Arete Therapeutics Initiates Phase IIa Clinical Trial for AR9281, a Novel s-EH Inhibitor to Treat Type ...( HAYWARD Calif. Feb. 10 /- Arete T...),Health

HAYWARD, Calif., Feb. 10 /PRNewswire/ -- Arete Therapeutics Inc. today announced the initiation of a Phase IIa clinical trial for AR9281, an orally- administered soluble epoxide hydrolase (s-EH) inhibitor being developed for the treatment of type 2 diabetes. S-EH is an enzyme involved in the metabolism of arachidonic acid, a key signaling molecule implicated in diabetes, hypertension and inflammatory disorders.

"Our AR9281 Phase II clinical trial program breaks new ground in two key areas. This is the first clinical study of a s-EH inhibitor in patients, and the first study designed to establish proof of concept that s-EH inhibition modulates glucose metabolism or blood pressure in patients with impaired glucose tolerance and hypertension," said James Sabry, M.D., Ph.D., President and Chief Executive Officer of Arete Therapeutics. "AR9281 has demonstrated an excellent safety profile and activity in multiple animal models of type 2 diabetes, and has the advantage of inhibiting a novel drug target that differentiates it from currently marketed diabetes medications. With this promising drug profile, AR9281 has the potential to provide safe and effective therapy for patients with type 2 diabetes either as monotherapy or in combination with existing treatment regimens."

The Phase IIa multicenter, double-blind, placebo-controlled study will enroll 150 pre-diabetic patients with impaired glucose tolerance, mild obesity and mild to moderate hypertension. All patients enrolled in the study will be treatment-naïve for type 2 diabetes medications. The trial will evaluate two schedules of AR9281 and placebo using a parallel design to determine the feasibility of twice-a-day dosing. Each patient will receive 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.'/>"/>