Along with advances in treatment, tuberculosis research continues to advance apace. So swiftly that sweeping data integration and clinical trial simulations are needed to help decide which targets on the discovery horizon to prioritize and how to go about constructing wholly novel treatment regimens.
That’s why, in late March, the National Institutes of Health launched the Preclinical Design and Clinical Translation of TB Regimens (PReDicTR) Consortium.
Kelly Dooley, MD, PhD, MPH, the Addison B. Scoville, Jr. Professor of Medicine and director of the Division of Infectious Diseases and at Vanderbilt University Medical Center, is one of four co-principal investigators for the five-year multicenter project.
“With the large number of new compounds in the development pipeline for TB treatment and the increasing volume of data emerging from preclinical experiments and clinical trials, the NIH and the new consortium have identified a pressing need for greater collaboration, coordination and innovation to steer translational research in TB,” said Dooley, professor of Medicine and Pathology, Microbiology and Immunology. “In stimulating collaboration among TB research grantors, data scientists, drug developers, basic scientists, pharmacometricians, and clinical trialists, PReDicTR stands to speed the development and delivery of more effective and potentially simpler and safer drug regimens for patients with TB everywhere.”
The $31 million grant (a UM1 cooperative agreement) was awarded to Rada Savic, PhD, co-vice dean of graduate pharmacy education and professor in the department of bioengineering and therapeutic sciences at the University of California, San Francisco.
The project will seek to refine and validate preclinical models for TB drug testing; develop new methodologies to combine preclinical and early clinical data; and create a framework for model-informed decision-making in TB drug development.
“The way to an improved road map is increasingly clear,” Dooley said. “By integrating preclinical and early clinical data — and we have a ton of this already in hand — we can use translational modeling to help streamline animal model experiments and perform clinical trial simulations that help us to make more accurate predictions about which drug combinations are most likely to succeed in later-stage trials. New collaboration around these research design principles can accelerate the delivery of new treatments to the patients who need them most.”
The World Health Organization estimates that, in 2022, 10.6 million people became ill with tuberculosis and 1.3 million died of TB disease. TB is the second leading cause of death by an infectious disease, after coronavirus disease, and resistance to existing TB drugs is on the rise.
The consortium’s remaining two co-principal investigators are Eric Nuermberger, MD, of Johns Hopkins University, and Dirk Schnappinger, PhD, of Weill Cornell Medicine. Other participating centers include Colorado State University, University of Colorado Denver, Tufts College, The Rockefeller University, Stellenbosch University, Leiden University, The Global Alliance for TB Drug Development Inc., and HMH Hospitals Corporation.
PReDicTR is funded by NIH grant UM1AI179699.
