BOSTON — Calluna Pharma, a clinical-stage biotechnology company developing antibody therapies for inflammatory and fibrotic diseases, has completed patient dosing in its Phase 2 AURORA clinical trial evaluating CAL101 for the treatment of idiopathic pulmonary fibrosis (IPF).
The company also announced that an independent data monitoring committee completed its final safety review of the 161 patients enrolled in the study and identified no findings requiring changes to the trial.
The global study has entered its final follow-up phase, with topline results expected in the first quarter of 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,” Hallén added.
CAL101 is an investigational monoclonal antibody designed to neutralize extracellular S100A4, a protein involved in inflammatory and fibrotic signaling.
The protein is associated with the abnormal activation and proliferation of fibroblasts, cells that contribute to tissue scarring, as well as immune responses linked to the progression of fibrotic diseases.
By targeting S100A4, Calluna aims to interrupt multiple disease-related pathways involved in inflammation and fibrosis without broadly suppressing normal physiological functions.
The AURORA trial is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety and effectiveness of CAL101 in adults with idiopathic pulmonary fibrosis.
The study enrolled 161 patients across more than 50 clinical sites in the United States, United Kingdom, European Union, Turkey and South Korea.
Participants were randomly assigned in a 3:2 ratio to receive monthly intravenous infusions of CAL101 or a placebo over six months.
The trial’s primary endpoint is the change in forced vital capacity, a measure of how much air a person can forcibly exhale after taking a deep breath. Researchers are also evaluating blood-based biomarkers and high-resolution computed tomography imaging to assess changes associated with the disease.
Idiopathic pulmonary fibrosis is a progressive lung disease characterized by abnormal scarring of lung tissue, which gradually reduces lung function and makes breathing increasingly difficult.
The condition primarily affects older adults and can eventually lead to respiratory failure and death. Although treatments are available to slow disease progression, additional therapies are needed to preserve lung function and support long-term disease management.
Calluna said the independent safety committee’s recommendation allows the AURORA study to proceed as planned through its remaining follow-up period.
The company expects to report initial efficacy and safety findings in the first quarter of 2027. The completed safety review does not establish whether CAL101 is effective, which will be assessed when the trial results become available.
