Celtaxsys, Inc., a private biopharmaceutical company developing a new class of drugs to treat chronic inflammatory disorders, today announced the initiation of a first-in-human Phase 1 clinical study of CTX-4430, which blocks the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H).
"With first subjects dosed in our Phase 1 study of CTX-4430, Celtaxsys has achieved an important milestone," said Michael Hanley, PhD, Chief Executive Officer of Celtaxsys. "CTX-4430 is a first-in-class, once-daily oral treatment with exciting potential to alleviate inflammation associated with cystic fibrosis and other pulmonary conditions."
The Phase 1 clinical trial CTX-4430-HV-001 is a randomized, double-blind, placebo-controlled, ascending and repeat dose study aimed at evaluating the safety, tolerability and pharmacokinetics (PK) of CTX-4430 oral capsules. The trial is expected to enroll 96 subjects. Study results are expected in the first half of 2013, with the initiation of Phase 2 studies in the first line indication, Cystic Fibrosis, planned to start later in the year.