Calluna Pharma AS has completed dosing in its Phase 2 AURORA study of CAL101 for idiopathic pulmonary fibrosis (IPF), bringing the clinical-stage biotechnology company closer to reporting results expected in the first quarter of 2027.

 

The company also announced that the Independent Data Monitoring Committee (IDMC) has completed its final review of unblinded safety data from 161 patients enrolled in the trial, identifying no findings that warrant modifications to the study.

 

With enrolment complete and dosing finished, the global trial has entered its final follow-up phase ahead of the anticipated topline results.

 

CAL101 is being developed by Calluna Pharma, which is focused on pioneering first-in-class antibodies for inflammatory and fibrotic diseases. The AURORA study is evaluating the investigational treatment in patients with IPF, a progressive lung disease.

 

“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, 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.”

 

The completion of dosing and the latest IDMC review mark key milestones for AURORA as Calluna moves towards its next major clinical update. The trial's topline results, expected in Q1 2027, are anticipated to provide further insight into CAL101's potential in IPF.