Calluna Pharma has concluded patient enrolment ahead of schedule in its global Phase II AURORA clinical trial evaluating CAL101 for idiopathic pulmonary fibrosis (IPF).
The randomised, double-blind, placebo-controlled trial has enrolled 161 adult participants at over 50 sites across South Korea, Turkey, the European Union, the UK, and the US.
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The primary objective is to assess lung function, specifically changes in forced vital capacity (FVC) from baseline.
Participants entered AURORA after a 28-day screening period and were then randomised in a 3:2 ratio to receive either monthly intravenous infusions of CAL101 or placebo over a six-month period.
Topline data from the trial are expected in the first quarter of 2027.
CAL101 is a monoclonal antibody that targets the damage-associated molecular pattern (DAMP) protein S100A4.
Previous Phase I data indicated a favourable safety profile and disease-modifying potential.
IPF is a progressive condition marked by scarring of lung tissue that impedes breathing and function.
Calluna Pharma co-founder and chief medical officer Jonas Hallén said: “The completion of enrolment in AURORA is an important operational milestone for Calluna.
“We are deeply grateful to the patients who chose to participate in this study, and to the investigators and site teams whose commitment and efficiency enabled rapid enrolment across a broad range of countries and sites. Their collective effort has positioned us well to generate high-quality data on the safety and potential efficacy of CAL101 in IPF.”
Calluna Pharma CEO and board member Mark Gaffney said: “We are thrilled with the rapid and high-quality execution of the AURORA study. AURORA enables us to have a comprehensive understanding of CAL101 and its readiness for late-stage and pivotal studies in pulmonary fibrosis as well as its potential in other inflammatory or fibrotic diseases.”
In October 2024, Calluna Pharma concluded the Phase I clinical study of its lead product, CAL101, for fibrotic and fibro-inflammatory indications.
