San Diego’s Ardea Biosciences (NASDAQ: [[ticker:RDEA]]) appears to have stubbed a toe in its development of RDEA 594 as a first-line treatment for gout. Data presented at a medical meeting in Philadelphia today showed the Ardea drug was no better at controlling gout than existing medications, including allopurinol, a cheap generic. During a conference call with investors today, CEO Barry Quart says Ardea’s chief focus is on developing RDEA 594 as an add-on or alternative for patients who do not respond adequately to existing drugs. Quart says the potential market for RDEA 594 remains quite large since 60 percent of gout patients do not fully improve on the mainstay drug allopurinol.
Ardea is testing its drug in combination with allopurinol and in combination with febuxostat, a newer drug marketed by Takeda under the name Uloric, Quart said. A mid-stage trial pitting RDEA 594/allopurinol against allopurinol alone in gout patients is now underway, with data expected by the end of the year. Development of the febuxostat/RDEA 594 combination is not as far along; an early-stage study is being conducted in 54 healthy volunteers to look at the safety of the drug combination. If results are good, Ardea will test the drug combination in people with gout. Quart said animal studies to date have supported the safety of the drug combinations.
Adrea still believes RDEA 594 may be useful as a standalone treatment for people who can’t tolerate or don’t benefit from allopurinol. However, developing RDEA 594 as a monotherapy is not a major focus, according to the company. “We have to be realistic,” said Ardea spokesman John Beck, noting the company has been shifting the focus of its development program for “the last couple quarters.”
Quart’s comments came as Ardea presented fresh data from clinical studies of RDEA 594 at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals. Data from a small trial of 21 gout patients shows