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NAPSR News: AstraZeneca Obtains Positive Results from Phase III Trials For The Treatment of Gout

AstraZeneca’s Phase III program of lesinurad in combination with xanthine oxidase inhibitors produced optimistic results for gout patients. If approved, this combination therapy will add a significant boost to the company’s product pipeline.

 
PRLog - Aug. 13, 2014 - WASHINGTON -- Astra Zeneca has announced positive results from their Phase III clinical trials CLEAR1, CLEAR2 and CRYSTAL investigating leisnurad as a prospective combination therapy for the treatment of patients with gout. The trials were conducted by Ardea Biosciences, a wholly-owned subsidiary of AstraZeneca. Lesinurad’s main function is to impede the URAT1 transporter which increases uric acid excretion thereby lowering serum uric acid (sUA) which normalizes acid excretion.

CLEAR1 and CLEAR2  trials studied lesinurad (200mg and 400mg once daily) in combination with the xanthine oxidase (XO) inhibitor allopurinol. The combination of such therapies met the primary endpoint and the clinical results revealed a high statistical number of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone (p<0.0001).

CRYSTAL trial combined lesinurad (200mg and 400mg once daily) with the XO inhibitor febuxostat (80mg once daily) in gout patients with tophi  (small lumps forming under the skin). The results from this trial displayed clinical significance compared to the placebo. Patients reached the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone (p<0.0001).

“Gout is a serious, chronic and debilitating inflammatory disease. There is a significant unmet need, with 40 to 70 percent of gout patients not reaching target levels of serum uric acid with the current standard of care,” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer. “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.”

Based on the results from the Phase III trials, AstraZeneca is proceeding with preparation of regulatory submissions for lesinurad (200mg) combination therapy. If successful, AstraZeneca will secure a spot as a significant player in the worldwide market for gout with this treatment.

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