FDA Commissioner Margaret Hamburg announced, on Thursday, a new joint initiative between industry, FDA, and non-profit organizations designed to fast-track modern combination treatments for tuberculosis. Where once it took more than two decades to create new therapies for TB, this collaboration is expected to produce working treatments in less than six years, providing much-needed help for people developing nations.
Dubbed the Critical Path to TB Drug Regimens, this program will enable different stakeholders to share new compounds and ideas in an effort to shorten the time it takes to develop new multi-drug therapies. The initiative is spearheaded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the Global Alliance for TB Drug Development, with partners including members of FDA, the World Health Organization, Johnson & Johnson, Sanofi-Aventis, and Pfizer.
“FDA is absolutely committed to working with industry and other partners to speed access to new, safe, and highly-effective treatments for TB, which continues to mutate and spread,” stated Hamburg in a release. “I’ve seen first-hand the public health impact and personal tragedy of drug-resistant TB. This creative approach mirrors FDA’s own investments in innovative regulatory science that ensures the best new medical technologies—including combination therapies—reach patients as soon as possible.”
According to TB Alliance President and CEO Mel Spigelman, the catalyst for this collaboration was a critical mass of raw materials or substrate in the pharma pipeline.
“The real issue for TB has been that it’s a truly neglected disease, and until not that long ago no one was working on new drugs even though there was a clear need for it,” Spigelman said in an interview with Pharm Exec. “We presented this idea five years ago, but there simply weren’t enough compounds to work with.”
There are now nine compounds in clinical development for TB. This critical path is intended to get one or more new regiments registered and adopted as soon as possible.
What makes TB drug development so complicated is that treating the disease with a single drug almost always leads to treatment resistance (sometimes within as little as two weeks). While patients might feel better in the short term, the disease never really goes away. To completely defeat the TB, patients must be treated with a regimen of multiple drugs or a drug cocktail.
Traditionally, a company looking to add new drugs to a treatment regimen would have to spend a minimum of six years in testing. A Phase III study alone could take four years to show results. A pharma company trying to develop a cocktail of four treatments could feasibly spend up to 25 years testing each drug.
“Whether the combination happens to have one new drug in it or four new drugs, you are really testing that combination once you get beyond two weeks,” Spigelman said.
About two years ago, the TB Alliance began reaching out to different partners for research purposes and to look at combination of different drugs in animal models. The organization formed bilateral agreements with multiple sponsors and brought them into the initiative one by one to work with academic collaborators on testing preclinical combinations.
“We’ve already identified, in mice, at least 10 different regimens that look much better than the standard treatment,” Spigelman said. “That’s a building block that helps forge the pathway in the clinic.”
This type of approach could also be translated to other diseases such as malaria. HIV had a similar critical path in the 1990s, when a number of pharma companies share d knowledge as a springboard to get combinations developed more quickly.