Key Developments For Ardea Biosciences, Inc.
Ardea Biosciences, Inc. (RDEA.O) (Consolidated Issue listed on NASDAQ Global Market)
Ardea Biosciences, Inc. Reports Positive Results From Combination Of RDEA594 And Febuxostat
Ardea Biosciences, Inc. announced positive results from the first dosing group of an ongoing drug-drug interaction and pharmacodynamic study of RDEA594, its product candidate for the treatment of hyperuricemia and gout, and febuxostat (Uloric, Takeda Pharmaceutical Company Limited; Adenuric, Ipsen). This randomized, placebo-controlled study in normal healthy volunteers with baseline serum urate levels of greater than 5 mg/dL is 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 (QD) in combination with 40 mg febuxostat. In the first two periods of the initial dosing group, 18 subjects received either 200 mg of RDEA594 QD or matching placebo for seven days or 40 mg of febuxostat QD for seven days, and then the combination of the two regimens for seven days. The combination of RDEA594 and febuxostat in this first dosing group was well tolerated and no pharmacokinetic drug interactions were observed. After one week of dosing as monotherapy, both RDEA594 and febuxostat produced a mean reduction in serum urate of approximately 40% from baseline. When administered in combination for seven days, the two agents produced a mean reduction in serum urate of approximately 60% from baseline, with intraday reductions of almost 75%. No clinically relevant adverse effects or laboratory abnormalities were observed during administration of RDEA594.
Ardea Biosciences, Inc. Announces Additional Positive Results From Phase 2a Study of RDEA594
Ardea Biosciences, Inc. announced positive results from the completed cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. These results, as well as data from a preclinical drug-drug interaction study demonstrating RDEA594's potential to be used in combination with allopurinol and febuxostat (Uloric, Takeda Pharmaceutical Company Limited; Adenuric, Ipsen). In the first cohort of small placebo- and active-controlled study of 21 gout patients with hyperuricemia (serum urate ≥ 8 mg/dL), 11 patients were randomized to blinded RDEA594 200 mg once-daily (qd) for one week followed by RDEA594 400 mg qd for one week, 5 patients were randomized to blinded placebo for two weeks and 5 patients were randomized to open-label allopurinol 300 mg 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 (response defined as serum urate to < 6 mg/dL) to RDEA594 in these patients was 60% (6/10) after two weeks of treatment. A majority of patients randomized to RDEA594 also had mild to moderate renal impairment (Creatinine Clearance by Cockcroft-Gault method = 50-89 ml/min) at baseline and 86% of those patients responded to RDEA594 at two weeks.
Ardea Biosciences, Inc. To Present Results From Phase 2a Study Of RDEA594
Ardea Biosciences, Inc. announced that it will present results from a Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, at the 2009 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania. Previously disclosed interim results will be updated to include final single-agent cohort data, as well as data demonstrating RDEA594`s ability to lower serum urate to less than 6.0 mg/dL in patients with mild to moderate renal insufficiency, which was the majority of patients randomized to RDEA594. In addition, the Company will provide an update on improved drug formulations and will present data from a preclinical drug-drug interaction study demonstrating RDEA594`s potential to be used in combination with allopurinol and febuxostat (Uloric, Takeda Pharmaceutical Company Limited; Adenuric, Ipsen), both of which lower serum urate via a different mechanism of action than RDEA594. About RDEA594 and RDEA684 RDEA594 is a selective URAT1 transporter inhibitor that is in Phase 2 development as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat (Uloric, Takeda Pharmaceutical Company Limited; Adenuric, Ipsen). Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug.
Ardea Biosciences, Inc.'s RDEA684 Selected As Development Candidate For Treatment Of Gout
Ardea Biosciences, Inc. announced that it has initiated a Phase 2b clinical trial of RDEA594, its product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a URAT1 inhibitor, as a development candidate for the same indication. The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more). The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (Uloric, Takeda Pharmaceutical Company Limited; Adenuric, Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
Ardea Biosciences, Inc. Announces Positive Interim Phase 2a Results for Lead Gout Drug, RDEA594
Ardea Biosciences, Inc. announced positive interim results from an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, as well as additional positive results from completed Phase 1 studies of RDEA594 in normal, healthy volunteers. The Phase 1 results, along with additional preclinical data, were presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Copenhagen, Denmark. This study is now fully enrolled and the majority of the 20 patients have completed the first week of dosing. Patients received RDEA594 200 mg once daily (QD) for the first week, followed by 400 mg QD for the second week. An immediate release (IR) capsule formulation, administered under fed conditions, was used in this study. Of the first 7 patients randomized to RDEA594 to reach 8 days of dosing, 6, or 86%, were responders, as defined by the achievement of target uric acid concentrations of less than 6 mg/dL. This compares to zero out of 4 patients randomized to placebo and 2 out of 3 patients randomized to a standard dose of allopurinol (300 mg QD) to reach 8 days of dosing. On average, RDEA594-treated patients achieved a 40% reduction in serum urate levels by this early time point. Dosing in this Phase 2a study is expected to be completed in late June 2009, RDEA594 has been well tolerated in this study, with no serious adverse events.
