Clinical Trial to Evaluate Saracatinib in Idiopathic Pulmonary Fibrosis

Researchers at National Jewish Health, the Yale School of Medicine and the Icahn School of Medicine at Mount Sinai have been awarded $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. Saracatinib inhibits the activity of Src kinases, many of which participate in cellular signaling associated with fibrosis.

“Our previous work has shown that saracatinib is more effective than currently approved medications at slowing fibrosis in cell cultures and animal models,” said Greg Downey, MD, professor of medicine at National Jewish Health and principal investigator for the trial. “We believe it holds promise as a new treatment for idiopathic pulmonary fibrosis.”

Idiopathic pulmonary fibrosis is a progressive scarring disease of the lungs. Its cause is unknown and patients usually die of respiratory failure within two to four years after diagnosis. Two medications, nintedanib and pirfenidone, are currently approved for treatment of the disease. Both medications slow the progress of scarring, but do not cure the disease or improve quality of life in patients. They also produce side effects that cause many patients to discontinue use.

Saracatinib is an experimental medication originally developed by AstraZeneca for the treatment of cancer. Saracatinib was selected for possible effectiveness against idiopathic pulmonary fibrosis after genetic studies demonstrated overlap in the genes and signaling pathways relevant in idiopathic pulmonary fibrosis and in those affected by saracatinib.

The Saracatinib in the Treatment of Patients 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 the safety and tolerability of saracatinib in idiopathic pulmonary fibrosis; identify relevant biomarkers of Src kinase activity and fibrogenesis; and explore early indicators of saracatinib efficacy.

Co-principal investigators with Dr. Downey are Maria Padilla, MD, at the Icahn School of Medicine at Mount Sinai, and Naftali Kaminski, MD, at the Yale School of Medicine.