CAL101 Phase 2 trial in IPF completes enrollment ahead of schedule
Calluna expects data from the AURORA study in early 2027
Written by |
Enrollment has finished ahead of schedule in a Phase 2 clinical trial testing Calluna Pharma‘s experimental antibody therapy CAL101 in people with idiopathic pulmonary fibrosis (IPF).Â
The Phase 2 study, dubbed AURORA (NCT06736990), was designed to enroll about 150 adults with IPF, ages 40 and older, with enrollment expected to run through late this year. But Calluna announced that the study has completed enrollment with 161 participants, more than six months ahead of schedule. The trial is taking place in the U.S. and multiple other countries.
“We are thrilled with the rapid and high-quality execution of the AURORA study,” Mark Gaffney, CEO and board member of Calluna, said in a company press release.
AURORA study is testing CAL101’s effect on lung function
Participants in the AURORA study are receiving infusions of either CAL101 or a placebo every four weeks, either as a standalone therapy or in addition to currently approved antifibrotic treatments. The main goal of the study is to see if CAL101 is meaningfully better than the placebo at preserving lung function, as measured by changes in forced vital capacity (FVC), a standard assessment of lung function that measures how much air a person can blow out with a single forceful breath.
Calluna hopes to use results from the study to inform plans for the therapy’s further development. The company said it expects to announce results from the study in the first quarter of 2027.
“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,” Gaffney said.
“The completion of enrollment in AURORA is an important operational milestone for Calluna,” added Jonas Hallén, MD, PhD, co-founder and chief medical officer of 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 enrollment 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.”
IPF is a chronic disorder marked by scarring, also known as fibrosis, in the lungs. Fibrosis in IPF is driven in large part by abnormal activation of fibroblasts, structural cells that help produce scar tissue. CAL101 is designed to block S100A4, a protein linked to fibroblast activation and pro-fibrotic immune responses. CAL101 showed a favorable safety profile in a Phase 1 trial.
