June 5, 2015 in News from Our Companies

CYSTIC FIBROSIS FOUNDATION AWARDS $5 MILLION TO CELTAXSYS

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Screen Shot 2015-02-06 at 3.40.05 PMThe Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) awarded $5 million to Celtaxsys, a clinical stage drug development firm focused on advancing care for patients suffering from inflammatory diseases, including those with rare and orphan inflammatory ailments.

CFFT is the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation; Celtaxsys is an ATDC Graduate Company. The development award will help support a Phase 2 clinical trial of the Celtaxsys’ lead development candidate, a once daily, oral anti-inflammatory drug CTX-4430 in adults with cystic fibrosis. The drug is a selective inhibitor of Leukotriene A4 Hydrolase that targets re-balancing of a patient’s over activated inflammatory response without increasing susceptibility to infection. CTX-4430 has been granted orphan status for CF in both the United States and the European Union.

“We are grateful for the support of CFFT and the many leading researchers in cystic fibrosis who have helped us design a trial to assess the benefits of chronic anti-inflammatory therapy in CF patients,” Celtaxsys CEO Greg Duncan said in a statement. “Our Phase 1 CTX-4430 studies, including the study in CF patients, demonstrated that CTX-4430 is well tolerated. Importantly, in only two weeks in CF patients, CTX-4430 demonstrated positive results on well-established CF biomarkers, including encouraging reductions in sputum neutrophils, one of the primary “bad actors” in the CF lung that clogs the airways of CF patients.”

Cystic fibrosis is a life-threatening disease that affects the lung and digestive system. It affects about 70,000 patients worldwide. The disease is caused by mutations in the cystic fibrosis transmembrane conductance regulator gene, which causes the body to accumulate excessive levels of unusually thick mucus in the lungs. This excessive sticky mucus in the lungs is a site for infections that can require hospitalization.

Celtaxsys will submit its Phase 2 clinical trial protocol for the treatment of CF with CTX-4430 to the U.S. Food and Drug Administration (“FDA”) this quarter and anticipates beginning this study in the second half of 2015, pending FDA approval of the protocol.




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