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news.Norway-based biotechnology company Calluna Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, CAL101.
CAL101 is a monoclonal antibody that targets the S100A4, a type of damage-associated molecular pattern (DAMP) protein. Credit: Julia Koblitz/Unsplash.
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CAL101 is intended for the treatment of idiopathic pulmonary fibrosis (IPF).
It is currently studied in the Phase II AURORA trial, with patient recruitment underway in the US, UK, European Union (EU), Turkey and South Korea.
The ongoing randomised, double-blind, placebo-controlled study plans to enrol 150 participants diagnosed with IPF across over 50 clinical sites.
Following a 28-day screening period, eligible patients will be randomised into a 3:2 ratio to receive either CAL101 or a placebo through seven monthly intravenous infusions.
The primary endpoint of the study includes the change in lung function, specifically forced vital capacity, compared to baseline values.
CAL101 is a monoclonal antibody that works by targeting the S100A4 protein, a type of damage-associated molecular pattern (DAMP) protein.
Previous clinical studies have assessed the safety profile of CAL101.
In Phase 1 trials, CAL101 showed a similar frequency and type of adverse events compared to placebo groups across all tested doses.
Preclinical research indicated that the therapy could prevent and treat fibrosis by modifying the disease-specific activation of fibroblasts.
Calluna Pharma clinical operations and pharmacovigilance senior vice president Margrethe Sørgaard said: “Orphan drug designation speaks to the importance of developing new treatments for debilitating rare diseases like IPF, for which treatment options are limited.
“Our ongoing IPF study (AURORA) aims to demonstrate that CAL101 prevents the disease-specific activation of fibroblasts that lead to decreased lung function, and the progressive decline these patients face.”
