ARYx Therapeutics Commences Phase 2/3 Clinical Trial on Oral Anticoagulant Agent ATI-5923
News Jun 19, 2008
ARYx Therapeutics Inc. has announced it has commenced enrollment in a Phase 2/3 clinical trial comparing its oral anticoagulation therapy, ATI-5923, against warfarin.
The purpose of the trial, named EmbraceAC, is to evaluate whether ATI-5923 is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation.
Based upon recent interactions with the United States Food and Drug Administration (FDA), ARYx Therapeutics believes this trial could be positioned as one of the required registration studies for ATI-5923. Results will be announced at the end of the second quarter of 2009.
The trial is expected to enroll approximately 600 patients at over fifty clinical study sites in the United States. It is a randomized, double-blind, parallel group, active control study comparing ATI-5923 with warfarin in patients who require chronic, oral anticoagulation.
The patients will be treated for a minimum of six months. Participants will require anticoagulation therapy to avoid serious blood clotting resulting from any of the following conditions: atrial fibrillation; existence of a prosthetic heart valve; a history of venous thromboembolic disease (DVT/PE); a history of myocardial infarction or cardiomyopathy; or another indication for which they are currently receiving chronic warfarin therapy.
The level of anticoagulation achieved will be measured by the standard method applied to warfarin therapy called the International Normalization Ratio (INR).
The target therapeutic range for warfarin therapy will also be applied to patients administered ATI-5923. The primary endpoint of the trial is to demonstrate that patients are maintained within the target INR range a higher percentage of the time when treated with ATI-5923 than with warfarin.