San Diego’s Ardea Biosciences (NASDAQ: RDEA) said today its experimental gout drug performed no better than existing drugs in an early stage study, but CEO Barry Quart nevertheless said he’s happy with the result.
“This is the first stage of drug development and we have not yet optimized the dose,” Quart said. “We have demonstrated equivalence and that’s a good start.”
As Luke recently reported, Gout is a form of arthritis caused by the build up of uric acid in the joints. The condition affects 3 million to 5 million Americans, most of them men. A decades-old drug called allopurinol is mainstay therapy for gout, but an estimated 60 percent of patients do not respond to it.
A new drug for gout, Takeda’s Uloric, received Food and Drug Administration approval in February. Its highest 80 milligram dose was found to be superior to allopurinol, but it costs significantly more. According to one expert, Dr. Peter Simkin of the University of Washington, allopurinol remains the first treatment choice for patients.
Ardea’s early stage study evaluated doses of 5 milligrams to 600 milligrams of RDEA594, a once-daily oral drug, in 60 healthy volunteers. The company reported those who received the 400-milligram dose experienced a 45 percent drop in uric acid levels after 10 days. The result was similar to what was seen in early stage studies of Uloric, Quart said.
Ardea said no serious side effects were observed in its study. Quart said the relatively safety of the drug means it might be possible to use larger doses to further reduce uric acid levels, although he was pleased with the results. “A 45 percent reduction in healthy volunteers is damn good,” he said.
Ardea is pursuing plans to develop RDEA594 as a first-line therapy over allopurinol—a potentially difficult path. The company expects data from such a study by the end of the year.
The company also is planning another set of clinical studies that will examine RDEA594 as an additional treatment for patients receiving the mainstay therapy. One will study the combination of RDEA594 and allopurinol, and another will test RDEA594 in patients who cannot tolerate or respond to allopurinol.