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RxTrials Institute Drug Pipeline Alert
> Atrial Fibrillation Drug Meets Primary Efficacy Endpoint in Trial
RxTrials Institute Drug Pipeline Alert
Dec. 24, 2008
| Vol.
6 No.
52
Atrial Fibrillation Drug Meets Primary Efficacy Endpoint in Trial
ARYx Therapeutics’ oral arrhythmia therapy ATI-2042 met the primary endpoint in a Phase IIb clinical trial, reducing the incidence of atrial fibrillation, according to the biotech company.
The effects of the drug were statistically significant at the two highest doses of the three tested, replicating the findings of an earlier Phase II study that also was conducted in patients with paroxysmal atrial fibrillation, a form of arrhythmia. The company is seeking a partner to conduct a Phase III trial of the drug, submit an NDA and commercialize it, David Nagler, vice president for corporate affairs, said. There is no timeline set for the Phase III trial or the NDA submission, but ARYx expects to complete an agreement with a partner in the first half of next year, Nagler added. |
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