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Ardea reports additional results from lesinurad-allopurinol Phase 2b study in hyperuricemia, gout

March 28, 2017

The Company also presented data from a completed preclinical study evaluating lesinurad's effect on the hyperuricemia caused by the commonly used diuretic, hydrochlorothiazide. Hypertension is prevalent in gout patients and they are often treated with anti-hypertensive agents such as thiazide diuretics.  These agents have for some time been known to reduce uric acid excretion from the kidney, and thus increase sUA levels, which can exacerbate the condition of gout patients. The reduction in uric acid excretion by these agents is believed to be due to activation of a uric acid transporter in the kidney known as OAT4.  Results from a completed preclinical study were presented at EULAR showing that lesinurad is an active inhibitor of the OAT4 transporter. This secondary activity may significantly offset the sUA-increasing effects of thiazide diuretics, thereby achieving a secondary benefit for gout patients taking this common treatment for hypertension.  Consistent with these preclinical results, a high level of response was observed with lesinurad in the subset of patients receiving thiazide diuretics in study 203.

Results Presented from Phase 1b Study Evaluating the Combination of Lesinurad and Febuxostat

Final results were also presented from a completed Phase 1b study evaluating the combination of lesinurad and febuxostat (Uloric?, Takeda Pharmaceutical Company Limited; Adenuric?, Ipsen and Menarini) in gout patients with sUA of at least 8 mg/dL.

In this Phase 1b clinical study evaluating the use of lesinurad in combination with febuxostat in 21 gout patients, 100 percent of patients receiving the combination achieved sUA levels below 6 mg/dL, compared to 67 percent and 56 percent for patients receiving 40 mg and 80 mg, respectively, of febuxostat alone. With the highest dose of febuxostat combined with either 400 mg or 600 mg lesinurad, 100 percent of patients reached sUA levels below 4 mg/dL.  No patient achieved these reduced sUA levels on this dose of febuxostat alone. The combination of lesinurad and febuxostat was well tolerated with no serious adverse events or discontinuations due to adverse events.

"While the 28-day results from our 203 Study were encouraging, the high rate of sustained uric acid lowering achieved during the extension period, using the lower doses of lesinurad, are even more impressive," said Barry D. Quart, PharmD, President and Chief Executive Officer of Ardea Biosciences. "Continued dosing with 200 mg produced results similar to those seen at 28 days with higher doses, giving us a wide range of doses to consider for the Phase 3 program."

SOURCE Ardea Biosciences, Inc.