SAN DIEGO, Jan. 6, 2011 /PRNewswire/ -- Ardea Biosciences,
Inc. (Nasdaq: RDEA) today announced positive, preliminary, top-line
results from its Phase 2b study of RDEA594 in combination with the
current standard of care for the treatment of gout, allopurinol.
Allopurinol currently accounts for greater than 90% of the
unit sales of chronic gout prescription medications; however, in
controlled trials, only 30-40% of gout patients respond adequately
to allopurinol as defined by the achievement of a serum uric acid
(sUA) level of less than 6 mg/dL, the medically recommended target.
In this Phase 2b study, the primary and key secondary
endpoints were achieved, with highly statistically significant
reductions in sUA and up to 89% of patients taking a combination of
RDEA594 600 mg and allopurinol reaching target sUA. RDEA594,
Ardea's lead product candidate for the chronic treatment of gout,
is an orally administered compound that inhibits the URAT1
transporter, a biological mechanism that is complementary to the
mechanism of allopurinol and that of the most recently approved
oral drug for gout, febuxostat (Uloric ®).
This was a 28-day, randomized, double-blind, placebo-controlled,
study conducted in 208 gout patients with elevated uric acid levels
(sUA greater than or equal to 6 mg/dL) despite being on a stable
dose of allopurinol. In the study, patients remained on a
stable dose of allopurinol and also received once daily doses of
200 mg RDEA594, 400 mg RDEA594, 600 mg RDEA594 or placebo.
For patients randomized to receive 400 mg RDEA594 and 600 mg
RDEA594, the RDEA594 daily dose was escalated weekly in increments
of 200 mg/day. The primary endpoint of the study was the
percent reduction in sUA after 4 weeks of treatment with the
combination compared to allopurinol alone. A key secondary
efficacy endpoint was the proportion of patients who achieved a
response, defined as a reduction of sUA below the clinically
relevant target of < 6 mg/dL, after 4 weeks of combined RDEA594
and allopurinol treatment, compared to allopurinol and placebo.
Reductions in sUA and response rates increased in a dose-related
manner when RDEA594 was combined with allopurinol and were highly
clinically and statistically significant at all dose levels when
compared to allopurinol alone. At the highest dose tested of
600 mg, there was a 30% mean reduction in sUA levels after 4 weeks,
compared to a 3% mean increase on placebo (p