Recently, Ardea Biosciences, Inc. (RDEA) announced positive results from the first dosing group of a one-week randomized, placebo-controlled drug-combination study in normal healthy volunteers of its candidate for gout treatment, RDEA594 and Uloric (febuxostat) of Takeda. The treatment from the combination gave 20% better results in hyperuricemia (elevated uric acid levels) and gout patients, opposed to single agent therapy.
The study (baseline serum urate levels of greater than 5 mg/dL) is designed to evaluate the potential for pharmacokinetic drug interactions, coupled with the serum urate-lowering effect, safety and tolerability of escalating doses of RDEA594 once-daily combined with 40 mg febuxostat.
After seven days of dosing as monotherapy, both RDEA594 and febuxostat caused a 40% mean reduction in serum urate from the baseline. However, when they were administered in combination for a week, the two candidates produced a 60% mean reduction in serum urate from baseline.
The positive results from this study have encouraged Ardea to initiate a second dosing group to evaluate 400 mg of RDEA594 once daily in combination with 40 mg of febuxostat once daily. Furthermore, RDEA594 is being evaluated in other studies. They include a mid-stage single-agent dose-response study to evaluate the safety and urate-lowering effects of 200, 400, and 600 mg of the candidate, another mid-stage study which is evaluating RDEA594 as an add-on to allopurinol in patients failing to respond adequately to allopurinol alone, and a study in gout patients suffering from renal impairment.
Gout, a painful and debilitating disease caused by abnormally high uric acid levels in the blood, affects approximately 3-5 million people in the United States, and an estimated 5 million people in the European Union. The incidence and severity of gout is on the rise in the United States. There was a 288% increase in gout-related hospitalizations from 1988-2005. Only one drug, febuxostat, has been approved for hyperuricemia in the U.S. in the last four decades. We believe RDEA 594, which has been well-tolerated in clinical development so far, can serve the market which has a huge unmet medical need, effectively on approval.
Currently, we are Neutral on Ardea Biosciences.
Read the full analyst report on “RDEA”
Zacks Investment Research
