News

Calluna Pharma Announces Initiation of Phase 2 AURORA Study of CAL101 for Idiopathic Pulmonary Fibrosis

augustus 26, 2025

Human Health

Portfolio

CAL101 is a first-in-class monoclonal antibody targeting S100A4, a damage-associated molecular pattern (DAMP) protein associated with serious and life-threatening fibrotic disorders
Phase 2 AURORA study of CAL101 designed to prevent lung function decline in adult patients with idiopathic pulmonary fibrosis (IPF)

Oslo, Norway and Boston, Massachusetts, 26 August 2025: Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that the first patients have been dosed in the Phase 2 AURORA study of CAL101 for IPF.

AURORA is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with IPF. The study aims to enroll 150 individuals with IPF across more than 50 sites, primarily in the US, UK, EU, Turkey and South Korea. After an initial 28-day screening period, patients will be randomized to receive seven monthly intravenous infusions of CAL101 or placebo at a randomization ratio of 3:2, respectively.The study’s primary endpoint is lung function, measured by forced vital capacity, or how much air can forcibly be exhaled, versus an individual’s baseline.

Current treatments for IPF fall short, leaving a significant unmet need for therapies that are both more effective and better tolerated. CAL101 offers a novel, dual anti-fibrotic and anti-inflammatory approach. By addressing the multiple dysregulated pathways that drive disease progression, it holds significant promise for IPF patients.

Dr. Toby Maher, MD, PhD

Professor of Clinical Medicine at the Keck School of Medicine at USC and Coordinating Investigator on the AURORA study.

Dosing our first patients in the AURORA study is a significant milestone for Calluna Pharma. This marks a significant step forward in our mission to develop a novel therapy for IPF that targets the underlying drivers of the disease. The AURORA study is designed to demonstrate CAL101’s potential to impact lung function decline in a well-tolerated manner, which would offer a much-needed treatment advance for a progressive and life-threatening disease.

Jonas Hallén, MD, PhD

Co-Founder and Chief Medical Officer of Calluna Pharma

Media Contact

Jason Glashow
Glashow Strategic Communications
Email: Jason@glashowstrategic.com
Tel: +1 617-510-1800

About CAL101

CAL101 is a systemically administered monoclonal antibody targeting the DAMP protein S100A4. S100A4 is activated when tissue is stressed or injured, triggering multiple downstream pathways. It is associated with pathological activation and proliferation of fibroblasts (the key effector cells driving progression of fibrosis), and pro-fibrotic immune response connected to fibrotic disease. Targeting S100A4 has the potential to re-establish tissue homeostasis by switching off the downstream pathways involved in the persistent and maladaptive scar tissue formation characteristic of IPF.

A randomized, double-blind, placebo-controlled Phase 1 study of CAL101 demonstrated a favorable safety profile, with balanced frequency and types of AEs, compared to placebo, across all dose levels. Preclinical studies have shown CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease where an inappropriately activated wound-healing response causes the lung tissue to become thickened and scarred, making it difficult to breathe. The exact triggers of IPF are unknown, but it is believed to be a combination of genetic and environmental factors. Over time, the scarring in the lungs worsens, leading to respiratory failure and ultimately death, with a 3-5-year median survival rate. Primarily found in older adults, the disease impacts approximately 233,000 people in the US and EU.

About Calluna Pharma

Calluna Pharma is a global clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The Company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases with enhanced efficacy and tolerability. Calluna Pharma is incorporated in Oslo, Norway and operates globally.

About us

Strategies