ARYx Therapeutics Inc. Updates Progress with Tecarfarin EmbraceAC Study
Phase 2/3 Clinical Trial Results To Be Released the Week of 6th July
FREMONT, Calif.--(BUSINESS WIRE)--Jun 16, 2009 - ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced today that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of July 6, 2009. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin 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 tecarfarin.
The raw data, containing both the efficacy and safety results, will now be transferred to independent statisticians who will create the tables and listings according to the previously adopted statistical analysis plan. This plan has been reviewed by the FDA. The results from the study will remain blinded to ARYx until just prior to their public release.
The trial of approximately 600 patients is a randomized, double blind, parallel group, active control study comparing tecarfarin with warfarin in patients who require chronic, oral anticoagulation. All patients in the study were treated for a minimum of six months and required anticoagulation therapy to avoid serious blood clotting resulting from their underlying condition. This includes patients with atrial fibrillation; an implanted prosthetic heart valve; a history of venous thromboembolic disease; 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 has been applied for patients receiving warfarin therapy as those administered tecarfarin. 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 tecarfarin than with warfarin.
For more information, go to http://www.clinicaltrials.gov/ct2/show/NCT00691470.
Tecarfarin (previously 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. Tecarfarin, 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, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYx believes the avoidance of cytochrome P450 metabolism will cause the dosing and response to tecarfarin 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 development: an oral anticoagulant agent for patients at risk for the formation of dangerous blood clots, tecarfarin (previously ATI-5923); an oral anti-arrhythmic agent for the treatment of atrial fibrillation, budiodarone (previously 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 the ARYx Website at www.aryx.com for additional information.
This press release contains forward-looking statements, including, without limitation, statements related to the potential safety and efficacy and further development of tecarfarin, the timing and availability of our clinical results, the initiation of new clinical trials, the ability of a product candidate to be more predictable than currently available therapies regarding dosing and response to treatment, and the ability of a product candidate to avoid the dangers existing in currently available therapies. Words such as “believes,” “estimates,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon our current expectations. Forward-looking statements involve risks and uncertainties. ARYx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that our product candidates may not demonstrate safety and efficacy or lead to regulatory approval, the risk that we may be unable to raise additional capital when needed which would force us to delay, reduce or eliminate product development programs, the risk that any failure or delay in commencing or completing clinical trials for our product candidates could severely harm our business, the risk that third party manufacturers could delay or prevent the clinical development of our product candidates, risk that potential collaborative arrangements will likely place the development of our product candidates outside of our control, the risk that we may have to alter our development and commercialization plans if collaborative relationships are not established for tecarfarin, budiodarone and ATI-7505, the risk that our product candidates may not demonstrate safety and efficacy or lead to regulatory approval, the risk that we may be unable to raise additional capital when needed which would force us to delay, reduce or eliminate product development programs, the risk that any failure or delay in commencing or completing clinical trials for our product candidates could severely harm our business, and the risk that third party manufacturers could delay or prevent the clinical development of our product candidates. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2008, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 and our other filings with the U.S. Securities and Exchange Commission. ARYx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Contact: ARYx Therapeutics, Inc. David Nagler, 510-585-2200 ext. 211 Vice President Corporate Affairs firstname.lastname@example.org
Posted: June 2009