Lesinurad success in CLEAR 1, CLEAR 2 and CRYSTAL studies for Gout - AstraZeneca

AstraZeneca announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic Gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid (sUA).

CLEAR1 and CLEAR2 studied lesinurad (200mg and 400mg once daily) in combination with the xanthine oxidase (XO) inhibitor allopurinol, in symptomatic Gout patients not achieving target sUA levels on their current allopurinol dose. CRYSTAL studied lesinurad (200mg and 400mg once daily) in combination with the XO inhibitor febuxostat (80mg once daily) in Gout patients with tophi (visible nodules of uric acid crystals that are deposited in joints and skin).

In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg dl at month 6 compared to allopurinol alone p><0.0001). in the crystal trial lesinurad 400mg in combination with febuxostat met the primary endpoint with a statistically significant higher proportion of patients reaching the target sua goal of><5.0mg dl at month 6 compared to febuxostat alone p><0.0001). although lesinurad 200mg did not achieve statistical significance at month 6 p="0.13)," this dose in combination with febuxostat was superior to placebo plus febuxostat at all other time points measured at months 1 to 5 8 10 and 12 nominal p><0.05).>