What is PAH?
Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by high pressure (hypertension) in the arteries of the lungs (pulmonary artery). Symptoms of PAH include shortness of breath (dyspnea), especially during exercise, chest pressure and fatigue. Current treatment options primarily reduce the symptoms associated with the high pressure by dilating the vessels that carry blood from the right side of the heart to the lungs. The ability to modify the underlying disease is an important treatment goal for the next generation of products. CXA-10, through its anti-inflammatory, antifibrotic and pro-reparative action could modify the PAH disease process.
What is the PRIMEx Clinical Trial?
PRIMEx is a Phase 2 clinical study testing the safety and effectiveness of an investigational drug called CXA-10 designed to treat patients with PAH who are on stable background therapy. Throughout the study, researchers will evaluate how different doses of CXA-10 affect the patient’s heart function, exercise tolerance, and quality of life, as well as concentration of CXA-10 in the blood. The study is taking place at approximately 50 clinical sites across the United States and the United Kingdom. The study will enroll up to 115 patients who have been diagnosed with PAH.
Am I eligible to participate in the PRIMEx Clinical Trial?
The PRIMEx study is open to individuals who meet the following criteria:*
Women and men between the ages of 18 and 80
Have been diagnosed with PAH (WHO Group 1)
Meet hemodynamic criteria by means of a right heart catheterization
Meet pulmonary function test parameters and 6-minute walk distance (6MWD)
Receiving treatment with no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (≥3 months)
*Additional criteria will be used to determine participation
Before enrolling, your doctor will go over all of the details of the trial, including the possible risks and benefits.
Patients who complete the PRIMEx study may be eligible to receive study medication for a follow-up 6-month open-label extension study.
For more information about PRIMEx, visit clinicaltrials.gov (NCT 03449524).
What is a Clinical Trial?
Researchers conduct clinical studies to help discover new and better ways to treat and prevent specific diseases. Studies are possible because of patients like you. Before new treatments can be made publicly available, the U.S. Food and Drug Administration (FDA) requires that they are studied in clinical trials. Choosing to join a clinical study is an important personal decision. There are possible benefits and risks associated with clinical studies. Talk with your doctor and family members or friends before deciding to enroll. It is your decision whether to participate and you can choose to stop taking part in.