SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. today announced that data was presented on the Company's lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, demonstrating potent activity in mouse models of colitis. An oral presentation of the data was given at Digestive Disease Week (DDW) 2008 in San Diego, California.
The MEK1/2 pathway is important in cell cycle regulation in inflammatory bowel disease, including ulcerative colitis and Crohn's disease. RDEA119 was shown to reduce damage to colonic tissue in two different mouse models of colitis, murine trinitrobenzene sulfonic acid (TNBS) colitis model and murine dextran sulfate sodium (DSS) colitis model. The beneficial effect observed equaled or exceeded that of sulfasalazine (Azulfidine(R)), a therapy commonly used for acute and maintenance treatment of ulcerative colitis.
"Despite the existing treatments, there are still significant unmet medical needs for inflammatory bowel disease. Blocking the MEK1/2 pathway appears to be a promising strategy in the ongoing search for a new generation of therapies aimed to treat ulcerative colitis and Crohn's disease," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "These data further support the potential use of orally administered MEK inhibitors, such as RDEA119, for the treatment of inflammatory diseases."
To support the development of RDEA119 in inflammatory diseases, a Phase 1 study in normal healthy volunteers is ongoing in which the Company is evaluating the pharmacokinetics, safety and tolerability of RDEA119, as well as its ability to inhibit inflammatory cytokines. Preliminary Phase 1 data have demonstrated that RDEA119 has a long half-life and favorable pharmacokinetic properties, allowing for once daily oral dosing. In addition, RDEA119 is currently in a Phase 1 study in advanced cancer patients. The doses being evaluated in the Phase 1 study in advanced cancer patients have achieved systemic exposure consistent with active doses in animal models of human tumors, without drug-related toxicity.
The presentation is available on the Company website (http://www.ardeabio.com/) under the title "RDEA119, a Potent and Highly Selective MEK Inhibitor Ameliorates Murine Colitis."
Corporate Update at Annual Stockholder Meeting
Ardea will provide a corporate update at its Annual Stockholder Meeting. The presentation is scheduled for Thursday, May 22nd, at 9:30 a.m. Pacific Time. To participate by telephone, please dial 877-440-5804 from the U.S. and Canada or +1-719-325-4854 for international callers. In addition, the live conference call is being webcast and can be accessed on the "News & Events" page of the Company's website at http://www.ardeabio.com. A replay will also be available on Ardea's website for 14 days and by telephone through May 31, 2008. For the telephonic replay, please dial 888-203-1112 in the U.S. and Canada or +1-719-457-0820 for international callers, and enter passcode 9342491 when prompted.
About RDEA119
RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the treatment of inflammatory diseases and cancer, is the Company's lead compound from its MEK inhibitor research and development program. RDEA119 has shown potential as a potent inhibitor of MEK, which is believed to play an important role in inflammation, as well as 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. The Company is also investigating a second generation MEK inhibitor, RDEA436, for potential use in inflammatory diseases and cancer. Preclinical data suggest that RDEA436 is a potent in vitro and in vivo inhibitor of MEK and may have favorable properties, such as low CNS penetration. In addition, RDEA436 has demonstrated a long half-life in a human micro-dose pharmacokinetic study, with the potential for once daily dosing in humans.
About Ardea Biosciences
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, cancer and inflammatory diseases, including gout. We have four drug candidates in clinical trials and others in preclinical development and discovery. Our most advanced development candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of 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 as a development candidate. RDEA594, our lead development candidate for the treatment of gout, is in preclinical development 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, as well as in 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 as a development candidate.
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: sufficiency of cash resources and 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 internal development 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.
CONTACT: Edie DeVine of WeissComm Partners, +1-415-946-1081, for Ardea
Biosciences, Inc.
Web site: http://www.ardeabio.com/
