Results From Phase 2b Study on Atrial Fibrillation Agent Reviewed at American Heart Association
FREMONT, Calif., Nov 18, 2009 (BUSINESS WIRE) -- ARYx Therapeutics, Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced that a review of the results of the Phase 2b clinical trial, PASCAL, testing the efficacy and safety of ARYx's compound for the treatment of atrial fibrillation, budiodarone, was presented today at the American Heart Association meeting in Orlando, Florida. The primary efficacy and safety results from PASCAL were announced in early 2009, demonstrating that budiodarone significantly reduces atrial fibrillation (AF) burden, or the time spent in AF, in patients suffering from paroxysmal AF. The details reviewed today focused on budiodarone's rapid on-set of action, with a significant reduction in patients' AF burden occurring within the first thirty days of treatment in two of three doses tested. In addition, the effect of budiodarone was sustained over the course of three months of treatment. Budiodarone is a novel oral antiarrythmic therapy modeled on the efficacy of amiodarone, the gold standard treatment for atrial fibrillation.
"The primary efficacy results from the PASCAL study clearly demonstrate evidence of budiodarone's effect in significantly reducing the time spent in atrial fibrillation by patients suffering from paroxysmal AF," stated Dr. Michael Ezekowitz of The Lankenau Institute for Medical Research and who chaired the AHA session at which the PASCAL data was reviewed. "We further observe that the reduction in AF burden occurred rapidly, with a highly significant reduction in AF burden occurring in the first month of treatment in the 400mg BID and 600mg BID dose groups. These promising results, if sustained in subsequent Phase 3 clinical studies, together with the 75% reduction in AF burden previously demonstrated, create a promising profile for this drug."
The primary efficacy results from the Phase 2b PASCAL clinical trial were announced in December 2008 and the safety results were announced in January 2009 (see press releases dated December 18, 2008 and January 12, 2009). The primary efficacy results showed that budiodarone significantly reduced patients' AF burden in two doses tested, 400 mg BID (p=0.015) and 600 mg BID (p=0.005) over the entire three-month treatment period when compared to each patient's baseline AF burden measured when budiodarone treatment began. The atrial fibrillation burden in these two treatment groups was reduced from baseline by 54% and 75%, respectively. Although the 200 mg BID dose decreased atrial fibrillation burden by 10%, this did not reach statistical significance. Budiodarone treated patients returned to essentially their baseline AF burden within 30 days following treatment.
The efficacy analysis also included a month-by-month assessment of the patients' burden. The reduction in atrial fibrillation burden was statistically significant in each of the 3 months of treatment in both the 400 mg BID group and the 600 mg BID group. By significantly reducing AF burden within the first month of treatment, budiodarone appears to have a rapid on-set of action. The maximal effect of the drug was seen in the third month on 600 mg BID where the percentage reduction was 83% (p=0.009).
Budiodarone is an oral anti-arrhythmic therapy modeled on the efficacy of amiodarone, the "gold standard" anti-arrhythmic therapy for the treatment of atrial fibrillation (AF). Approximately 6.4 million people in the United States, Europe and Japan are diagnosed with AF. No other therapy has demonstrated the efficacy of amiodarone in the treatment of persistent and paroxysmal AF and its avoidance of dangerous proarrhythmic effects. However, amiodarone is dependent upon cytochrome P450 enzymes for metabolism and this slow clearance pathway leads to substantial organ accumulation which is believed to be responsible for its potentially life-threatening and toxic side effects. Through its metabolism by an alternate and high capacity pathway, budiodarone is designed to maintain amiodarone's unique, balanced pharmacological effect on various ion channels in the heart while avoiding its very slow elimination and resulting side effects.
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 anti-arrhythmic agent for the treatment of atrial fibrillation, budiodarone (ATI-2042); a prokinetic agent for the treatment of various gastrointestinal disorders, ATI-7505; an oral anticoagulant agent for patients at risk for the formation of dangerous blood clots, tecarfarin (ATI-5923); 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 efficacy of budiodarone. Words such as "may," "suggests" 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 ARYx will need substantial additional funding and may be unable to raise additional capital when needed which would force ARYx to limit or cease its operations and related product development programs, the risk that collaborative arrangements will likely place the development of ARYx's product candidates outside of its control, the risk that ARYx depends on collaborative arrangements to complete the development and commercialization of each of its product candidates and ARYx may have to alter its development and commercialization plans if collaborative relationships are not established for tecarfarin, budiodarone and ATI-7505, the risk that ARYx's product candidates may not demonstrate safety and efficacy or lead to regulatory approval, the risk that any failure or delay in commencing or completing clinical trials for its product candidates could severely harm ARYx's business, and the risk that third party manufacturers could delay or prevent the clinical development of ARYx's product candidates. These and other risk factors are discussed under "Risk Factors" and elsewhere in ARYx's Annual Report on Form 10-K for the year ended December 31, 2008, in ARYx's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 and ARYx's 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.
SOURCE: ARYx Therapeutics, Inc.
ARYx Therapeutics, Inc.
David Nagler, 510-585-2200 x. 211
Vice President Corporate Affairs
Posted: November 2009