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news.Arete Therapeutics, a biotechnology company, has initiated a Phase IIa clinical trial for AR9281, an orally-administered soluble epoxide hydrolase inhibitor being developed for the treatment of type 2 diabetes.
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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-naive 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.
Soluble epoxide hydrolase (s-EH) is an enzyme involved in the metabolism of arachidonic acid, a key signaling molecule implicated in diabetes, hypertension and inflammatory disorders.
James Sabry, president and CEO of Arete, said: 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.