News Brief: October 4, 2019
Complexa Receives Orphan Drug Designation from the FDA for CXA-10
in Pulmonary Arterial Hypertension
The Company’s lead candidate, CXA-10, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). CXA-10 is an oral nitrated fatty acid compound being evaluated in the Phase 2 PRIMEx clinical trial for the treatment of PAH.
“Receiving orphan drug designation for CXA-10 is another important milestone for Complexa as we advance our pipeline to treat debilitating fibrotic and inflammatory diseases in patients who currently have limited or no treatment options,” said Theodore Danoff, MD, PhD, Chief Medical Officer of Complexa. “We are pleased with the progress we are making in the clinic and believe that CXA-10 has the potential to be a novel first-in-class treatment for patients living with PAH. We look forward to taking advantage of the opportunities that orphan designation provides in order to bring this potential new treatment option to patients as quickly as possible.”
The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation allows for Complexa to qualify for a number of incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trials, and exemption from FDA application fees.
PRIMEx is a Phase 2, multicenter, double-blind, placebo-controlled clinical trial evaluating the safety, efficacy and pharmacokinetics of two doses of oral CXA-10 in patients 18 to 80 years of age with PAH while on stable background therapy. The trial is being conducted at approximately 50 clinical sites across the United States and the United Kingdom and will enroll up to 115 patients who have been diagnosed with PAH. More information about the trial is available at www.clinicaltrials.gov, identifier NCT03449524.