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In the first cohort of this small placebo- and active-controlled study of 21 gout patients with hyperuricemia, 11 patients were randomized to blinded RDEA594 200mg once-daily (qd) for one week followed by RDEA594 400mg qd for one week, five patients were randomized to blinded placebo for two weeks and five patients were randomized to open-label allopurinol 300mg qd for two weeks.
All patients receiving RDEA594 experienced a dose-related reduction in uric acid levels in their blood. Patients who excrete less than normal amounts of uric acid make up approximately 90% of the gout patient population and are the primary target for treatment with RDEA594.
In this study, the response rate to RDEA594 in these patients was 60% after two weeks of treatment. A majority of patients randomized to RDEA594 also had mild to moderate renal impairment at baseline and 86% of those patients responded to RDEA594 at two weeks.
RDEA594 increased urinary excretion of uric acid in the under-excretor patients in this study to pre-treatment levels seen in normal healthy volunteers in prior studies. Avoiding excessive clearance of uric acid should reduce the risk of renal toxicity. 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.
In the ongoing second cohort of this trial, six gout patients with hyperuricemia will receive allopurinol 300mg qd for one week followed by the addition of RDEA594 or placebo for two more weeks.
Preclinical models did not show any drug-drug interactions between RDEA594 and either allopurinol or febuxostat. Ongoing studies in humans will provide additional evidence to support the potential use of these combinations. An update on animal safety studies was also presented with recent results from a three-month and six-month assessment of chronic toxicity in rats and monkeys, respectively, showing no organ toxicity with RDEA594. In particular, no renal toxicity was noted in clinical chemistry, gross pathology or histopathology at doses up to 300mg/kg/day, said Ardea.
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