A Phase 3 trial found the investigational gout drug pozdeutinurad helped more participants reach the serum urate target used in gout care, with adverse-event rates close to placebo.
The American College of Rheumatology (ACR) abstract reports that, at six months, serum urate was below 6 milligrams per deciliter (mg/dL) in 69.2% of participants assigned 75 mg and 56.6% of those assigned 50 mg. The corresponding share in the placebo group was 8.1%; each dose comparison had a p value below 0.0001. The abstract cites less than 6 mg/dL as the treatment target for people with gout.
REDUCE-2 was a global, randomized, double-blind, placebo-controlled Phase 3 study. It assigned 811 participants — 325 each to the 75-mg and 50-mg doses once daily, and 161 to placebo — for 12 months. The ACR abstract says the reduction persisted through the final month. At every assessment, both dose groups had a greater proportion of participants below each of the 5, 4 and 3 mg/dL cutoffs than the placebo group.
The ACR abstract describes pozdeutinurad, also known as AR882, as a selective uric acid transporter 1 (URAT1) inhibitor. It says the drug limits kidney reabsorption of uric acid, supporting its excretion. High serum urate can lead to crystal deposits in joints and other tissues, causing gout flares and joint damage.
Treatment-emergent adverse events were reported in 60.7% of the 75-mg group, 61.7% of the 50-mg group and 60.9% of the placebo group. Treatment-related renal adverse events were reported in 1.8%, 2.2% and 1.2%, respectively.
Sobi quoted Puja P. Khanna, a University of Michigan rheumatology professor and REDUCE-2 investigator, as saying, “The REDUCE-2 results demonstrated clinically meaningful and durable serum urate lowering over 12 months.” The ACR abstract, first published Oct. 20, lists an oral presentation for Nov. 11 from 8:15 to 8:30 a.m. ET.
