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Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent


11/1/2007 7:22:35 AM

HAYWARD, Calif., Nov. 1 /PRNewswire/ -- Arete Therapeutics Inc. today announced the initiation of a phase 1 clinical trial for its lead compound, AR9281, for the treatment of hypertension. AR9281 is a "first-in-class," orally-active inhibitor of soluble epoxide hydrolase (s-EH), a novel target for the treatment of hypertension. The trial will enroll up to 32 healthy adult volunteers and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics for single ascending doses of AR9281.

"AR9281 inhibits s-EH, an enzyme that plays a key role in the cytochrome P450 pathway of arachidonic acid metabolism, and offers a unique mechanism of action as an antihypertensive agent," said Dinesh V. Patel, Ph.D., president and chief executive officer of Arete Therapeutics Inc. "We believe this first-in-class compound has great potential to be a unique 'antihypertensive-plus' drug that not only lowers blood pressure but also offers end organ protection of the heart and kidney, and protection against vascular inflammation."

"The preclinical safety and efficacy profile of AR9281 is very encouraging and provided a solid basis for the initiation of the clinical development phase of this new compound class," commented Randall Whitcomb, M.D., chief medical officer of Arete Therapeutics Inc. "We look forward to reporting results from the initial phase 1 clinical trial in 2008."

Arete Therapeutics' phase 1 single ascending dose, placebo-controlled clinical trial in healthy volunteers will obtain initial safety and tolerance information as well as detailed blood pressure measurements. Levels of s-EH specific biomarkers will be analyzed together with typical inflammatory markers as part of the pharmacodynamic assessment. Following successful completion of the single dose study, Arete plans to initiate a multiple dose phase 1 study, a food effect study, and studies in special populations.

About AR9281

AR9281 is a novel small molecule inhibitor of soluble epoxide hydrolase (s-EH), an enzyme which plays a key role in arachidonic acid metabolism, and has the potential to be a first-in-class antihypertensive agent with end organ protection and anti-inflammatory properties. AR9281 has shown activity in multiple animal models of hypertension and vascular inflammation. In addition, Arete has evaluated AR9281 in numerous in vitro and in vivo assays for potency, selectivity, efficacy, ADME, toxicity and safety with very favorable results.

Over the past decade, various academic institutions have proven the therapeutic utility of s-EH inhibitors in multiple models of hypertension, demonstrating that they lower elevated blood pressure, provide a protective effect on the kidney, heart and brain, and possess anti-inflammatory properties. Based on positive preclinical data, Arete is pursuing additional studies to explore the impact of s-EH inhibition on inflammation and the metabolic syndrome.

About Hypertension

Hypertension impacts more than 50 million people in the US and over 1 billion people worldwide. The risk of hypertension increases with age and is likely to represent one of the single most common chronic diseases in an aging population. The relationship between high blood pressure and the risk of cardiovascular disease is continuous, consistent, and independent of all other risk factors. The aggressive management of elevated blood pressure has consistently been shown to reduce the rates of stroke, heart attack, and heart failure. Current therapies are often changed or discontinued within the first 6 months in most medical practices, likely reflecting a combination of adverse drug effects, poor efficacy, and a lack of understanding of target organ damage.

About Arete Therapeutics Inc.

Arete Therapeutics Inc. is a privately held pharmaceutical Company discovering and developing first-in-class small molecule drugs directed at soluble epoxide hydrolase (s-EH), a novel target for cardiovascular, metabolic and inflammatory diseases. By targeting s-EH which plays a key role in the arachidonic acid pathway, the Company is addressing the very large market need for a unique anti-hypertensive drug with renal sparing, cardio-protective and anti-inflammatory properties. Arete has discovered and developed a series of proprietary and chemically diverse molecules with preclinical efficacy in various animal models of hypertension, metabolic syndrome, and inflammation, and is conducting a phase 1 clinical trial with its first-in-class antihypertensive drug AR9281. The Company has raised a total of $51 million in Series A financing led by Frazier Healthcare Ventures (http://www.frazierhealthcare.com), Alta Partners (http://www.altapartners.com), Three Arch Partners (http://www.threearchpartners.com), Burrill & Company (http://www.burrillandco.com) and Altitude Life Science Ventures (http://www.altitudefunds.com). For more information on Arête Therapeutics, please visit http://www.aretetherapeutics.com.

CONTACT: Angela Bitting, +1-925-202-6211, a.bitting@comcast.net, for Arete
Therapeutics

Web site: http://www.aretetherapeutics.com/



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