A DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE PHASE 2A STUDY OF ABP-671, A NOVEL, POTENT AND SELECTIVE URAT1 INHIBITOR, IN PATIENTS WITH GOUT OR HYPERURICEMIA
Authors: Gurwith M et al.
In this randomized, double-blind, placebo-controlled, ascending dose Phase 2a study, 59 patients with gout and 1 with hyperuricemia were enrolled in successive ascending dose groups of 2 mg, 4 mg, or 8 mg ABP-671 daily. Each dose group was subdivided into QD and BID cohorts (10:10) and received ABP-671 oral tablets or placebo in a 4:1 ratio.
At the end of the 4-week dose evaluation period, the mean serum uric acid (sUA) levels were 5.0, 5.3, 3.2, 4.8, 3.1, 3.4 mg/dl for the 1 mg BID, 2 mg QD, 2 mg BID, 4 mg QD, 4 mg BID, 8 mg QD and 9.1 mg/dl for placebo cohorts respectively. Serum uric acid levels (sUA) < 6 mg/dL (= 360 µmol/l) were achieved in 75% in the 1mg BID group and in mostly 100 % in all other dose groups. sUA levels < 5 mg/dL (< 300 µmol/l) were achieved by 37.5% in the 1 mg BID group and 100 % in the 2mg QD, 4 mg QD and BID and 8mgQD groups. ABP-671 was well tolerated at all doses tested. No patient in the placebo group reached a sUA level < 6 mg/dl.
ABP-671 induced stable, statistically significant and clinically meaningful decreases in sUA levels at all doses tested compared to placebo and baseline. At the end of the dose evaluation periods, an average of 87% of the ABP-671 participants attained target sUA level of < 6 mg/dL, compared to 0% of placebo participants. These results support further studies of ABP-671 in a large prospective trial. It would be desirable to have a uricosuric drug beside the xanthine oxydase inhibitors allopurinol or febuxostat in the armamentarium for treating gout.