POZEN (POZN) PA65020 Phase I Shows Risk Reduction in Upper Gastrodudenal Damage
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POZEN Inc. (NASDAQ: POZN) announced today the results of a Phase I study that showed a novel, investigational combination of enteric-coated aspirin (EC-ASA) and immediate-release omeprazole known as PA65020, is associated with a significantly decreased risk of GI mucosal damage compared to analgesic doses (650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in healthy adults treated for one month.
The randomized, double-blind study highlighted that the majority of patients taking over-the-counter EC-ASA experienced significant gastroduodenal damage. The data were presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting today in San Diego, CA. ACG presented the study with a Presidential Award for winning science.
The study examined 20 healthy adults with normal endoscopy, defined as a Grade 0 Lanza score at baseline. Dosing schedules were as follows: PA65020 was administered in two tablets (fixed dose combination of EC-ASA 325 mg and IR omeprazole 20 mg, and EC-ASA 325 mg) twice daily; EC-ASA 650 mg was administered as two 325 mg tablets twice daily. Following 28 days of therapy, 15% of the PA65020 treatment group versus 85% of the EC-ASA treatment group had Grade 3 or 4 Lanza scores (P<0.001), the study's primary endpoint. In addition, 65% of subjects in the PA65020 group had Grade 0 Lanza scores, meaning no visible gastroduodenal lesions, versus 0% of subjects in the EC-ASA group. An assessment of gastric and/or duodenal ulcers showed that no patients in the PA65020 treatment group versus 40% of those in the EC-ASA treatment group (P=0.003) had evidence of these complications at day 28. No serious adverse events were reported and there were no withdrawals due to adverse events.
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