13th Aug 2014 06:43
LONDON (Alliance News) - AstraZeneca PLC said Wednesday it has seen positive top-line results from Phase III clinical trails of combination treatments of its compound lesinurad with xanthine oxidase inhibitors for the treatment of patients with symptomatic gout.
The first two trials investigated the potential of a lesinurad combination with xanthine oxidase inhibitor allopurinol in patients not meeting target levels of serum uric acid. In both of these trials the combination met its primary endpoint at both a 200 milligram and 400 milligram dose.
The third trial investigated a lesinurad combination with xanthine oxidase inhibitor febuxostat for gout patients with tophi, meaning visible nodules of uric acid crystals that are deposited in joints and skin. In this trial, the combination met its primary endpoint at a 400 milligram dose. However at a 200 milligram dose did not meet the endpoint of a "statistically significant" higher proportion of patients reaching the target serum uric acid goal at month six.
However, AstraZeneca noted that the 200 milligram dose was superior to a placebo combined with febuxostat at all other time points it measured.
"These data indicate that combination therapy with lesinurad may be a potential treatment option for gout patients," said Briggs Morrison, executive vice president of global medicines development and chief medical officer.
AstraZeneca said it is beginning the preparation of regulatory submissions for combination therapy using lesinurad at a 200 milligram dose.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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