ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1822

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

Marc Gurwith1, Deon Smith2, Paul Bird3, Jessica Leung4, Mark Bloch5, Joshua Kim6, Rahul Mohan7, Anthony Houston8, Oscar Cumming9, Ann Madrid10, Ullrich Schwertschlag11, Jerry Liu12, Roy Wu13, Jason Xu14, Adam Jin14 and William Dongfang Shi15, 1Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Los Altos Hills, CA, 2Emeritus Research, Melbourne, Australia, 3Emeritus Research Sydney, Sydney, Australia, 4Austin Health, Preston, Victoria, Australia, 5Holdsworth House Medical Practice, Darlinghurst, Australia, 6Paratus Clinical Pty Ltd., New South Wales, Australia, 7Paratus Clinical Pty Ltd, Western Sydney, Australia, 8Peninsula Private Hospital, Kippa-Ring, Australia, 9Novatrials, Kotara, Australia, 10Novotech Australia, Sydney, Australia, 11Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Palo Alto, 12Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Diego, 13Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Francisco, 14Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Suzhou, China, 15Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Fremont

Meeting: ACR Convergence 2022

Keywords: American College of Rheumatology Criteria, gout, hyperuricemia, Randomized Trial, Renal

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Monday, November 14, 2022

Title: Metabolic and Crystal Arthropathies – Basic and Clinical Science Poster

Session Type: Poster Session D

Session Time: 1:00PM-3:00PM

Background/Purpose: ABP-671, a novel selective and potent URAT1 inhibitor reduces reabsorption of uric acid (UA) at the renal proximal tubule, and significantly decreases serum uric acid (sUA) levels in gout or hyperuricemia patients.

Methods: 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 daily (20/group). 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. To moderate rapid increases in urinary uric acid, the dose of study drug was increased gradually in run-in periods of 1 – 3 weeks (1 week for Group 1, 2 weeks for Group 2, and 3 weeks for Group 3). Safety labs, sUA, serum creatinine, adverse events, vital signs, and EKGs were obtained at each visit.

Results: Cohort mean and median sUA decreased rapidly during the run-in period for each of the 6 cohorts and further significantly decreased, proportional to dose, during the 28 days of dose evaluation in comparison with baseline, as shown in the Figure. No significant mean change in the sUA levels in the combined placebo group was observed. After discontinuation of study drug, sUA levels reverted to pre-treatment levels.

At the end of the 4-week dose evaluation period, the mean sUA levels were 5.0, 5.3, 3.2, 4.8, 3.1, 3.4, and 9.1 mg/dL for the 1 mg BID, 2 mg QD, 2 mg BID, 4 mg QD, 4 mg BID, 8 mg QD and combined placebo cohorts, respectively. sUA levels < 6 mg/dL were achieved by 6 [75%] of 8 participants, 5 [62.5%] of 8 participants, 7 [100%] of 7 participants, 7 [87.5%] of 8 participants, 7 [100%] of 7 participants, and 8 [100%] of 8 participants in the 1 mg BID, 2 mg QD, 2 mg BID, 4 mg QD, 4 mg BID, and 8 mg QD cohorts, respectively. sUA levels < 5 mg/dL were achieved by 3 [37.5%] of 8 participants, 3 [37.5%] of 8 participants, 7 [100%] of 7 participants, 5 [62.5%] of 8 participants, 7 [100%] of 7 participants, and 8 [100%] of 8 participants in the 1 mg BID, 2 mg QD, 2 mg BID, 4 mg QD, 4 mg BID, and 8 mg QD cohorts, respectively. sUA levels < 6 mg/dL were achieved by 0 [0%] of 12 in the combined placebo group, as shown in the Table. ABP-671 was well tolerated at all doses tested. Sixteen (26.7%) participants in the combined ABP-671 dosing groups had gout attacks (flares) on study: 3 (18.8%) of 16 participants in Group 1, 6 (37.5%) of 16 participants in Group 2, 5 (31.3%) of 16 participants in Group 3, and 2 (16.7%) of 12 participants in the combined placebo groups. Three (5.0%) participants experienced nephrolithiasis: 1 (2.1%) in the combined ABP-671 groups and 2 (16.7%) in the combined placebo groups.

Conclusion: 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 respective 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. ABP-671 was well tolerated, without evidence of dose limiting toxicity. These results support further studies of ABP-671 in patients with hyperuricemia or gout.

Supporting image 1

Mean sUA from Baseline Visit to Follow-up Visit

Supporting image 2

sUA Categories and Mean/Median sUA Levels after 4 Weeks on Final Dose by Cohort (mITT Population)


Disclosures: M. Gurwith, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; D. Smith, None; P. Bird, None; J. Leung, Novartis, Fresenius Kabi, Eli Lilly, AbbVie; M. Bloch, None; J. Kim, None; R. Mohan, None; A. Houston, None; O. Cumming, None; A. Madrid, None; U. Schwertschlag, Atom Biosciences; J. Liu, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; R. Wu, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Jiangsu Atom Bioscience and Pharmaceutical company Ltd.; J. Xu, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; A. Jin, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.; W. Shi, Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

To cite this abstract in AMA style:

Gurwith M, Smith D, Bird P, Leung J, Bloch M, Kim J, Mohan R, Houston A, Cumming O, Madrid A, Schwertschlag U, Liu J, Wu R, Xu J, Jin A, Shi W. 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 [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/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/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to ACR Convergence 2022

ACR Meeting Abstracts - https://acrabstracts.org/abstract/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/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology