Phase 2 Outcomes of novel agent Shows Promise Against Tophaceous Gout

The novel URAT1 inhibitor, AR882 exhibited robust and sustained serum urate (sUA) reduction in t Phase 2b trial in treating gout and tophaceous gout. The trial published in American College of Rheumatology evaluated AR882 against the conventional treatment allopurinol in reducing clinically visible tophi in gout patients.

This study involved 42 gout patients with subcutaneous tophi who were randomly assigned to three groups receiving AR882 75 mg, AR882 50 mg + allopurinol, or allopurinol up to 300 mg. Over a period of six months, caliper measurements and Dual Energy Computer Tomography (DECT) were utilized to monitor tophi reduction. The primary endpoint was the change in sUA levels at month 3, with secondary endpoints including resolution of the target tophus area and changes in tophus crystal volume at month 6.

Results demonstrated a remarkable reduction in mean sUA levels across all groups, with the 75 mg AR882 group outperforming others, achieving sUA levels < 6 and < 5 mg/dL in 86% and 64% of patients, respectively.

The AR882 groups exhibited fewer gout flares compared to the allopurinol group. At month 6, AR882 showed complete resolution of at least one tophus in 29% of patients in the 75 mg group, highlighting its efficacy in tophus reduction.

AR882 demonstrated a good safety profile with no serious adverse events related to the treatment. The most frequently reported adverse event was mild gout flare, and no abnormalities were observed in kidney or liver function.

This findings suggest that AR882 may provide some improved and safer alternative for gout treatment. This in turn offers hope to patients with both clinically visible and subclinical crystal deposition. Since this study represents a critical step in the drug's development, the findings pave the way for further investigation, positioning AR882 as a potential game-changer in the management of gout and tophaceous gout.

Source:

Keenan R, WEI J, Morris S, Mundell P, Wei W, Shi K, Shen Z, Hingorani V, Yan S, Kiani B, Yeh L. AR882, an efficacious and selective URAT1 inhibitor for patients with chronic gouty arthritis and subcutaneous tophi: Results from a global, prospective, proof-of-concept trial using dual energy computed tomography. (2023, October 17). ACR Meeting Abstracts.