Clinical Trial Will Evaluate Saracatinib in Idiopathic Pulmonary Fibrosis
Researchers at the Icahn School of Medicine at Mount Sinai, National Jewish Health, and the Yale School of Medicine have been granted $4.7 million by the National Center for Advancing Translational Sciences to conduct phase 1b/2a clinical trials of the experimental medication saracatinib to treat idiopathic pulmonary fibrosis (IPF).
IPF is a serious, progressive disease that causes scarring of the lungs and other disabling pulmonary symptoms. The numbers of patients with this illness and of those newly diagnosed are increasing. The cause is not known and no cure has been discovered. Two medications, ninetedanib and pirfenidone, are approved for treatment of the disease. Both medications slow the progress of scarring, but do not cure the disease or improve quality of life.
Saracatinib, an experimental medication produced by AstraZeneca, inhibits the activity of Src kinases, enzymes that speed up chemical reactions in molecules of the body. Many kinases participate in cellular signaling associated with fibrosis. Originally developed as a cancer treatment, saracatinib was selected for possible effectiveness against IPF after genomic studies demonstrated overlap in the genes and signaling pathways relevant in IPF and those affected by saracatinib.
The Saracatinib in the Treatment of Patient with Idiopathic Pulmonary Fibrosis (STOP IPF) trial will enroll 100 participants with idiopathic pulmonary fibrosis to receive either saracatinib or placebo for 24 weeks. Researchers will evaluate safety and tolerability of saracatinib in IPF, identify relevant biomarkers of Src kinase activity and fibrogenesis, and explore early indicators of saracatinib efficacy. The Medicine Clinical Trials Office at Mount Sinai will be involved in the implementation and oversight of this study
“The STOP IPF trial is an exciting study that will take us beyond the landmark trials that brought us the antifibrotic medications which slow progression of IPF, a relentless disease,” said Maria Padilla, MD, Director of the Pulmonary Fibrosis and Interstitial Lung Disease Program and Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine at Mount Sinai. “With this trial we aim to demonstrate efficacy of saracatinib and at the same time gain greater understanding of fibrosis and of biomarkers that can be used to guide response to treatment of IPF. We are proud to be part of this important multi-center study and look forward to its successful enrollment and completion.”
Greg Downey, MD, Professor of Medicine at National Jewish Health, and Naftali Kaminski, MD, Professor of Medicine at the Yale School of Medicine, are co-Principal Investigators in the trial.
The Icahn School of Medicine at Mount Sinai, a top-ranked academic medical center in New York City, and National Jewish Health, the nation’s leading respiratory hospital based in Denver, Colorado, have partnered to create the Mount Sinai – National Jewish Health Respiratory Institute. To learn more about the Mount Sinai – National Jewish Health Respiratory Institute, visit our website, Facebook, or Twitter.
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