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news.Celtaxsys, a clinical stage drug development company focused on advancing therapies for patients with rare and orphan inflammatory diseases, announced the opening of enrollment in Europe of an international phase 2 clinical trial for acebilustat, its flagship treatment for people with cystic fibrosis (CF).
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The study, termed EMPIRE-CF (Evaluating Modulation of the Pulmonary Inflammatory Response in CF), will include approximately 30 sites across the EU, with sites in the United Kingdom, France, Italy, Germany, and Belgium.
The trial 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 novel anti-inflammatory therapy designed to prevent long-term loss of lung function in CF patients.
Acebilustat 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. The US sites in the EMPIRE-CF study are already enrolling patients.
Acebilustat is a first-in-class neutrophil modulator that controls a key inflammatory signal overexpressed in CF and other inflammatory diseases.
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 just two weeks of treatment. These results were accomplished without jeopardizing the patient’s immune response to lung infection.
This Phase 2 CF trial is supported by a grant from Cystic Fibrosis Foundation Therapeutics (CFFT), the non-profit drug discovery and development affiliate of the CF Foundation. The trial was designed in conjunction with CFFT and the European CF Clinical Trial Network (CTN).
The European portion of the EMPIRE-CF study will be under the supervision of Principal Investigator Professor Stuart Elborn, Dean of the School of Medicine, Dentistry and Biomedical Sciences, Queen’s University, Belfast.
Professor Elborn said, "Anti-inflammatory therapies (AITs) represent the next wave of treatments for CF. In conjunction with the CFTR modulators and other emerging therapies, AITs like acebilustat have the potential to significantly preserve lung function and extend life expectancy for CF patients."