Pozen rockets on positive Ph III trial results with aspirin combo drug

USA-based Pozen (Nasdaq: POZN) saw its shares leap 9% to $5.24 on Thursday morning, having risen nearly 20% to a six-month high of $5.73 earlier in the session, after the company revealed that aspirin combination drug helps prevent gastric ulcers in aspirin users and that it plans to file for US marketing approval in the third quarter of this year.

Pozen announced positive top-line results from two pivotal Phase III clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325mg). Omeprazole is the active ingredient of AstraZeneca’s anti-ulcerant Losec.

The two Phase III pivotal trials were randomized, double-blind, multicenter studies in which a total of 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325mg once daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once daily. The primary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 versus 32 mg enteric-coated aspirin over six months, was met in both studies.