Ardea reports positive interim results from Phase IIa gout trial

Look up the PowerRating of RDEA and see how it has performed over the past week as well as the current proprietary PowerRating.

Jun 12, 2009 (Datamonitor via COMTEX) -- RDEA | Quote | Chart | News | PowerRating -- Ardea Biosciences, a biotechnology company, has reported positive interim results from an ongoing Phase IIa, 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 I studies of RDEA594 in normal, healthy volunteers.

In late April 2009, the company initiated a placebo- and active-controlled, proof-of-concept study of RDEA594 in gout patients with hyperuricemia. This study is now fully enrolled and the majority of the 20 patients have completed the first week of dosing. Patients received RDEA594 200mg once daily (QD) for the first week, followed by 400mg QD for the second week. An immediate release (IR) capsule formulation, administered under fed conditions, was used in this study.

Of the first seven patients randomized to RDEA594 to reach eight days of dosing (first day after dose increased to 400mg QD), six, or 86%, were responders, as defined by the achievement of target uric acid concentrations of less than 6mg/dl. This compares to zero out of four patients randomized to placebo and two out of three patients randomized to a standard dose of allopurinol (300mg QD) to reach eight days of dosing, the company said.

On average, RDEA594-treated patients achieved a 40% reduction in serum urate levels by this early time point. Dosing in this Phase IIa study is expected to be completed in late June 2009, with full results to be presented shortly. RDEA594 has been well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events.

Results from two completed, randomized, double-blind, placebo-controlled, Phase I studies included data from 98 adult male subjects, of which 76 received RDEA594 at doses from 5mg to 600mg for one to 10 days. Statistically significant, dose-dependent reductions in serum urate of up to 45% were demonstrated in the multiple-ascending-dose study, which evaluated QD doses of RDEA594 100mg oral solution and 200 and 400mg IR capsules given fasted or placebo over a 10-day dosing period.

Administration of the IR capsule with a standard breakfast, as done in the Phase IIa study, improved the pharmacokinetic profile of the drug and increased the reduction in uric acid compared to fasted conditions. RDEA594 was well tolerated at all dose levels tested, including single doses of an oral solution up to 600mg, multiple doses of the IR capsules up to 400mg QD, and multiple doses of an experimental extended-release tablet up to 600mg QD, Ardea said.

Barry Quart, president and CEO of Ardea, said: "These very encouraging interim data from our Phase IIa study have confirmed the activity and safety of RDEA594 in gout patients and our formulation and dose selections for the upcoming Phase IIb program. With the RDEA594 proof-of-concept data now in hand and our recent experience rapidly enrolling gout patients, we look forward to successfully completing major components of our Phase IIb evaluation of RDEA594 as planned in the fourth quarter of 2009."

http://www.datamonitor.com

Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall 
not be liable for errors or delays in the content, or for any actions 
taken in reliance thereon

More News:   Market Updates | Stock Alerts | All Trading News | Stock Index