Photo: Faith Ninivaggi
A UMass Chan Medical School pulmonology and biomedical research expert is helping lead a nationwide clinical study funded by the Department of Defense (DOD) targeting idiopathic pulmonary fibrosis.
Fernando Martinez, MD, the Joseph D. Early Chair in Biomedical Research, professor of medicine, vice chair for clinical and translational research and academic chief of the Division of Pulmonary, Allergy and Critical Care, is the principal investigator on a DOD-funded consortium project repurposing metformin, a drug commonly used to control sugar levels in people with Type 2 diabetes, to treat patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive disease impacting the lungs.
Idiopathic pulmonary fibrosis is considered a rare disease, with more than 80,000 people in the U.S. affected and more than 25,000 new cases diagnosed each year. Patients with the disease have a median survival of three to five years after diagnosis, according to the U.S. Centers for Disease Control and Prevention.
The project aims to address the effectiveness of metformin in IPF using a multicenter approach. The study will integrate approximately 55 Pulmonary Fibrosis Foundation (PFF) care centers and Veterans Affairs (VA) Medical Centers across the country. It will also define the ability of a newly developed blood test that may be able to identify patients suffering from IPF who are at increased risk for adverse outcomes.
“It’s safe to say that pulmonary fibrosis is of interest to the DOD because epidemiological data have demonstrated that veterans are at increased risk for disease. Moreover, the DOD has been forward thinking in introducing new ways to efficiently study future therapies across a broad range of patient groups by investing in novel pragmatic clinical trial infrastructure that will integrate VA Medical Centers with the PFF care network,” Dr. Martinez said.
The overall program aims to screen 800 patients, with roughly 400 of the patients identified as being at increased risk; the latter patients will be treated with either metformin or a matched placebo.
“This marks a novel collaboration between the Pulmonary Fibrosis Foundation, the Department of Defense and the Department of Veterans Affairs—creating a model for future pulmonary fibrosis clinical trials and expanding access for veterans historically underrepresented in this research,” said Bhavika Kaul, MD, physician-investigator for the Department of Veterans Affairs Center for Innovation in Quality, Effectiveness and Safety. Dr. Kaul is serving as the VA national lead for this trial.
Amy Hajari Case, MD, chief medical officer for PFF, said, "With 55 of our PFF Care Center sites engaged in the study, we are proud to help move this research from concept to impact for people living with IPF."
Key partners involved on the study’s steering committee include Elizabeth Peters, BSN, RN, senior research program director of the Department of Medicine Clinical Research Core at UMass Chan; and representatives from the Department of Veterans Affairs, led by the Michael E. DeBakey VA Medical Center in Houston, Texas; the University of Michigan; Mass General Brigham; Weill Cornell Medicine; Mayo Clinic; the University of Maryland; the University of Virginia; the University of Southern California; the University of Washington; Temple University; Tulane University; and the University of North Carolina at Chapel Hill.
“Metformin is being studied for numerous indications, because it’s believed to have anti-aging properties. Idiopathic pulmonary fibrosis, which is what the DOD grant is targeting, is an abnormality that reflects accelerated lung aging,” said Andrew Limper, MD, professor of medicine, biochemistry and molecular biology, and head of the Thoracic Diseases Research Unit at Mayo Clinic Limper said.
The planning phase of the project is supported by a $625,000 grant from the DOD. Following the conclusion of the planning phase and completion of milestones, investigators will apply for an additional $17.3 million for a clinical trial through the Peer Reviewed Medical Research Program.
