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news.AstraZeneca has released 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 to treat patients with symptomatic gout.
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Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby reduces serum uric acid (sUA).
The CLEAR1 and CLEAR2 trials 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.
The CRYSTAL trial assessed lesinurad (200mg and 400mg once daily) in combination with the XO inhibitor febuxostat (80mg once daily) in gout patients with tophi.
In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, while in the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint.
Although lesinurad 200mg did not achieve statistical significance at month six, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points.
AstraZeneca Global Medicines Development executive vice-president and chief medical officer Briggs Morrison said gout is a serious, chronic and debilitating inflammatory disease.
"There is a significant unmet need, with 40% to 70% of gout patients not reaching target levels of serum uric acid with the current standard of care," Morrison said.
"We are encouraged by our initial review of the top-line results from the CLEAR1, CLEAR2 and CRYSTAL studies which provide important new information on the efficacy and safety of lesinurad in combination with febuxostat and allopurinol.
"These data indicate that combination therapy with lesinurad may be a potential treatment option for gout patients."
Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.