OSLO, Norway, and BOSTON, Massachusetts — October 13, 2026
Calluna Pharma AS announced that all patients have completed dosing in the Phase 2 AURORA clinical trial evaluating CAL101 in adults with idiopathic pulmonary fibrosis (IPF). The global study has entered its final follow-up phase, with topline results expected in the first quarter of 2027. In a separate milestone, the Independent Data Monitoring Committee (IDMC) completed its final review of unblinded safety data from all 161 enrolled patients and identified no findings requiring changes to the study. The committee recommended that AURORA continue as planned. The trial is assessing the efficacy and safety of CAL101, an investigational monoclonal antibody designed to target extracellular S100A4, a protein involved in inflammatory and fibrotic signaling. The completion of dosing marks an important step toward evaluating the candidate’s potential role in addressing the unmet treatment needs of people living with progressive lung disease.
AURORA Trial Completes Dosing With Safety Oversight
The AURORA Phase 2 study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate CAL101 in adults with IPF. It enrolled 161 patients across more than 50 clinical sites in the United States, United Kingdom, European Union, Turkey and South Korea. Participants were randomized in a 3:2 ratio to receive monthly intravenous infusions of CAL101 or placebo over six months. With dosing now complete, participants are progressing through the final follow-up phase before the planned topline data announcement. The IDMC reviewed unblinded safety data and concluded that there were no findings warranting modifications to the study, recommending continuation according to the existing protocol. This independent safety review is an important component of clinical trial oversight, although it does not establish the treatment’s efficacy or guarantee that no safety concerns will emerge from subsequent analyses. The study’s upcoming results are expected to provide the first major Phase 2 assessment of CAL101’s clinical performance in IPF.
CAL101 Targets S100A4-Associated Fibrotic Signaling
CAL101 is an investigational, systemically administered monoclonal antibody designed to neutralize extracellular S100A4, a damage-associated molecular pattern protein implicated in inflammatory responses and fibrosis. S100A4 is associated with the activation and proliferation of fibroblasts and with pro-fibrotic immune responses that may contribute to disease progression. Calluna Pharma’s approach is intended to target an upstream amplifier of multiple disease-related pathways rather than broadly suppressing normal physiological processes. By interrupting pathological signaling, CAL101 is being developed with the aim of addressing mechanisms involved in persistent inflammation and tissue scarring. However, its proposed biological effects and potential clinical benefits remain under investigation. The AURORA trial is designed to determine whether targeting S100A4 translates into measurable benefits for patients with IPF. The forthcoming results will be important for understanding the candidate’s effect on lung function, its safety profile and the potential rationale for further clinical development.
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Lung Function Data Expected in First Quarter of 2027
The primary endpoint of AURORA is the change from baseline in forced vital capacity (FVC), a standard measure of lung function that assesses the amount of air a person can forcibly exhale after taking a deep breath. The trial also includes assessments of circulating biomarkers and quantitative high-resolution computed tomography imaging to provide additional information about biological activity and changes in the lungs. Topline results are expected in Q1 2027, following completion of the study’s follow-up phase and analysis of the collected data. The study is registered on ClinicalTrials.gov under identifier NCT06736990. Idiopathic pulmonary fibrosis is a chronic, progressive disease characterized by abnormal wound healing and irreversible scarring of lung tissue, which can increasingly impair breathing and may lead to respiratory failure. Although treatment options have advanced, preserving lung function and finding therapies suitable for long-term use remain important clinical goals. Calluna Pharma’s completion of dosing brings CAL101 closer to a key data milestone, but its efficacy and overall benefit-risk profile will depend on the full trial results.
Source::Calluna Pharma, press release
