Celtaxsys Secures Private Financing to Advance Acebilustat Phase 3 Cystic Fibrosis (CF) Program Preparatory Activities

ATLANTA, Jan. 04, 2018 (GLOBE NEWSWIRE) -- Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for rare inflammatory diseases, today announced the successful completion of a Series E financing led by Invus. Additional investors in the financing include Domain Associates, Lumira Capital, Masters Capital Management, RMI Partners and the Georgia Research Alliance Venture Fund.  In conjunction with the financing, Khalil Barrage, Managing Director at Invus, will join Celtaxsys’ board of directors.

Celtaxsys’ lead candidate, once-daily oral acebilustat, is currently in Phase 2 clinical testing to assess the drug’s safety and efficacy in preserving lung function in cystic fibrosis (CF) patients over the course of 48 weeks of treatment. This fully enrolled Phase 2b trial has been designed and implemented with the scientific and financial support of the Cystic Fibrosis Foundation.  Top line results from this trial are expected in mid-2018.  Acebilustat has been granted Orphan Drug Designation for the treatment of CF in both the United States and the European Union. The Series E proceeds will support acceleration of Phase 3 clinical and manufacturing preparatory activities.

“This financing, led by top-tier biotech investors, speaks to the investment community’s support for developing innovative anti-inflammatory medicines for CF patients. Two-week treatment with acebilustat has demonstrated reduction in sputum neutrophils, neutrophil elastase and DNA, and serum CRP in CF patients in a Phase 1b study.  We believe the anti-inflammatory activity of acebilustat has the potential to preserve lung function and reduce pulmonary exacerbations in CF patients when given concomitantly with standard of care, irrespective of patient-specific CF gene mutation,” said Greg Duncan, President and CEO of Celtaxsys.

“Although new therapies that correct CFTR have markedly improved the outlook for patients with CF over the past few years, the effects of chronic inflammation in the lungs are still an important factor in the morbidity and mortality in CF patients.  An effective anti-inflammatory therapy for CF patients is a significant unmet medical need,” said Professor Stuart Elborn CBE, Director of the Adult CF Center at Royal Brompton Hospital and Imperial College, London.  “Acebilustat is an advanced stage development candidate in the CF anti-inflammatory pipeline and if proved to be safe and efficacious in current and future development, has the potential to be a component of foundational therapy for CF patients,” added Dr Elborn.

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 persistent bacterial infection of the lungs.  Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity.  Excessive production of a neutrophil by product, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient.  Paradoxically, excessive production of a neutrophil elastase can also lead to reduced bacterial clearance.  Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations.  Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority.  For more information about CF, visit: www.cff.org. 

About acebilustat: Acebilustat is a once-daily oral drug candidate currently in Phase 2 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, Non-CF Bronchiectasis, Pulmonary Hypertension, Multiple Sclerosis, Inflammatory Bowel Disease, Non-alcoholic steatohepatitis (NASH) and a variety of dermatologic diseases including Bullous Dermatoses.

About Celtaxsys: 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.