1 Building a more physiologically-relevant lung model As part of this mission, the Regulatory Science Consortium for the Critical Path to TB Drug Regimens (CPTR) Initiative, led by the Critical Path Institute, coordinates collaborations to develop quantitative platforms to revamp drug development. The CPTR Initiative is a cross-sector initiative to develop novel approaches to expedite new, safe, and effective TB treatment regimens with shorter therapy durations. In this blog post, I’ll discuss our work with the Critical Path to TB Drug Regimens (CPTR) Initiative to develop new modeling and simulation tools to help drug developers combat TB. These challenges with current anti-TB therapy have led to attempts to improve TB treatment regimens and to develop novel anti-TB drugs.
In addition, strains of mycobacterium tuberculosis resistant to the standard of care drugs have begun to emerge. Most TB drugs are more than 40 years old, have significant side effects and drug interactions, and require long treatment periods (treatment courses usually last for at least 6 months). The lack of correlation between the administered dose and the drug concentration in the plasma, lung, and granulomas is thought to contribute to the need for long treatment durations and also to the failure of novel drug regimens. To effectively treat TB infections, drugs have to move from the site of administration (usually the intestine following oral administration) into the blood stream and from there they need to effectively distribute into the lung tissue and attain sufficient concentrations within the granuloma to kill the mycobacteria. A hallmark of pulmonary TB is the formation of mycobacteria containing granulomas-heterogeneous lesions composed of a macrophage- and neutrophil-rich cellular rim surrounding a necrotic core.
TB usually attacks the lungs but can infect any part of the body. TB is also the leading cause of death in HIV-infected individuals. Tuberculosis (TB)-caused by infection with the mycobacterium Mycobacterium tuberculosis-is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015.
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