The randomized, double-blind, placebo-controlled trial enrolled 161 patients at more than 50 sites in the US, UK, EU, Turkey and South Korea. Patients were randomized 3:2 to monthly intravenous CAL101 or placebo for six months. The primary endpoint is the change from baseline in forced vital capacity, a measure of lung function. Circulating biomarkers and quantitative high-resolution CT imaging are additional assessments.

An independent data monitoring committee has completed its final review of unblinded safety data and found nothing requiring changes to the study, which now continues into final follow-up.

CAL101 is a monoclonal antibody that neutralizes extracellular S100A4, a protein linked to fibroblast activation and pro-fibrotic immune responses in IPF.

Jonas Hallén, Co-Founder and Chief Medical Officer of Calluna, called completing dosing “an important milestone for the AURORA study”.