Key Developments For ARYx Therapeutics, Inc.
ARYx Therapeutics, Inc. (ARYX.O) (Consolidated Issue listed on NASDAQ Global Market)
ARYx Therapeutics, Inc. Announces Results From Phase 2b Study On Atrial Fibrillation Agent
ARYx Therapeutics, Inc. 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 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 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 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.
ARYx Therapeutics, Inc. Announces Reduction In Personnel; To Record Charge In Q4 2009
ARYx Therapeutics, Inc. announced that staffing changes impacted functions throughout ARYx and included a reduction in personnel from 73 employees to 56 employees. ARYx expects to record a charge of less than $500,000 in the fourth quarter of 2009 related to this reduction in personnel.
ARYx Therapeutics, Inc. Secures $35 Million Committed Equity Financing Facility
ARYx Therapeutics, Inc. announced that it has secured a committed equity financing facility under which it may sell up to $35 million of shares of its common stock to Commerce Court Small Cap Value Fund, Ltd. over a 24 month period. The maximum number of shares that can be sold by ARYx is specified in the agreement. ARYx is not obligated to utilize any of the $35 million facility and remains free to enter into and consummate other equity and debt financing transactions.
ARYx Therapeutics, Inc. Announces Results Of Phase 2/3 Clinical Trial On Anticoagulant Agent Tecarfarin
ARYx Therapeutics, Inc. announced that results from its Phase 2/3 clinical trial, EmbraceAC, comparing its novel anticoagulant agent tecarfarin (previously ATI-5923) with the leading oral anticoagulant warfarin. In this trial, tecarfarin demonstrated efficacy essentially the same as in earlier Phase II 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.
ARYx Therapeutics, Inc. Provides Additional Data on Atrial Fibrillation Clinical Trial on ATI-2042
ARYx Therapeutics, Inc. announced further results from a Phase 2b clinical trial testing the safety and efficacy of its oral anti-arrhythmic therapy, ATI-2042, in patients with atrial fibrillation. This follows the December 18, 2008 press release reporting that ATI-2042 reached statistical significance at its primary end point in the two highest of three doses tested. Those results are now reinforced by these additional findings indicating, in part, that patients in the study quickly returned to their pre-treatment level of atrial fibrillation once the treatment ended. The complete safety results from this study are still not finalized and are expected by the end of March 2009.
