Clinical stage drug development company Celtaxsys has started enrolling subjects in Europe for a global Phase ll clinical trial of its acebilustat anti-inflammatory therapy to treat people with cystic fibrosis (CF).
CF, caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene, affects the lung and digestive system and impacts about 70,000 patients across the globe.
The study, titled Evaluating Modulation of the Pulmonary Inflammatory Response in CF (EMPIRE-CF), will include around 30 sites across the European Union (EU), with sites in the UK, France, Italy, Germany, and Belgium.
EMPIRE-CF will test the safety and efficacy of once-daily oral acebilustat over 48 weeks of treatment, and could establish the first proof-of-concept for a new anti-inflammatory therapy designed to prevent long-term loss of lung function in CF patients.
The study has already started enrolling patients in the US.
Acebilustat is a neutrophil modulator that controls a major inflammatory signal overexpressed in CF and other inflammatory diseases, and is being tested against placebo on top of background therapy, including CFTR modulators Kalydeco and Orkambi, in adult CF patients irrespective of their specific CF gene mutation.
Celtaxsys noted that a previous clinical study in CF patients demonstrated acebilustat's ability to modulate the over-activated inflammatory response associated with CF lungs, decreasing neutrophils in the lung by 65% and reducing damaging neutrophil elastase levels in two weeks of treatment.
These results were obtained without jeopardising the patient's immune response to lung infection.
Designed by Cystic Fibrosis Foundation Therapeutics (CFFT) and European CF Clinical Trial Network (CTN), EMPIRE-CF is supported by a CFFT grant.
The European portion of the study will be supervised by principal investigator Stuart Elborn, who is a professor at Dean of the School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, Northern Ireland.