BOSTON– Calluna Pharma AS has dosed the first patients in its Phase 2 AURORA study of CAL101, a monoclonal antibody targeting S100A4 for the treatment of idiopathic pulmonary fibrosis (IPF).
AURORA is a randomized, double-blind, placebo-controlled study enrolling 150 patients with IPF at more than 50 sites in the U.S., UK, EU, Turkey, and South Korea. After a 28-day screening period, participants will receive seven monthly intravenous infusions of CAL101 or placebo at a 3:2 ratio. The trial’s primary endpoint is lung function, measured by forced vital capacity (FVC).
“Current treatments for IPF fall short, leaving a significant unmet need for therapies that are both more effective and better tolerated,” said Dr. Toby Maher, M.D., Ph.D., Professor of Clinical Medicine at the Keck School of Medicine at USC and Coordinating Investigator on the study. “CAL101 offers a novel, dual anti-fibrotic and anti-inflammatory approach. By addressing the multiple dysregulated pathways that drive disease progression, it holds significant promise for IPF patients.”
“Dosing our first patients in the AURORA study is a significant milestone for Calluna Pharma,” said Jonas Hallén, M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma. “The study is designed to demonstrate CAL101’s potential to slow lung function decline in a well-tolerated manner, which would represent an important advance for patients with this progressive and life-threatening disease.”
