ARYx Reports Data For Phase 2/3 Tecarfarin Trial

ARYx has announced the results from phase 2/3 clinical trial, EmbraceAC, comparing anticoagulant agent tecarfarin (ATI-5923) with oral anticoagulant warfarin.

In the trial, tecarfarin demonstrated efficacy essentially the same as in earlier phase 2 studies, but did not achieve the primary endpoint of superiority over warfarin, as measured by time in therapeutic range (TTR).

The patients in the trial who were administered tecarfarin stayed within the target therapeutic range 74.0% of the time treated, as compared to those receiving warfarin who stayed within the target therapeutic range 73.2% of the time (p=0.506). The result for the warfarin group was unexpected, based upon the extensive history of prior studies and published literature for the drug. Tecarfarin appeared to be well tolerated by the patients in the phase 2/3 clinical trial.

Paul Goddard, Cairman and CEO of ARYx, said: While we are obviously disappointed at the outcome of this trial, tecarfarin achieved the results we anticipated based upon two earlier Phase 2 studies. We continue to demonstrate a time within therapeutic range of INR that remains consistent from trial to trial, whether dosing decisions are made by treating physicians or through a centralized dosing control. In contrast, warfarin patients did much better than we had reason to expect and as a result we did not achieve statistical significance. This appears to be due in no small part to the central dose control center that we established for the trial, and to the ability of the center to anticipate the potential daily pitfalls of warfarin use.

Such oversight for warfarin control dosing was necessary for our doubleblind trial even though it’s not seen in normal clinical practice. An initial analysis of the data reinforces the importance of comparing normal tecarfarin administration to typical warfarin practice in a so-called real world setting. There are still a lot of data to be analyzed from this trial. Once we have fully analyzed both the efficacy and safety results, we will continue our on-going partnership discussions with several large pharmaceutical companies to determine the best path forward in the future development of tecarfarin. Of course, as we have previously stated, we also remain focused on the licensing of budiodarone and ATI-7505, he added.