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AstraZeneca PLC announces top-line results from phase III programme of lesinurad in combination with xanthine oxidase inhibitors in gout patients


Wednesday, 13 Aug 2014 02:00am EDT 

AstraZeneca PLC:Announces positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, pivotal Phase III clinical trials investigating potential of lesinurad, selective uric acid re-absorption inhibitor (SURI), as combination therapy for treatment of patients with symptomatic gout.Lesinurad is an investigational agent that inhibits 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 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.In CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met primary endpoint, with a statistically higher proportion of patients reaching target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone (p<0.0001).Three most commonly reported adverse events across the CLEAR1 and CLEAR2 trials for patients receiving lesinurad in combination with allopurinol were upper respiratory tract infection, nasopharyngitis and back pain.In CRYSTAL, the three most commonly reported adverse events for patients receiving lesinurad in combination with febuxostat were nasopharyngitis, arthralgia and upper respiratory tract infection.