The Critical Path Institute, an independent nonprofit that catalyzes innovative ideas to accelerate the speed of drug and medical product development, has received a three-year grant from the Bill & Melinda Gates Foundation. The grant will be used to develop quantitative mathematical models to optimize the design of clinical trials and tackle challenges facing the development of effective tuberculosis (TB) treatments.
The grant work, which is focused on advancing the science behind TB drug treatments, will be implemented through the Critical Path to TB Drug Regimens Initiative (CPTR). Co-founded by the Critical Path Institute, the Bill & Melinda Gates Foundation and the Global Alliance for TB Drug Development, the CPTR initiative has multiple, related projects. These include developing physiologically-based pharmacokinetic models, which enable improved understanding of the absorption and distribution of TB drugs through the lungs, and a population-based pharmacodynamic model to help determine effective treatment doses. Additionally, the project will enable promising drug combinations to be tested and developed together to create entirely new multi-drug treatments.
"TB is a pressing global public health issue and stopping its spread requires new treatment options," said Martha Brumfield, Ph.D, president and CEO of the Critical Path Institute. "This grant and the collaborative work of CPTR will reduce the time and uncertainty in developing innovative regimens from decades to years."
TB is a disease caused by Mycobacterium tuberculosis, a bacterium that attacks the body, most frequently the lungs, kidney, spine or brain. According to the Centers for Disease Control and Prevention, a total of 9,945 TB cases were reported in the U.S. in 2012. Worldwide, TB remains a major global health problem, particularly in developing countries. In 2012, an estimated 8.6 million people developed TB and the World Health Organization reported 1.3 million fatalities. India has two to three million people with TB infections, helping to prompt the United Nations to incorporate "halting and reversing the TB epidemic by 2015" as one of its Millennium Development Goals.
To support the CPTR project, Janssen R&D, a subsidiary of Johnson & Johnson, will provide data from its clinical trials of Sirturo (bedaquiline) to CPTR's Regulatory Science Consortium. The approval of Sirturo in 2012 ended a 50-year drought in new treatment options for TB, widely acknowledged as a neglected disease. CPTR's Regulatory Science Consortium is focused on developing and integrating data standards, developing quantitative disease progression and response metrics, as well as facilitating new pharmacokinetic measures for drug interactions.
A significant portion of the efforts to expedite availability of TB treatments is advancing understanding and decreasing risk and failure often associated with late stage clinical trials for TB. CPTR's unprecedented collaboration with pharmaceutical companies and strong commitments from public and private partners around the world are enabling the design of models that make clinical trials for TB more efficient and speed development of TB treatments from early clinical testing.