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news.ARYx Therapeutics, a biopharmaceutical company, has announced successful top-line efficacy results from a Phase IIb clinical trial testing the safety and efficacy of its oral anti-arrhythmic therapy, ATI-2042, in patients with atrial fibrillation.
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By achieving statistical significance at the two highest doses of the three tested, the results essentially mirrored the findings of an earlier Phase II study also conducted in paroxysmal atrial fibrillation patients.
The primary efficacy analysis was the percent change in the atrial fibrillation burden from baseline to the whole 12-week treatment period in the mITT1 population. The primary statistical efficacy analysis2 showed significance for ATI-2042 at the 400mg (p=0.015) and 600mg (p=0.005) doses. The atrial fibrillation burden in these two treatment groups was reduced from baseline by 54% and 75%, respectively.
Although the 200mg BID dose decreased atrial fibrillation burden by 10%, this did not reach statistical significance. The overall dose response effect was both robust and linear with a p=0.0001. Randomization was balanced across all four treatment groups, the company said.
The primary efficacy analysis also included a month-by-month assessment of the patients’ burden. The reduction in atrial fibrillation burden was statistically significant in each of the three months of treatment in both the 400mg BID group and the 600mg BID group. The maximal effect of the drug was seen in the third month on 600mg BID where the percentage reduction was 83% (p=0.009).
The benefit of ATI-2042 on the larger ITT3 population in reducing atrial fibrillation burden was also highly significant. The percentage reduction in atrial fibrillation burden for the 400mg BID group was 54% (p=0.013) and for the 600mg BID group it was 74% (p=0.001). Complete results from this study are expected in the first quarter of 2009.
Pascal Druzgala, senior vice president and chief scientific officer of ARYx, said: “It is really gratifying to see that as the dose and duration of treatment of ATI-2042 was increased, we see that the dramatic effect of the drug in reducing atrial fibrillation burden becomes even more pronounced.”