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12:00 AM
Jul 13, 2009
 |  BioCentury  |  Product Development

The real world must wait

There some indications where it is hard to get new drugs approved, despite the obvious need, because patients on traditional treatments do so much better in the rigorous setting of a clinical trial than they ever do in the real world. ARYx Therapeutics Inc. ran into precisely this problem last week, as its tecarfarin failed to show superiority to warfarin in the double-blind Phase II/III EmbraceAC trial.

When ARYx met with FDA in late 2007 to plan its registration strategy, the agency said the company would need to perform head-to-head trials of tecarfarin against warfarin both in a real-world setting and in a strictly controlled, double-blind trial. The company decided that if it could only afford to do one trial, it wanted it to be well controlled, according to David Nagler, VP of corporate affairs.

That study failed last week, but the company still believes tecarfarin will outperform warfarin in the real world. However, because ARYx does not have the cash to complete clinical development, the anticoagulant's fate will depend on whether potential partners agree.

Warfarin has been used for more than 50 years, but maintaining a stable dose can be difficult. Metabolism and clearance of the drug are affected by variant alleles of two genes, cytochrome P450 family 2 subfamily C polypeptide 9 (CYP2C9) and vitamin K epoxide reductase complex subunit 1 (VKORC1), as well factors like concomitant medications. This can result in over- or under-anticoagulation, either of which can...

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