ARYx Completes Enrollment in Phase II/III Anticoagulation Comparison Study
ARYx Therapeutics, a biopharmaceutical company, has completed enrollment in EmbraceAC, a Phase II/III double-blind clinical trial comparing its oral anticoagulation therapy, ATI-5923, against the leading anticoagulant agent, warfarin.
The purpose of the trial 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 as measured by international normalized ratio (INR). Based upon recent interactions with the FDA, ARYx believes this trial could be positioned as one of the required registration studies for ATI-5923.
The trial has enrolled approximately 600 patients at 48 clinical study sites in the US. 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 who enter this study will be treated for a minimum of six months and require anticoagulation therapy to avoid serious blood clotting resulting from any of their underlying conditions.
The same target therapeutic range of INR is being applied for patients receiving warfarin therapy as those 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.
Paul Goddard, chairman and CEO of ARYx, said: “By completing enrollment in EmbraceAC now, we are assured of delivering the results by our milestone date of the end of the first half of 2009.”