Calluna Pharma Receives U.S. FDA Orphan Drug Designation for CAL101 in Idiopathic Pulmonary Fibrosis
Saturday, November 01, 2025
Calluna Pharma AS, a clinical-stage biotechnology company focused on developing novel antibodies for inflammatory and fibrotic diseases, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAL101, its lead candidate currently under evaluation for idiopathic pulmonary fibrosis (IPF).
The designation supports the development of new therapies for rare diseases that affect fewer than 200,000 people in the United States. It provides several benefits, including eligibility for accelerated review pathways, tax credits for clinical trials, exemption from certain regulatory fees, and seven years of market exclusivity following approval.
The company’s ongoing AURORA study is a randomised, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of CAL101 in patients with IPF. The trial aims to recruit 150 participants across more than 50 study sites in the USA, UK, EU, Turkey, and South Korea. Following a 28-day screening phase, participants will receive seven monthly intravenous infusions of either CAL101 or placebo, with randomisation in a 3:2 ratio. The study’s primary goal is to measure lung function, assessed by forced vital capacity in comparison with baseline levels.
CAL101 is a monoclonal antibody administered systemically and designed to target the DAMP protein S100A4. This protein becomes active when tissue is damaged or stressed, triggering several biological pathways that lead to abnormal fibroblast activation and fibrosis. By inhibiting S100A4, CAL101 aims to restore tissue balance and reduce the persistent scar tissue formation associated with IPF.
A Phase 1 randomised, double-blind, placebo-controlled study demonstrated a favourable safety profile for CAL101, with adverse events similar in frequency and type to those seen in the placebo group across all tested doses. Preclinical studies have also shown that CAL101 can prevent and treat fibrosis by modifying disease-specific fibroblast activation.
Source: businesswire.com
