Successful clinical trial results for AstraZeneca's gout drug candidate


AstraZeneca's (NYSE:AZN) gout drug candidate, lesinurad, met its primary endpoint in three separate Phase 3 clinical trials.

In the CLEAR1 and CLEAR2 studies, lesinurad (200 mg and 400 mg once daily) in combination with the xanthine oxidase inhibitor allopurinol met its primary endpoint of a statistically significant higher proportion of patients reaching the target serum uric acid (sUA) goal of >5.0 mg/dL at month 6 compared to allopurinol alone.

In the CRYSTAL study, lesinurad (200 mg and 400 mg once daily) in combination with the xanthine oxidase inhibitor febuxostat in gout patients with tophi met its primary endpoint of a statistically significant proportion of patients reaching the target sUA goal of >5.0 mg/dL at month 6 compared to febuxostat alone for the 400 mg dose, but not the 200 mg dose. The 200 mg does achieved statistical significance at all other time points (months 1-5, 8, 10, 12).

The company plans to present the data at a future scientific meeting and is preparing its regulatory submissions.

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