Selective urate transporter 1 inhibitor shows promise in hyperuricaemia

The highly selective urate transporter 1 inhibitor SHR4640 has demonstrated superior serum uric acid (sUA)-lowering effect in Chinese patients with hyperuricaemia as compared with placebo, a phase II study has shown.

The randomized double-blind dose-ranging phase II study enrolled 197 patients with sUA levels ≥480 µmol/l and had gout, or sUA levels ≥480 µmol/l without gout but with comorbidities, or sUA levels ≥540 µmol/l. About 99.5 percent of the cohort were men, and 95.9 percent had gout history.

Patients were evenly randomized to receive once daily 2.5 mg/5 mg/10 mg of SHR4640, 50 mg of benzbromarone, or placebo, respectively.

The proportion of patients achieving target sUA level of ≤360 µmol/l at week 5, the primary study endpoint, was 32.5 percent with 5-mg SHR4640, 72.5 percent with the 10-mg dose, and 61.5 percent with benzbromarone. These numbers were significantly higher compared with that in the placebo group (0 percent; p<0.05 for both active treatment dose groups).

Furthermore, sUA dropped by 32.7 percent with 5-mg SHR4640, 46.8 percent with the 10-mg dose, and 41.8 percent with benzbromarone as compared to a mere 5.9-percent decrease with placebo (p<0.001 for each comparison).

The frequency of incident gout flares requiring intervention was similar in all treatment groups, as was the rate of treatment-emergent adverse events (TEAEs). There were no serious TEAEs reported.