Ardea Sees Early Signs of Effectiveness With Gout Drug

Xconomy San Diego — 

Ardea Biosciences, the San Diego-based developer of a treatment for gout, has shown in a small clinical trial that a treatment its scientists stumbled upon by accident just might work.

Ardea (NASDAQ: RDEA) said today that 6 of the first 7 patients who got its lead drug candidate for gout were able to bring their uric acid levels down to a medically acceptable target level in the blood after eight days. That’s an indicator that uric acid shouldn’t build up in the joints and cause intensely painful crystals. None of the four patients on a placebo so far achieved that benchmark, and two out of three did on a standard dose of allopurinol, Ardea said in a statement. The Ardea drug was well-tolerated, and no patients dropped out because of side effects, the company said.

The latest findings add to some encouraging, albeit preliminary findings, the company released in April. Those results showed that the Ardea drug, RDEA594, a once-daily oral pill, passed a safety study of 60 healthy volunteers, and a mid-stage study in patients showed a 45 percent drop in uric acid levels after 10 days. The drug was initially studied for HIV, until researchers noticed its surprising effect against gout. Now if these findings can be confirmed in larger trials, it could provide a new treatment option. This disease affects 3 million to 5 million Americans, most of whom don’t respond to the standard allopurinol.

The early results “are very encouraging and provide a strong basis for moving RDEA594 into larger Phase 2b studies,” said John Sundy, an inflammatory disease expert at Duke University Medical Center and a member of Ardea’s scientific advisory board, in a company statement.

Ardea stock has climbed from $9.30 a share the day it released preliminary results of the first two trials on April 20, to $15.24 at yesterday’s close. The company plans to complete major parts of a larger, Phase 2b clinical trial of the drug before the end of the year, said Barry Quart, Ardea’s CEO, in a statement.