Key Developments: ARYx Therapeutics, Inc. (ARYX.O)
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Latest Key Developments
ARYx Therapeutics, Inc. Receives Guidance On Anticoagulant Agent Tecarfarin
ARYx Therapeutics, Inc. announced that it has received guidance in writing from the U.S. Food and Drug Administration (FDA) confirming that the existing development pathway remains acceptable to seek regulatory approval of ARYx's anticoagulant agent, tecarfarin (ATI-5923). This guidance results from a series of discussions between ARYx and the FDA following the recent completion of the Phase 2/3 EmbraceAC clinical trial in which tecarfarin essentially replicated the efficacy and safety demonstrated in two previous Phase 2 clinical trials testing the compound. ARYx sought guidance from the FDA on a number of key elements in the continued development of tecarfarin, including: whether the maintenance of a patients' therapeutic level of anticoagulation, as measured by the International Normalized Ratio (INR), could continue to serve as a surrogate measure of outcomes; whether one successful additional clinical trial, comparing the safety and efficacy of tecarfarin to warfarin, an anticoagulant therapy, in a real-world setting, could establish tecarfarin's superiority over warfarin and be sufficient for approval; and, preliminarily, the design elements of the real-world trial required for approval.
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.
ARYx Therapeutics, Inc. Announces Successful Outcome of Atrial Fibrillation Clinical Trial on ATI-2042
ARYx Therapeutics, Inc. announced successful top-line efficacy 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. By achieving statistical significance at the two highest doses of the three tested, the results essentially mirrored the findings of an earlier Phase 2 study also conducted in paroxysmal atrial fibrillation patients. Complete results from this study are expected in the first quarter of 2009.
ARYx Therapeutics, Inc. Presents Clinical Data For ATI-5923
ARYx Therapeutics, Inc. announced that clinical data for ATI-5923, a vitamin K epoxide reductase (VKOR) inhibitor in Phase 2/3 development for the treatment of patients at risk of forming dangerous blood clots, were presented at the American Heart Association (AHA) Scientific Sessions 2008 in New Orleans, LA. The data featured in these presentations indicate that ATI-5923 has potential advantages over the drug warfarin, including possible reduction of drug-drug interactions (DDIs), more predictable dosing and better anticoagulation control. These data are significant because, in the clinical setting, DDI-induced increase in warfarin exposure is associated with increased anticoagulant effect and risk of bleeding. ATI-5923 was designed to have an alternative metabolic pathway, so it should avoid metabolic DDIs with other drugs that inhibit or induce CYP450 enzymes. This could give ATI-5923 a distinct advantage over the current standard of care.
ARYx Therapeutics, Inc. Announces Private Placement
ARYx Therapeutics, Inc. announced that it has entered into a securities purchase agreement in connection with a private placement to a group of accredited investors led by new investor New Enterprise Associates (NEA) with participation from significant existing shareholders including MPM Capital and OrbiMed Advisors LLC. Pursuant to the terms of the securities purchase agreement, ARYx will receive approximately $21.6 million in gross proceeds from the sale of 9,649,545 shares of its common stock and the issuance of warrants for the purchase of 2,894,864 additional shares of ARYx's common stock with an exercise price of $2.64 per share and having a term of five (5) years from the closing date. The combined purchase price of a share of ARYx's common stock and a warrant to purchase 0.30 of a share of ARYx's common stock is $2.2375.
ARYx Therapeutics, Inc. Announces Successful Results of Chronic Constipation Clinical Trial on ATI-7505
ARYx Therapeutics, Inc. announced the results of a Phase 2b clinical trial testing the safety and efficacy of its prokinetic agent, ATI-7505, in patients with chronic idiopathic constipation. The clinical trial, conducted by Procter and Gamble Pharmaceuticals (P&G), was designed to enroll 400 patients evaluating four doses of the agent compared to placebo. In spite of the early termination of the study, ATI-7505 achieved statistical significance at the study's primary endpoint in the 80 mg twice daily dose. In addition, all doses tested demonstrated a clinically meaningful increase in spontaneous bowel movements over baseline compared to placebo after one week of treatment.
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