Background/Purpose: ABP-671 is a novel, selective and potent URAT1 inhibitor in development for the treatment of elevated serum uric acid (sUA) levels and gout.

Methods: Subjects (N&#3f45) ≥18 and ≤ 55 years, without clinically significant kidney abnormalities on renal ultrasound and non-symptomatic hyperuricemia or gout (two separate fasting sUA results of >7 mg/dL and >24 hours apart) were enrolled. Subjects were randomized to 5 multiple ascending oral dose groups including 1, 2, 4, 6, 12 mg of ABP-671 and placebo in a 7/2 ratio. All subjects underwent a dose escalation dosing period starting from 0.2 mg to 1 mg over a 9-day or 10-day period to mitigate any renal uUA overload. A 7-day dosing period of ABP-671 or placebo followed. The groups were enrolled separately and conducted sequentially (Table 1). TEAEs were reported in 24 (53.3%), including 5 (71.4%), 4 (57.1%), 6 (85.7%), 4 (57.1%), 1 (14.3%), and 4 (40%) in the 1, 2, 4, 6, and 12 mg and placebo groups, respectively. There were no SAEs, grade >3 TEAEs, or deaths. The incidence of AEs was not found dose dependent.GroupDose Escalation PeriodTarget Dose Period1d1 – d3: 0.2 mg, QDd4 – d10: 0.5 mg, QDd11 – d17: 1 mg, QD2d1 – d3: 0.2 mg, QDd4 – d6: 0.5 mg, QDd7 – d9: 1 mg, QDd10 – d16: 2 mg, QD3d10 – d16: 4 mg, QD4d10 – d16: 6 mg, QD 5d10 – d16: 12 mg, QDTable 1: Schedule for dose initiation and target dosing phase

Results: Serum UA (sUA) levels decreased in a dose dependent manner. The max median decrease of sUA occurred at 3.00-9.00 h post dose. For placebo, 1, 2, 4, 6 and 12mg dose groups, the maximum mean sUA decrease in gout subjects was 17.7%, 56.4%, 58.1%, 69.4%, 77.0%, and 79.2% from baseline, and in hyperuricemia subjects, they were 19.9%, 50.1%, 64.1%, 73.2%, 81.2%, and 82.1%. Subjects (%) with sUA levels lower than 6.0, 5.0, and 4.0 mg/dL 24 h post dose were 85.7%, 57.1%, and 14.3% for 1 mg, 100%, 85.7%, and 14.3% for 2 mg, 100%, 85.7%, and 14.3% for 4 mg, 100%, 100%, and 57.1% for 6 mg, and 100%, 100%, and 100% for 12 mg. Table 2. Response rate (N/%) at selected categories 24 h post dose24 h post dose1 mg(n=7)2 mg(n=7)4 mg(n=7)6 mg(n=7)12 mg(n=7)Placebo(n=10)sUA < 6.0 mg/dL6 (85.7)7 (100)7 (100)7 (100)7 (100)0sUA < 5.0 mg/dL4 (57.1)6 (85.7)6 (85.7)7 (100)7 (100)0sUA < 4.0 mg/dL1 (14.3)1 (14.3)1 (14.3)4 (57.1)7 (100)0

Conclusion: ABP-671 has acceptable safety and tolerability in Chinese subjects with hyperuricemia or gout. ABP-671 reduced the sUA in a dose-dependent manner.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-phase-2a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-multiple-ascending-doses-of-abp-671-in-subjects-with-hyperuricemia-or-gout-in-china/