and is a potentially important component of any new TB regimens. What’s even more exciting about Sutezolid is that any regimen containing it could potentially be used to effectively treat both drug-sensitive and drug-resistant TB.
It’s not every day you get a promising new lead in the arms race against TB. While a new combination drug regimen to fight TB that includes Sutelozid likely remains years away, we just took a crucial step forward, and I’d like to offer my congratulations to everyone who has worked hard to make this happen.