Calluna Pharma Completes Dosing in Phase 2 AURORA Study of CAL101 in Idiopathic Pulmonary Fibrosis and Reports Completion of Final Independent Safety Review

Final independent safety review identifies no findings warranting study changes and recommends that AURORA continue as planned

All patients have completed dosing in the global AURORA study evaluating the efficacy and safety of CAL101 in adults with IPF; topline results expected in Q1 2027

OSLO, Norway & BOSTON--(BUSINESS WIRE)--Calluna Pharma AS (Calluna), a clinical-stage biotechnology company pioneering first-in-class antibodies for inflammatory and fibrotic diseases, today announced completion of dosing in the Phase 2 AURORA study of CAL101 in idiopathic pulmonary fibrosis (IPF). In parallel, the Independent Data Monitoring Committee (IDMC) completed its final review of unblinded safety data from 161 patients enrolled in AURORA and identified no findings warranting modifications to the study. The fully enrolled global study has now entered its final follow-up phase ahead of topline results expected in Q1 2027.

“Completion of dosing marks an important milestone for the AURORA study and brings us a step closer to understanding the potential of CAL101 in IPF,” said Jonas Hallén, M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma. “We are deeply grateful to the patients and families who participated in the study, as well as the investigators, study coordinators and site teams whose commitment made this achievement possible. We also appreciate the diligence and expertise of the IDMC members throughout the trial. With treatment now complete and follow-up ongoing, we look forward to topline results in the first quarter of 2027.”

CAL101 is a systemically administered monoclonal antibody designed to neutralize extracellular S100A4, a damage-associated molecular pattern protein involved in inflammatory and fibrotic signaling. S100A4 is associated with the pathological activation and proliferation of fibroblasts and pro-fibrotic immune responses implicated in the progression of fibrotic disease. By targeting an upstream amplifier of multiple disease-related pathways, CAL101 is designed to interrupt persistent and maladaptive signaling without broadly suppressing normal physiological processes.

About the AURORA Study

AURORA is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of CAL101 in adults with IPF. The global study enrolled 161 patients across more than 50 sites in the United States, United Kingdom, European Union, Turkey and South Korea. Participants were randomized at a 3:2 ratio to receive monthly intravenous infusions of CAL101 or placebo for six months. The study’s primary endpoint is the change from baseline in forced vital capacity, a measure of lung function. Additional assessments include circulating biomarkers and quantitative high-resolution computed tomography imaging. Topline results are expected in Q1 2027. Additional information about AURORA is available at ClinicalTrials.gov using the identifier NCT06736990.

About Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis is a progressive lung disease in which an abnormal wound-healing response causes lung tissue to become thickened and scarred, making it increasingly difficult to breathe. The disease primarily affects older adults and can lead to respiratory failure and death. Despite recent advances, there remains a need for new therapies that can preserve lung function while remaining suitable for chronic treatment.

About Calluna Pharma

Calluna Pharma is a global clinical-stage biotechnology company pioneering a new approach to treating inflammatory and fibrotic diseases by targeting upstream amplifiers of disease. The Company is developing a pipeline of selective antibodies designed to interrupt pathological signaling across multiple downstream pathways while preserving normal physiological function. Calluna is incorporated in Oslo, Norway and operates globally.

For more information, visit www.callunapharma.com