ATLANTA, Oct. 11, 2018 — Full results from the recently completed Phase 2 trial (EMPIRE-CF) of Celtaxsys’ acebilustat will be presented at the North American Cystic Fibrosis Conference to be held October 18-20, 2018 in Denver, Colorado.
Previously reported top-line results highlighted that acebilustat is the first novel anti-inflammatory molecule to prospectively exhibit potential to reduce rate of pulmonary exacerbations (PEx) and prolong time to first exacerbation in cystic fibrosis (CF) patients. Patients with less severe impairment of lung function achieved the largest benefit from acebilustat treatment, achieving a 35% reduction in PEx rate, a 43% reduction in risk of experiencing their first exacerbation over the course of the trial, and a 96% increased likelihood of being exacerbation free after 48 weeks of treatment as compared to placebo. Furthermore, patients concomitantly treated with CFTR modulator therapy exhibited a clinically meaningful 20% reduction in PEx, a 29% increased time to first exacerbation and a 47% higher likelihood of no exacerbations compared to patients treated with CFTR modulators and placebo.
Celtaxsys, with continued support from the CF Foundation, has commenced preparations for designing and executing the acebilustat Phase 3 clinical program.
Details on the presentations that will include the results of the Phase 2 trial are as follows:
|Thematic Poster Session Title: Clinical Care in the Era of CFTR Modulators|
|Poster Title: A Phase 2 Trial (EMPIRE CF) of a Novel Anti-Inflammatory Molecule, Acebilustat, in Patients with CF|
|Presenter: Dr. J. Stuart Elborn|
|Date: Thursday, October 18, 2018 Session Time: 9:45 – 11:05 a.m. MDT|
|Location: Room 702|
|Plenary Session Title: Anti-inflammatories & Mucociliary Clearance Therapies in the Age of CFTR Modulators|
|Presenter: Dr. Felix Ratjen|
|Date: Friday, October 19, 2018 Time: 9:00 – 10:00 a.m. MDT|
|Location: Bellco Theatre|
|Symposium Session Title: Resolution of Inflammation in CF Airways: CFTR & Beyond|
|Symposium Session Time: 2:30 – 3:55 p.m. MDT|
|Symposium Presentation Title: A Phase 2 Trial (EMPIRE CF) of a Novel Anti-Inflammatory Molecule, Acebilustat, in Patients With CF|
|Presenter: Dr. Steven Rowe|
|Date: Saturday, October 20, 2018 Presentation Time (approximate): 3:35 – 3:50 p.m. MDT|
|Location: Room 505|
Additional details can be found on the NACFC website at https://www.nacfconference.org/.
Acebilustat is a once-daily oral drug candidate progressing to Phase 3 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including cystic fibrosis (CF). More specifically, an overactive immune response driven by neutrophils results in excessive inflammation in the CF lung. This leads to irreversible damage resulting in excessive morbidity and mortality in CF patients. Acebilustat is designed to modulate the neutrophil driven immune response bringing the inflammation to homeostasis, preventing overactive inflammation from occurring, and thus could be potentially helpful in CF patients. By contrast, pro-resolving agents theoretically tone down inflammation once it is overactive and already contributing to lung damage in patients. Furthermore, unlike immunosuppressive treatments, such as corticosteroids, acebilustat has not demonstrated any evidence of immunosuppression in preclinical studies or in clinical trials in humans, including healthy volunteers and CF patients. Acebilustat is the most advanced therapy in development in the CF anti-inflammatory pipeline.
About Cystic Fibrosis
Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze inflammation and infection of the lungs. This inflammation is primarily mediated by neutrophils. Over time, the amplification of the synergistic cycle of infection and inflammation leads to pulmonary exacerbations that could ultimately lead to lung function decline. Lung inflammation is still the leading cause of morbidity and mortality associated with CF.
Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.
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