ARYx Therapeutics (ARYX) Whacked After Blood Clot Treatment Fails To Hit Primary Endpoint

July 8, 2009 8:09 AM EDT

ARYx Therapeutics, Inc. (NASDAQ: ARYX) is getting slammed in pre-open trading after announcing that a trial of anticoagulant agent tecarfarin did not achieve the primary endpoint of superiority over leading oral anticoagulant warfarin.

Shares are down over 50% this AM.

Late last night, ARYx Therapeutics saidn in a Phase 2/3 clinical trial, EmbraceAC, comparing its novel anticoagulant agent tecarfarin (previously ATI-5923) with the leading oral anticoagulant warfarin 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). This was due to the virtually unprecedented performance of warfarin in this trial. Using the International Normalized Ratio (INR), which is the standard measure of anticoagulation to evaluate 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 patients 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 this Phase 2/3 clinical trial.

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