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AR9281 Phase II Program Underway

Arete is conducting a Phase IIa multicenter, double-blind, placebo-controlled study of AR9281 in pre-diabetic patients with impaired glucose tolerance, mild obesity and mild to moderate hypertension. All 150 enrolled patients will be treatment-naive for type 2 diabetes medications. The trial is evaluating two schedules of AR9281 and placebo using a parallel design to determine the feasibility of twice-a-day dosing. Each patient receives 28 days of treatment. Endpoints for the trial include safety, tolerability, reduction of blood pressure and various measures of glucose and lipid metabolism, with results expected in the first quarter of 2010.

The Phase I clinical program for AR9281, consisting of two double-blind, placebo-controlled studies, demonstrated that AR9281 was safe and well tolerated in healthy volunteers. The studies met all safety, tolerability, pharmacokinetic and pharmacodynamic endpoints. In addition, AR9281 has shown favorable results in various published and proprietary in vitro and in vivo assays for potency, selectivity, efficacy, ADME, toxicity and safety.

About AR9281

AR9281, an orally-administered soluble epoxide hydrolase (sEH) inhibitor, operates within the third branch of the arachidonic acid pathway and represents a novel and potentially more effective approach to treating type 2 diabetes, hypertension and inflammatory disease. The first two branches of this critical regulatory pathway have been targeted by several commercially successful marketed anti-inflammatory drugs including Aspirin(R) (acetylsalicylic acid), Motrin(R) (ibuprofen), Singulair(R) (montelukast) and Celebrex(R) (celecoxib). AR9281 has demonstrated an excellent safety profile and activity in multiple animal models
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