Celtaxsys planning Phase III program for CF candidate

Celtaxsys Inc. (Atlanta, Ga.) said it hopes to start Phase III testing in 2H19 evaluating acebilustat (CTX-4430) to treat cystic fibrosis after reporting data from the Phase II EMPIRE-CF trial of the candidate in the indication.

While the leukotriene A4 hydrolase (LTA4H) inhibitor missed the trial's primary efficacy endpoint of improving percent predicted forced expiratory volume in 1 second (FEV1) from baseline over 48 weeks vs. placebo, the company said acebilustat led to "clinically meaningful" improvements in pulmonary exacerbations...