Calluna Pharma has completed enrollment in its global Phase 2 AURORA study of CAL101 for idiopathic pulmonary fibrosis, enrolling 161 adult patients across more than 50 sites in the US, UK, EU, Turkey and South Korea.
The randomized, double-blind, placebo-controlled trial used a 3:2 randomization and followed a 28-day screening period, followed by monthly intravenous infusions of CAL101 or placebo for six months.
The study’s primary endpoint is the change from baseline in forced vital capacity, and enrollment finished more than six months ahead of schedule. Calluna anticipates topline data in the first quarter of 2027.
CAL101 is a systemically administered monoclonal antibody that targets the damage-associated protein S100A4 and is intended to preserve lung function in IPF.
The company claims a Phase 1 study showed a favorable safety profile and predictable pharmacokinetics, and that preclinical work demonstrated prevention and treatment of fibrosis. The company also notes that IPF has a median survival of 3 to 5 years and affects roughly 233,000 people in the US and EU.
