(RTTNews) - Tuesday, Ardea Biosciences, Inc. (RDEA: News ) said results from the first dosing group of a one-week drug-combination study of its lead product candidate RDEA594 and febuxostat indicate that the combination therapy produced 20% better results in hyperuricemia and gout patients, compared to single agent therapy. The company said these results show that this combination may be able to reduce tophaceous gout similar to intravenous therapy.

After one week of dosing as monotherapy, both RDEA594 and febuxostat produced a mean reduction in serum urate of 40% from baseline. When administered in combination for seven days, the two agents produced a mean reduction in serum urate of 60% from baseline, Ardea said in a statement.

Gout is a painful form of arthritis that is caused by abnormally elevated levels of uric acid in the blood stream due to under-excretion of uric acid. RDEA594 is a selective inhibitor of URAT1, which is a transporter in the kidney that regulates uric acid excretion from the body. Febuxostat is indicated for the treatment of hyperuricemia and gout, and is marketed under the brand name Uloric by Takeda Pharmaceutical Company (TKPHF.PK) and Adenuric by Ipsen SA.

John Sundy MD, PhD, associate professor of medicine at Duke University Medical Center and a member of Ardea's scientific advisory board, said, "The substantial reduction in serum uric acid observed when RDEA594 and febuxostat are co-administered indicate that these two oral agents with complementary mechanisms may be able to accelerate improvement in tophaceous gout compared to single agent therapy. I look forward to studying this combination in patients with advanced disease."
Barry Quart, chief executive officer of Ardea, said, "Similar reductions in serum urate produced when RDEA594 and febuxostat were administered alone, and the substantial reduction produced when these agents were administered in combination supports our strategy to develop RDEA594 as both monotherapy and in combination with xanthine oxidase inhibitors, such as febuxostat or allopurinol. With the dramatic reduction in serum uric acid observed when RDEA594 and febuxostat are administered in combination, together these agents may be able to produce reductions in tophaceous gout previously achieved only with intravenous therapy."

The randomized, placebo-controlled study was conducted in normal healthy volunteers with baseline serum urate levels of greater than 5 mg/dL. The study was designed to evaluate the potential for pharmacokinetic drug interactions, as well as the serum urate-lowering effect, safety and tolerability of escalating doses of RDEA594, administered once-daily in combination with 40 mg febuxostat.

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