POZEN announced positive top-line results of a phase I study of PA32540, a novel coordinated-delivery tablet of enteric-coated aspirin (325mg) and immediate-release omeprazole (40mg). The data from the Co-Rx study suggest that PA32540 given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in significantly better inhibition of ADP-induced platelet aggregation when compared to a current standard of care (81mg of enteric-coated aspirin, enteric-coated omeprazole 40mg and clopidogrel).
“The findings suggest that the dual antiplatelet regimen of clopidogrel plus PA32540, that contains immediate-release omeprazole, results in an approximate 20% improvement in the anti-clotting effects compared to a current clinical standard of care dual antiplatelet regimen,” said John G Fort, chief medical officer, POZEN and co-investigator for the study. “Although the clinical significance of these results is presently unknown, we continue to believe that PA32540 offers a promising potential option for the secondary prevention of heart attacks and strokes in cardiovascular patients who require aspirin therapy, but are at risk for gastric ulcers.”
PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. This investigational product is part of POZEN’s pipeline of integrated aspirin therapies, called the PA product portfolio.
About the Co-Rx study
The Co-Rx study was a phase I, randomised, open-label, two-arm crossover study in which 30 healthy subjects were treated with one of the following: A) PA32540 in the morning plus Plavix (clopidogrel) (300mg) over 10 hours later on day 1, and PA32540 in the morning plus clopidogrel (75mg) 10 hours later on days two through seven; B) enteric-coated aspirin (81mg) plus clopidogrel (300mg) plus Prilosec (enteric-coated omeprazole) (40mg) all in the morning on day 1 followed by enteric-coated aspirin (81mg) plus clopidogrel (75mg) plus enteric-coated omeprazole (40mg) all in the morning on days two through seven. Subjects were first randomised to treatment A or treatment B and then crossed over to the alternate treatment. Each treatment was separated by a 14 day washout period.
The primary endpoint was the percent inhibition of platelet aggregation (IPA) after morning dosing on day seven of each period. In the study, PA32540 in the morning, plus clopidogrel 10 hours later, resulted in a significantly greater IPA than enteric-coated aspirin (81mg) plus enteric-coated omeprazole (40mg) plus clopidogrel all dosed in the morning.
POZEN is creating a pipeline of integrated aspirin therapies, called the PA product portfolio. The products in the PA portfolio are intended to significantly reduce gastrointestinal ulcers and other complications compared to taking aspirin alone.
The first candidate is PA32540. It is a coordinated-delivery tablet combining immediate release omeprazole, a proton pump inhibitor (PPI), layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. POZEN has completed enrolment for the long-term safety study and continues enrolment on the two pivotal studies, targeting a new drug application filing in 2012.
Additionally, POZEN is conducting exploratory work on integrated aspirin therapies for other pain and pain-related conditions.