POZEN Inc. (POZN: Quote) announced Thursday that its investigational drug, PA32540, achieved its primary endpoint of a significant reduction in the cumulative incidence of gastric ulcers in two pivotal late-stage trials.
PA32540 is a combination of enteric-coated 325 mg of Aspirin and 40 mg immediate-release omeprazole (sold under the brand name Prilosec). PA32540 is being investigated for secondary prevention of cardiovascular disease in patients at risk for Aspirin-induced ulcers.
Aspirin is considered the gold standard for secondary prevention of cardiovascular disease. According to reports, more than 50 million U.S. adults take Aspirin regularly for long-term prevention against heart attack and stroke.
Since there are concerns that Aspirin's undesirable side effects, mainly bleeding ulcers, might outweigh the benefits in many healthy or older people, there is an urgent need for a safer form of Aspirin, and POZEN's PA32540 is designed to address this unmet need.
The two pivotal phase III studies enrolled a total of 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325 mg once daily for at least three months for secondary prevention of cardiovascular events , and they were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once daily.
The primary endpoint of the trial was a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 against 325 mg enteric-coated aspirin over six months According to the trial results reported today, the main goal was met in both studies. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325 mg enteric-coated aspirin.
PA32540 has already completed a one-year, long-term safety study, and the top-line results of the study announced last October, supported the safety profile that was expected for PA32540. The submission of New Drug Application for PA32540 is planned for the third quarter.
POZEN is also currently seeking one or more strategic partners to maximize the global potential of PA32540, and is in discussions with potential partners with the assistance of Keelin Reeds Partners LLC.
POZN closed Wednesday's trading at $4.80. In pre-market trading Thursday, the stock is up over 14% at $5.49.
by RTT Staff Writer
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