Arete Therapeutics Initiates Phase IIa Clinical Trial for AR9281, a Novel s-EH Inhibitor to Treat Type 2 Diabetes
Posted on: Tuesday, 10 February 2009, 07:00 CST
"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
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.
"AR9281 operates within the third branch of the arachidonic acid pathway
and represents a potentially more specific and selective approach to intervene
in metabolic and inflammatory diseases. 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). We designed our Phase IIa trial to further validate
the role of s-EH in the pathophysiology of disease and to lay the groundwork
for further exploration of s-EH inhibition in treating a broad range of
serious diseases including type 2 diabetes, hypertension and inflammatory
disorders," commented
The results of a Phase I clinical program 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 Arete Therapeutics Inc.
Arete Therapeutics is a privately-held biotechnology company dedicated to
the discovery and development of novel drugs to treat type 2 diabetes,
hypertension and inflammatory disorders. It is the world's leading company
focused on s-EH, an important enzyme for the metabolism of arachidonic acid
that plays an essential role in metabolic, inflammatory and cardiovascular
physiology. The Company was founded by Dr.
SOURCE Arete Therapeutics Inc.
Source: PR Newswire
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