ARYx reports encouraging results from cardiac safety study

The overall results of a Thorough QT (TQT) study designed to demonstrate whether electrocardiographic effects are seen at therapeutic and supra therapeutic doses and conducted under a collaboration agreement with Procter & Gamble Pharmaceuticals (P&G) were negative, supporting the favorable cardiac safety profile of the agent. ATI-7505 is a prokinetic agent in Phase II clinical trials for chronic constipation and functional dyspepsia.

The study, which included 250 subjects of which 78 were female, was a single-center, randomized, double-blind, placebo-controlled, four-arm, parallel-group study of two doses of ATI-7505, a therapeutic dose of 40mg every six hours and supratherapeutic dose of 200mg every six hours, in healthy male and female volunteer subjects.

When the data from all study participants were analyzed, the placebo-corrected QTc mean change from baseline (using the individual correction method for heart rate, or QTcI) for the therapeutic and supratherapeutic doses of ATI-7505 were 1.5 and 3.1 milliseconds, respectively, clearly making the results negative.

An exploratory analysis of the QTc interval data collected from female subjects in the study showed higher QTc increases in both the control drug moxifloxacin and ATI-7505 groups than were observed in the male subjects. However, a further standard analysis of this observation demonstrated that this effect is likely due to certain elements in the conduct of the study rather than a true drug effect.

ARYx expects to submit the results of the complete TQT study to the FDA and believes that these results, along with continued positive clinical and preclinical data, will allow moving ATI-7505 into late-stage development.