Ardea Biosciences Presents Preclinical Anti-Inflammatory Data on its Lead MEK Inhibitor, RDEA119, at the ACG 2008 Annual Meeting

SAN DIEGO, Oct. 7 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (NASDAQ:RDEA) announced today that a poster entitled "RDEA119, a Potent and Highly Selective MEK1/2 Inhibitor is Beneficial in Dextran Sulfate Sodium (DSS) -- induced Chronic Colitis in Mice," was presented at the American College of Gastroenterology (ACG) 2008 Annual Meeting in Orlando, Florida. The poster, which provided data from a preclinical study of RDEA119, the Company's lead mitogen-activated ERK kinase (MEK) inhibitor, showed the product candidate to be a promising investigational therapy for inflammatory diseases.
 

Oral administration of RDEA119 was shown to significantly reduce damage to colonic tissue and disease activity in dextran sulfate sodium (DSS) -- induced chronic colitic mice. The beneficial effect of RDEA119 exceeded that of Remicade(R) (infliximab), the current standard-of-care for the treatment of ulcerative colitis.
 

"Blocking the MEK1/2 pathway appears to be a promising strategy for treating inflammatory disease, for which a significant unmet medical need still exists," commented Dr. Barry Quart, PharmD, president and chief executive officer. "We are making excellent progress with our programs addressing inflammatory disease and the data presented today demonstrate the potential of our MEK inhibitors, RDEA119 and our second generation MEK inhibitor, RDEA436, as treatments for these diseases, and support our continued efforts in this area."
 

Earlier this year, the Company successfully completed a Phase 1 study of RDEA119 in healthy volunteers in which the product candidate demonstrated a long half-life and a favorable pharmacokinetic profile. The Company plans to initiate a Phase 1b clinical trial of RDEA119 in gouty arthritis later this year. In addition, RDEA119 is being evaluated in a Phase 1 trial in patients with advanced cancer, and will be also be evaluated in a Phase 1/2 clinical trial in the fourth quarter of 2008 in combination with Nexavar(R) (sorafenib) in advanced cancer patients. The Company also plans to initiate a Phase 1 trial of RDEA436, its second-generation MEK inhibitor, in healthy volunteers, in the fourth quarter of this year.
 

About RDEA119 and RDEA436
 

RDEA119 and RDEA436, non-ATP competitive, highly-selective MEK inhibitors for the treatment of cancer and inflammatory diseases, are two of the compounds from Ardea's MEK inhibitor research and development program. RDEA119 has shown potential as a potent and selective inhibitor of MEK, which is believed to play an important role in cancer cell proliferation, apoptosis and metastasis. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects. Preclinical data show that RDEA436 is a potent in-vitro and in-vivo inhibitor of MEK, has favorable pharmacokinetic properties with low CNS penetration and a long half-life in a human micro-dose study indicating the potential for once daily dosing in humans.
 

About Ardea Biosciences, Inc.
 

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.
 

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with our drug discovery and development programs and business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
 

Source: Ardea Biosciences, Inc.

CONTACT: John Beck of Ardea Biosciences, Inc., +1-858-652-6523,
jbeck@ardeabio.com
 

Posted: October 2008

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