Calluna Pharma AS, a clinical stage biotechnology company based in Norway, on Tuesday announced the dosing of the first patients in its Phase 2 AURORA trial evaluating CAL101, a first-in-class monoclonal antibody for idiopathic pulmonary fibrosis (IPF).

The study is designed to assess whether CAL101 can prevent lung function decline in adult patients with the progressive and life-threatening lung disease.

AURORA is a randomised, double-blind, placebo-controlled study enrolling 150 patients across more than 50 sites in the US, UK, EU, Turkey, and South Korea. Participants will receive seven monthly intravenous infusions of CAL101 or placebo, with the primary endpoint measuring forced vital capacity against baseline.

CAL101 targets the S100A4 protein, a damage-associated molecular pattern linked to fibroblast activation and pro-fibrotic immune responses. By blocking S100A4 signalling, the therapy aims to reduce maladaptive scar tissue formation and restore tissue balance.

A prior Phase 1 trial demonstrated a favourable safety profile for CAL101, while preclinical studies showed potential in preventing and treating fibrosis.

IPF affects about 233,000 people in the United States and European Union, with median survival estimated at three to five years after diagnosis.