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DewDiligence

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Re: DewDiligence post# 63621

Monday, 11/03/2008 4:47:24 PM

Monday, November 03, 2008 4:47:24 PM

Post# of 252588
ARYX Completes Enrollment in Phase-2/3 Trial of ATI-5923 vs. Warfarin

[ATI-5923, if it works as advertised, will be able to replace warfarin in any setting where warfarin is currently used and will have fewer drug interactions. However, the question is whether a “better warfarin” is really a compelling idea from a business standpoint. ARYX’s improvements will not obviate the need for close monitoring, which is a drawback of warfarin compared to such oral anticoagulants as Pradaxa and Xarelto.

Results of this phase-2/3 study are expected in mid 2009; the trial does not have an SPA, so it’s a near certainty that at least one more phase-3 study will be needed for FDA approval.]

http://biz.yahoo.com/bw/081103/20081103005554.html

›Monday November 3, 7:00 am ET

FREMONT, Calif.--(BUSINESS WIRE)--ARYx Therapeutics Inc. (NASDAQ: ARYX ), a biopharmaceutical company, today announced it has completed enrollment in EmbraceAC, a Phase 2/3 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 INR (International Normalized Ratio). Based upon recent interactions with the U.S. Food and Drug Administration (FDA), ARYx believes this trial could be positioned as one of the required registration studies for ATI-5923 [in other words, there is no SPA for this trial].

“We are very pleased with the rapid enrollment into this clinical trial,” said Dr. Paul Goddard, chairman and chief executive officer of ARYx. “The investigators at each of our sites have displayed a real commitment to this trial designed to demonstrate whether ATI-5923 is superior to warfarin in maintaining the therapeutically important level of INR. 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.”

The trial has enrolled approximately 600 patients at 48 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 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. This includes patients with atrial fibrillation; an implanted 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 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. In a study conducted by Jones et al. (Heart 2005;91;472-477), it was determined that the risk of mortality, ischemic stroke, and thromboembolic events increases with reduced time in therapeutic INR range after adjustment for age, sex, and baseline morbidity. A 10% decrease in time in therapeutic INR range was associated with a 29% increase in mortality risk (odds ratio 1.29, p < 0.001).

For more information, go to http://www.clinicaltrials.gov/ct2/show/NCT00691470.

About ATI-5923

ATI-5923 is modeled on the drug warfarin as an oral anticoagulation therapy for patients who are in danger of forming life-threatening blood clots as a result of atrial fibrillation, prosthetic heart valve replacement or venous thromboembolism. There are at least an estimated 3.5 million patients requiring anticoagulation therapy in the United States alone. Patients with implanted mechanical heart valves are also amongst those requiring anticoagulation therapy. ATI-5923, like warfarin, is a selective inhibitor of VKOR, or vitamin K epoxide reductase enzyme, and has the same mechanism of anticoagulation action as warfarin. Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, ATI-5923 was designed to avoid drug-drug interactions through its alternative metabolic pathway. We believe the avoidance of cytochrome P450 metabolism will cause the dosing and response to ATI-5923 to be more predictable than with warfarin, avoiding the dangers of over-or-under therapeutic anticoagulation long associated with that therapy.

About ARYx Therapeutics, Inc.

ARYx Therapeutics is a biopharmaceutical company focused on developing a portfolio of internally discovered products designed to eliminate known safety issues associated with well-established, commercially successful drugs. ARYx uses its RetroMetabolic Drug Design technology to design structurally unique molecules that retain the efficacy of these original drugs but are metabolized through a potentially safer pathway to avoid specific adverse side effects associated with these compounds. ARYx currently has four products in clinical trials: an oral anticoagulant agent for patients at risk for the formation of dangerous blood clots, ATI-5923; an oral anti-arrhythmic agent for the treatment of atrial fibrillation, ATI-2042; a prokinetic agent for the treatment of various gastrointestinal disorders, ATI-7505; and, an agent for the treatment of schizophrenia and other psychiatric disorders, ATI-9242. Please visit our web site at www.aryx.com for additional information.‹

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