Celtaxsys, Inc, a clinical stage biotechnology company, announced that the FDA has granted orphan drug designation to its cystic fibrosis treatment drug leukotriene A4 hydrolase inhibitor.
“We are pleased to have received orphan drug designation for CTX-4430 to treat the inflammatory component of cystic fibrosis, a disease that still results in unacceptable levels of morbidity and pre-mature mortality,” said Greg Duncan, President and Chief Executive Officer.
“By down regulating over activated neutrophils and reducing neutrophil elastase in the lungs, we hope to preserve small airway cell structure, reduce lung clogging and to enhance CF patient lung function over time. Celtaxsys has now been granted orphan designation for CTX-4430 in both the US and the EU, geographies in which 90% of CF patients reside. We are currently scaling capital to progress CTX-4430 into a phase 2 trial later this year in CF for treatment of patients 18 years of age and older.”