Calluna Pharma has completed patient dosing in its Phase II AURORA trial of CAL101 to treat idiopathic pulmonary fibrosis (IPF).
The study has now transitioned into its final follow-up phase, with topline findings scheduled for release in the first quarter of 2027.
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Concurrently, the Independent Data Monitoring Committee (IDMC) concluded its review of unblinded safety information from the trial and identified no concerns warranting alterations to the study.
IDMC reviewed safety data from all 161 patients enrolled in the trial. Patients were randomised at a 3:2 ratio to receive monthly intravenous infusions of either CAL101 or a placebo over a six-month period.
The primary endpoint is the change from baseline in forced vital capacity, a measure of lung function, with circulating biomarkers and quantitative high-resolution computed tomography scans also being evaluated.
Calluna Pharma co-founder and chief medical officer Jonas Hallén said: “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.
“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.”
Patient recruitment spanned upwards of 50 clinical centres across the European Union (EU), South Korea, Turkey, the UK, and the US.
CAL101 is an intravenously delivered monoclonal antibody developed to neutralise extracellular S100A4, a damage-associated molecular pattern protein linked to inflammatory and fibrotic cascades.
S100A4 contributes to abnormal fibroblast proliferation and pro-fibrotic immune activity.
By targeting this upstream disease amplifier, the candidate is designed to block persistent signalling pathways without broadly suppressing healthy physiological functions.
IPF is a progressive lung disorder where anomalous wound healing leads to irreversible tissue thickening and scarring, making breathing increasingly difficult.
In October 2024, Calluna Pharma concluded the Phase I clinical study of its lead product, CAL101, for fibrotic and fibro-inflammatory indications.
