OSLO, Norway & BOSTON — Calluna Pharma AS has completed patient enrollment in its Phase 2 AURORA study evaluating CAL101 as a potential treatment for idiopathic pulmonary fibrosis (IPF), finishing more than six months ahead of schedule.
The global trial enrolled 161 adult patients across more than 50 sites in the United States, United Kingdom, Europe, Turkey, and South Korea. The randomized, double-blind, placebo-controlled study is designed to assess the safety and effectiveness of CAL101, with a primary focus on lung function measured by changes in forced vital capacity.
Participants underwent a 28-day screening period before being randomly assigned to receive monthly intravenous infusions of CAL101 or a placebo over six months. The study uses a 3:2 randomization ratio. Topline results are expected in the first quarter of 2027.
“The completion of enrollment in AURORA is an important operational milestone for Calluna,” said Jonas Hallén, M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma. “We are deeply grateful to the patients who chose to participate in this study, and to the investigators and site teams whose commitment and efficiency enabled rapid enrollment across a broad range of countries and sites. Their collective effort has positioned us well to generate high-quality data on the safety and potential efficacy of CAL101 in IPF.”
“We are thrilled with the rapid and high-quality execution of the AURORA study,” said Mark Gaffney, Chief Executive Officer and Board member of Calluna Pharma. “AURORA enables us to have a comprehensive understanding of CAL101 and its readiness for late-stage and pivotal studies in pulmonary fibrosis as well as its potential in other inflammatory or fibrotic diseases.”
CAL101 is a monoclonal antibody designed to target S100A4, a protein associated with tissue stress and fibrosis. By blocking this pathway, the therapy aims to reduce abnormal scar tissue formation and preserve lung function in patients with IPF.
Earlier Phase 1 data showed the treatment had a favorable safety profile along with pharmacological activity consistent with its intended mechanism. Preclinical studies have also indicated the drug may help prevent and treat fibrosis by limiting the activation of fibroblasts and related immune responses.
