The PRIMEx study (NCT03449524) was planned to evaluate the safety, efficacy, and overall stability and distribution in the body of two doses of CXA-10 in adults with PAH while on stable background therapy.
The trial is expected to enroll up to 115 participants across 45 study centers in the United States and Europe. For more information about locations and contacts, visit the trial site.
Patients will be randomized to receive once-daily oral 75 mg or 150 mg of CXA-10, or placebo, for approximately three months.
During this period, researchers will evaluate changes in pulmonary vascular resistance and right ventricle function between CXA-10 and placebo groups. They will also evaluate changes in physical resistance through the six-minute walk distance (6MWD) test.
“We are pleased to advance CXA-10 and continue clinical evaluation of this exciting compound, which has the potential to be a novel first-in-class treatment for patients living with PAH,” Francisco Salva, president and CEO of Complexa, said in a press release.
CXA-10 belongs to a new class of pharmacological compounds called nitrated fatty acids (NFAs). It works by regulating critical cellular signals, including Nrf2, NF-kB, and TLR4 pathways, involved in reparative, metabolic, and inflammatory mechanisms.
Preclinical studies have demonstrated that CXA-10 can increase levels of the anti-inflammatory protein Nrf2, while inhibiting the inflammatory signaling molecule NF-kB. CXA-10 can also modulate the production of heat shock proteins that can help reduce oxidative stress.
Results from previous Phase 1 clinical studies have provided evidence of CXA-10’s targeted activity; Phase 2 trial data have demonstrated that this investigational therapy was safe and well-tolerated in more than 100 subjects.
Importantly, these studies have shown that CXA-10 has a positive effect on several key biomarkers associated with inflammation and fibrosis.
“Currently, approved [PAH] treatment options primarily target symptoms without appreciable impact on modifying the underlying disease,” Salva said. “With CXA-10, we have the opportunity to address the unresolved need in PAH.”
The company is also developing CXA-10 as a treatment for the kidney disease focal segmental glomerulosclerosis (FSGS).