RDEA 594 meets primary endpoint in Gout study-AstraZeneca

AstraZeneca and Ardea Biosciences have announced top-line results from LIGHT, a Phase III study investigating RDEA 594 (lesinurad) as a monotherapy in Gout patients who cannot take xanthine oxidase inhibitors allopurinol or febuxostat. Lesinurad met the primary endpoint with a statistically significant higher proportion of patients meeting the sUA goal of more than 6.0 mg/dL at 6 months compared with patients on placebo. Patients treated with lesinurad monotherapy were more likely to experience serum creatinine elevations and renal adverse events, including serious events, compared to patients on placebo. Other commonly reported adverse events in patients treated with lesinurad were diarrhoea, nausea and constipation.

The other Phase III trials in the programme are investigating lesinurad in combination with allopurinol in patients not reaching target sUA levels on allopurinol alone (CLEAR1 and CLEAR2) and as a combination therapy with febuxostat in patients with tophaceous Gout (CRYSTAL). The results of these studies are expected in mid 2014, and regulatory submissions in the US and EU are expected in the second half of 2014.