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as mentioned earlier, as a metabolite shed off of its other HIV drug, RDEA806, when that drug gets broken down in the body. Once Ardea figured out that the metabolite was responsible, it made a more potent formulation into a drug called RDEA594. An initial Phase I trial in healthy volunteers showed that the new formulation is much more potent than RDEA806 in its ability to lower uric acid, and the effect is comparable to benzbromarone, another gout drug, which was withdrawn from the market in 2003 by Paris-based Sanofi-Aventis for liver toxicity.
The Ardea drug is thought to work by blocking the ability of kidneys to re-absorb too much uric acid, a different way of working than the standard drug allopurinol, which has been around for decades, Quart says. That means Ardea’s compound and allopurinol ought to be able to work in combination, he says.
Ardea’s candidate has the potential to be given as a once-daily pill to keep patients’ uric acid levels low and to keep patients from getting crystal buildup in joints that can lead to painful flare-ups. FDA approval would likely require a trial in which Ardea shows it can lower uric acid and keep it down at least six months, he says.
One potential snag is that some gout patients on the drug might feel more pain on the Ardea drug before they start feeling better. As their uric acid come down aggressively, the disfiguring bumps in joints, known as tophi, can break down, creating a painful inflammatory response, Quart says. For the first few months on the Ardea drug, until those bumps go away, patients might need to take a combination drug to suppress the inflammation, he says.
These trials don’t look like they will be massive undertakings that will require finding a big pharma partner, so Ardea intends to hold onto 100 percent ownership of the gout drug at least through the final phase of clinical trials, Quart says. There are other biotech companies in early stages of development that also are eyeing gout, including Regeneron Pharmaceuticals. But Quart likes the fact that others seem focused on the inflammatory response to gout, and not the uric acid buildup that his company is tackling. He sounds confident that Ardea can hold its own against whatever comes down the pipeline in the next few years.