Results Of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk Of Upper Gastrointestinal Damage In Healthy Adults

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Oct 2009 - 6:00 PDT

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POZEN Inc. (NASDAQ: POZN) announced 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.

"These findings are encouraging for the millions of people who require analgesic doses of aspirin but are at risk for upper GI damage as a result of this treatment," said Dr. John Fort, Chief Medical Officer. "More than five billion units of aspirin in all of its forms are sold in the U.S. each year. Upper GI toxicity is a common complication of aspirin therapy. Even modified-release aspirin formulations do not significantly lower the risk of GI events."

About the Study

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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Pozen