AstraZeneca Presents Phase 3 Results For Lesinurad Combo In Gout

AstraZeneca presented top-line results from two pivotal Phase 3 trials assessing lesinurad in combination with xanthine oxidase (XO) inhibitor allopurinol in patients with gout.

Lesinurad is a selective uric acid re-absorption inhibitor (SURI) that lowers serum uric acid (sUA) levels in the kidney by suppressing the uric acid transporter URAT1 in the kidney and increasing uric acid excretion. The drug in combination with allopurinol was assessed in the two replicate Phase 3 studies CLEAR1 and CLEAR2 in patients with symptomatic gout who are unable to achieve sUA levels while taking their currently prescribed allopurinol dose. Findings show that approximately twice the number of patients reached the target goal of sUA levels when taking the drug combination compared to those who took allopurinol alone.

“We are very encouraged by these data from CLEAR1 and CLEAR2, which demonstrates that combination therapy with lesinurad and allopurinol results in approximately twice as many patients achieving target serum uric levels compared to today’s standard of care allopurinol alone,” said James Mackay, Chief Operating Officer of Ardea Biosciences. Ardea is a company under AstraZeneca responsible for developing the British drug maker’s gout portfolio.

Gout is a serious, inflammatory arthritic disease caused by the metabolic disorder hyperuricemia which, in turn causes crystals to be deposited in the joints and the kidneys, among other tissues. There were roughly 15 million cases of chronic gout diagnosed in 2013, a figure that is projected to balloon to 17.7 million come 2021.

Dr. Kenneth G. Saag, Professor of Medicine at the University of Alabama, Birmingham, Alabama and principal investigator of the study, observes that there has been a lack of promising development for gout treatments in the past 30 years. “The results from this first of its kind large Phase 3 trial demonstrate the potential of combination therapy with lesinurad to provide a future treatment option for gout patients on allopurinol where additional therapy is needed.” AZ said it is preparing to submit regulatory applications for lesinurad combo treatment based on the results.

The company presented the trial findings at the American College of Rheumatology (ACR) 2014 Annual Meeting held in Boston, Massachusetts.