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DewDiligence

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Re: genisi post# 60290

Thursday, 03/13/2008 5:40:27 AM

Thursday, March 13, 2008 5:40:27 AM

Post# of 252897
ATI-5923 info from ARYX website:

http://www.aryx.com/wt/page/ati5923

ATI-5923 is an oral anticoagulant in Phase 2 clinical trials for the treatment of patients who are at risk for the formation of dangerous blood clots, such as those with atrial fibrillation or those at risk of venous thromboembolism. ATI-5923 is designed to have the same therapeutic benefits as the warfarin, which for over 50 years has been the treatment of choice as an oral anticoagulant. [I would say that warfarin has been the treatment of necessity, rather than the treatment of choice.]

Despite its widespread use, warfarin has several significant limitations. It is metabolized by CYP450 and has many drug-drug interactions that often lead to serious side effects. ATI-5923 is designed to be metabolized through the esterase pathway, eliminating metabolism through CYP450 and avoiding drug-drug interactions. Warfarin also has a very steep dose response curve which means that a small change in dose may lead to a substantial change in the anticoagulation status of the patient. This can put patients at risk for either life-threatening clotting or bleeding. In preclinical testing, it appears that ATI-5923 may have a flatter dose response curve than warfarin.

Atrial fibrillation is the most common form of cardiac arrhythmia, or abnormal heart rhythm, with approximately 2.4 million people in the United States currently diagnosed with this condition. There were approximately 510,000 patients being treated for venous thromboembolism in the U.S in 2005.

ATI-5923 is a selective inhibitor of the vitamin K epoxide reductase enzyme, or a VKOR inhibitor. The blood clotting process in the body is a complex and well-controlled cascade of events that involves multiple clotting factors. Four of these factors are known to be controlled by the VKOR enzyme. ATI-5923, like warfarin, is a VKOR inhibitor and by inhibiting this enzyme acts as an anticoagulant.

Atrial Fibrillation, Valvular Heart Disease, and Deep Vein Thrombosis

There are three major indications where ATI-5923 has the potential for use:

• Atrial Fibrillation is the most common form of cardiac arrhythmia, with approximately 2.4 million people in the United States diagnosed with this condition in 2006. Approximately 1.5 million of these patients are chronic users of oral anticoagulants. Atrial fibrilation is caused when the atria quiver instead of beat, causing the heart to beat erratically. Because the pumping function of the upper chambers of the heart are not working properly in atrial fibrillation patients, blood is not completely emptied from the heart's chambers, causing it to pool and sometimes clot. In patients with atrial fibrillation, clotted blood can dislodge from the atria and flow to the brain, causing a stroke. It is estimated that atrial fibrillation is responsible for more than 75,000 strokes per year in the United States alone.

• Valvular Heart Disease is any disease that involves one or more of the heart's four valves. For more advanced disease, the diseased valves may be replaced with either tissue or mechanical valves. It is estimated that 72,000 patients in the United States had either a tissue or mechanical valve replacement in 2005. Patients with mechanical heart valves are at great risk of clotting and must have their level of anticoagulation managed with particular diligence for the remainder of their lives. There are an estimated 340,000 patients with mechanical heart valves in the United States and an estimated 34,000 mechanical valve replacements in 2005. Chronic oral anticoagulant therapy is almost always prescribed for patients with mechanical valves and is frequently prescribed for patients after tissue valve replacement surgery to reduce the risk of thromboembolic complications caused by the presence of the valve.

• Venous Thromboembolism is the formation of a blood clot, or thrombus, in the veins, that may travel to other parts of the body and block blood flow. This condition includes both deep vein thrombosis and pulmonary embolism. There were approximately 510,000 patients being treated for venous thromboembolism in the United States in 2005, with approximately 130,000 estimated to be receiving chronic treatment. Chronic oral anticoagulant therapy, frequently with warfarin, is prescribed to both prevent and treat the formation of blood clots that cause venous thromboembolism.

ATI-5923 Development Status

We are currently conducting a Phase 2 clinical trial assessing ATI-5923's safety and efficacy. This is the first Phase 2 trial in a development strategy intended to not only evaluate safety and efficacy but also to assess the potential for therapeutic superiority of ATI-5923 over warfarin. If successful, we believe the clinical development of ATI-5923 will establish its safety, ease of use and superior efficacy, making it preferable to warfarin as an anticoagulant. We intend to use this proof-of-concept trial and other Phase 2 trials to enable a collaboration with a pharmaceutical partner for the further development and commercialization of ATI-5923.
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