Tigulixostat for lowering uric acid scores high in phase II trial

Treatment with the nonpurine xanthine oxidase inhibitor tigulixostat leads to a significant reduction in serum uric acid (sUA) levels while having an acceptable safety profile, as shown in data from the multicentre, double-blind, parallel-group, dose-finding phase II CLUE trial.

CLUE included 143 patients with gout and hyperuricaemia. They were randomly assigned to receive tigulixostat 50 mg (n=34), 100 mg (n=38), 200 mg (n=37), or placebo (n=34) for 12 weeks. All patients were also given colchicine gout flare prophylaxis.

At week 12, significantly more patients in all tigulixostat dose groups than in the placebo group achieved the primary endpoint of sUA levels <5.0 mg/dL (47.1 percent with 50 mg, 44.7 percent with 100 mg, and 62.2 percent with 200 mg vs 2.9 percent with placebo; p<0.0001).

Treatment with tigulixostat was also associated with a significantly higher mean percentage change in sUA levels at all time points relative to treatment with placebo (from −38.8 percent to −61.8 percent; p<0.0001).

The rate of gout flare requiring rescue treatment ranged from 9.4 percent to 13.2 percent in the tigulixostat and placebo groups.

The frequency of adverse events ranged from 50.0 percent to 56.8 percent across the treatment groups. These events were mild to moderate in severity.