BERWYN, Pa.--(BUSINESS WIRE)--Complexa Inc. today announced dosing of the first patient in PRIMEx, a Phase 2 clinical trial evaluating the safety and efficacy of two doses of the company’s lead candidate, CXA-10, to treat pulmonary arterial hypertension (PAH). PAH is a rare, progressive disease characterized by high blood pressure in the vessels that carry blood from the right side of the heart to the lungs, which can compromise the normal function of the heart. It impacts approximately 30,000 individuals in the U.S. with nearly 1,000 new cases diagnosed yearly. CXA-10 is the first drug of a novel pharmacological class of oral compounds called nitrated fatty acids (NFAs) in development for the treatment of PAH.
“With CXA-10, we have the opportunity to address the unresolved need in pulmonary arterial hypertension. Currently, approved treatment options primarily target symptoms without appreciable impact on modifying the underlying disease,” said Francisco Salva, President and Chief Executive Officer of Complexa. “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.”
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 study will enroll up to 115 patients who will be randomized into one of three cohorts, placebo, 75 mg or 150 mg of oral CXA-10, given once daily. All study participants will be monitored for safety assessments and pharmacokinetics including a follow-up period after the end of the pre-specified treatment duration. Efficacy endpoints of PRIMEx include the change from baseline of two oral doses of CXA-10 compared to placebo in right ventricular ejection fraction (RVEF) by cardiac MRI, pulmonary vascular resistance (PVR) and six-minute walk distance (6MWD) measurement.
The PRIMEx trial is anticipated to be conducted at approximately 45 clinical trial centers across the United States and Europe. More information about the trial is available at www.clinicaltrials.gov, identifier NCT03449524.
Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by high blood pressure in the arteries that carry blood from the heart to the lungs for unknown reason. PAH occurs in females more than males with onset between the ages of 30 and 60. Although the origin of PAH is unknown, 15 to 20 percent of patients have heritable PAH. Symptoms of PAH include shortness of breath (dyspnea) especially during exercise, chest pressure and fatigue. The disease is often misdiagnosed because the symptoms are vague and may be similar to other heart and lung conditions. As PAH is progressive, it is important to treat the disease so that the high blood pressure does not cause further narrowing of the vessels carrying blood from the heart to the lungs, resulting in the heart muscle to work harder against higher pressures and weaken.
CXA-10 is an oral NFA compound which impacts the fibrotic and inflammatory pathways. CXA-10 acts through key reparative, metabolic and inflammatory pathways, including upregulation of the Nrf2 pathway and inhibition of Nuclear factor-kappa B and Toll-Like Receptor 4 pathways. In addition, CXA-10 increases the expression of heat shock proteins, which act as chaperones during cellular stress, and inhibits xanthine oxidoreductase to reduce oxidative stress. In five Phase 1 clinical trials, CXA-10 demonstrated target engagement at the specific doses being used in Phase 2 and was shown to be tolerable and safe in more than 100 subjects. Importantly, CXA-10 has demonstrated impact on relevant biomarkers of pharmacological action as well as inhibition of key biomarkers of disease-related inflammation and fibrosis.
Complexa Inc. is a patient-focused, science-driven, clinical stage biopharmaceutical company developing a novel class of compounds, nitrated fatty acids (NFAs), for the safe and effective treatment of debilitating fibrotic and inflammatory diseases. NFAs have demonstrated broad potential to be effective therapeutic agents in multiple disease indications in which oxidative stress, inflammation, fibrosis and/or direct tissue toxicity play significant roles. This class of molecules has the potential to be disease-modifying in many disorders, given the broad activity of NFAs. An experienced consortium of investors, including Andera Partners, HBM Healthcare Investments, JAFCO, New Enterprise Associates (NEA) and Pfizer Venture Investments have committed funding to advance a platform of NFA agents across multiple orphan disease indications. Complexa’s lead candidate, CXA-10, is currently in Phase 2 development for focal segmental glomerulosclerosis (FSGS) and pulmonary arterial hypertension (PAH). For more information, visit www.complexarx.com.