Shares of Ardea Biosciences (RDEA) surged 23 percent in after-market trading yesterday evening after the developer posted positive data for its dose-ranging, mid-stage trial of its experimental gout therapy. And the San Diego-based developer says it's ready to sit down with regulators later this year and start planning the late-stage trial.
Investigators enrolled 123 gout patients with hyperuricemia in the Phase IIb trial of RDEA594--its lead drug--and dosed them with 200, 400 and 600 mg of the drug or a placebo. The top two doses both hit the primary endpoint: showing a significant increase in the proportion of patients with reduced serum urate levels after four weeks of treatment. Researchers also reported that the drug was well tolerated with no serious adverse events to report.
At the highest dose, there was a 38 percent median reduction in serum urate levels after four weeks compared to a 1 percent increase on placebo. That translates into a response rate of 45 percent, compared to 0 percent for placebo.
"The trial data provide "a strong basis to advance this innovative product into Phase III clinical development," commented Duke University Medical Center's John S. Sundy, MD, PhD.
- here's Ardea's release
- check out the Reuters report