Ardea Biosciences Provides Additional Results From A Phase 2b Study Of Lesinurad In Combination With Allopurinol At The Annual European Congress Of Rheumatology
LONDON, May 25, 2011 /PRNewswire/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that additional positive clinical and preclinical results from its development program of lesinurad, the Company's lead product candidate for the treatment of hyperuricemia and gout, were presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in London, UK.
Results from Primary Dosing Period and Ongoing Extension of Phase 2b Combination Study with Allopurinol
Results presented from the ongoing blinded extension portion of Ardea's Phase 2b study (study 203) of lesinurad in patients who did not achieve target on allopurinol therapy alone demonstrated that for those patients who have reached week 28 of the extension period, 91 percent of those patients receiving lesinurad in combination with allopurinol achieved serum urate (sUA) levels below the clinically important target of 6 mg/dL. Importantly, continued reductions in sUA were observed beyond the initial 28 days of dosing with a majority of the responding patients remaining on a 200 mg dose of lesinurad thus far in the extension period. These preliminary results are from the extension portion of a 28-day, randomized, double-blind, placebo-controlled Phase 2b study evaluating lesinurad in combination with allopurinol in 208 gout patients with elevated sUA greater than or equal to 6 mg/dL who were not adequately responding despite being on a stable dose of allopurinol. Following the 28-day primary dosing period and at least a two-week washout, 126 patients entered the optional extension period and restarted dosing with 200 mg of lesinurad or placebo. Non-responding patients can be escalated up to 400 mg or 600 mg of lesinurad, at the investigators' discretion. Currently, 30 patients have been dosed for at least 6 months.
Final results were also presented from the completed 28-day main portion of study 203. At the highest lesinurad dose tested in this study, patients achieved a 30 percent mean reduction in sUA levels after 4 weeks, compared to a 3 percent mean increase on allopurinol plus placebo (p< 0.0001). This resulted in a response rate of 79 percent for the 600 mg dose (p< 0.0001) using the more rigorous "intent-to-treat" (ITT) analysis and 87 percent using a "last observation carried forward" (LOCF) analysis. As a result, the number of patients taking the combination who achieved the medically recommended target of below 6 mg/dL was more than three times the number of patients who achieved the target on allopurinol alone.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV