Nov. 6, 2009 (PR Newswire) -- SAN DIEGO, Nov. 6 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the third quarter and nine months ended September 30, 2009.
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"Since our last quarterly update, we have confirmed the activity of RDEA594 in gout patients, and we have initiated the four planned studies in our broad-based Phase 2 development program," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "The Phase 2a results demonstrate the ability of RDEA594 to normalize renal excretion of uric acid in patients that have gout due to their inability to excrete sufficient amounts of uric acid. These under-excretors of uric acid make up approximately 90% of the patients with hyperuricemia and gout, and are the primary target population for RDEA594," added Dr. Quart.
Recent Accomplishments
-- On October 19, 2009, we presented at the 2009 American College of
Rheumatology (ACR) / Association of Rheumatology Health Professionals
(ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania,
additional data from the first cohort of an ongoing Phase 2a
proof-of-concept study of RDEA594, our lead product candidate in
development for the treatment of hyperuricemia and gout. Important
highlights from this study were:
-- All patients receiving RDEA594 experienced a dose-related reduction
in serum uric acid levels and a majority achieved a reduction in
serum urate to levels less than 6 mg/dL.
-- 60% (6/10) of patients in this group who excrete less than normal
amounts of uric acid in their urine responded to therapy by
achieving a reduction in serum urate to levels less than 6 mg/dL
after two weeks of treatment.
-- RDEA594 also produced significant reductions in serum urate in
patients with mild to moderate renal impairment, with 83% (5/6) of
these patients responding after two weeks of treatment. Gout
patients with mild to moderate renal impairment represent a
substantial portion of the gout patient population and are often not
effectively treated with allopurinol.
-- RDEA594 was also well tolerated in this study, with no serious
adverse events and no premature discontinuations due to adverse
events in patients receiving RDEA594.
-- Ardea also presented at the ACR/ARHP meeting data from preclinical
drug-drug interaction studies demonstrating RDEA594's potential to be
used in combination with allopurinol and febuxostat (Uloric®, Takeda
Pharmaceutical Company Limited; Adenuric®, Ipsen) and an update from a
3- and 6-month assessment of chronic toxicity in rats and monkeys,
respectively, showing no organ toxicity at doses up to 300 mg/kg/day.
Clinical Development Efforts and Important Upcoming Clinical Development Milestones
-- All studies in our RDEA594 Phase 2 clinical development program have
been initiated. These studies include a Phase 2b single-agent
dose-response study evaluating the safety and urate-lowering effects of
200, 400 and 600 mg of RDEA594 in 140 gout patients (RDEA594-202), a
Phase 2b combination study evaluating RDEA594 as an add-on to
allopurinol in approximately 100 patients who do not respond adequately
to allopurinol alone (RDEA594-203), a drug-drug interaction study with
febuxostat in healthy volunteers (RDEA594-105), and a study in gout
patients with renal impairment (RDEA594-204).
-- We expect to provide results from the second cohort of our ongoing Phase
2a proof-of-concept study evaluating RDEA594 in combination with
allopurinol and Study RDEA594-105, along with an update on progress in
RDEA594-204, in December 2009. We expect RDEA594-202 to complete
enrollment in 2009, with results anticipated in the first quarter of
2010.
