Regimen Development

TB Alliance isn’t just developing drugs, but changing the way TB drug development is conducted. New TB multi-drug regimens show promise in offering dramatically faster, simpler, safer, and less toxic therapies that enable global scale-up of treatment, particularly for MDR-TB.

The bacterium that causes TB is remarkably adept at developing resistance to drugs, therefore active TB must be fought with combination therapy. Today’s four-drug first-line TB treatment, which is old and highly inadequate to tackle today’s epidemic, evolved through the addition and substitution of drugs into an existing regimen. To bring a single TB drug through clinical trials takes a minimum of six years, thus the development of a fully novel treatment regimen could take decades. With nearly 2 million people dying from TB yearly, this is absolutely too long to wait.

However, with a substantial global TB drug portfolio and the support of the Critical Path to TB Drug Regimens partners, TB Alliance has introduced a paradigmatic shift in the way TB drug development is conducted. Instead of developing single drugs, one at a time, entire new regimens of drugs are currently being tested together.

Regimen-based development has the potential to save decades of development time, millions of dollars, and precious lives. In 2010, the TB Alliance launched the first-ever TB drug trial testing multiple new compounds in combination, NC-001. Today, multiple novel regimens are under development, showing promise to have a major impact on TB treatment.

TB Alliance also received a grant from the United States Food and Drug Administration to support an initiative, in partnership with Johns Hopkins University, to expand a pre-existing program devoted to testing TB drugs in combination early in the drug development process to identify and advance novel treatment regimens. This initiative seeks to promote regimen-based development by qualifying new preclinical models with better predictability for human disease. These new models could contribute to identifying optimized drug combinations and earlier registration and approval of new, improved, and safe TB drug regimens.

Click here for more information about regimen-based TB drug development