Global biopharmaceutical company Sobi has announced positive late-breaking results from the Phase 3 REDUCE-2 study of pozdeutinurad (AR882), an investigational once-daily oral URAT1 inhibitor being developed for patients with uncontrolled gout. The findings demonstrated sustained reductions in Serum Urate (SU) levels over 12 months, with a safety profile generally comparable to placebo.
The global study involved 811 patients randomised to receive pozdeutinurad 75 mg, 50 mg or placebo. It met its primary endpoint, with 69.2 per cent of patients receiving the 75 mg dose and 56.6 per cent receiving the 50 mg dose achieving SU levels below 6 mg/dL at month six, compared with 8.1 per cent in the placebo group.
Reductions in serum urate were observed as early as month one and sustained through month 12. Treatment-emergent adverse events were reported in 60.7 per cent, 61.7 per cent and 60.9 per cent of patients receiving the 75 mg dose, 50 mg dose and placebo, respectively.
Puja P. Khanna, Professor of Medicine at the University of Michigan and REDUCE-2 investigator, said the findings demonstrated sustained urate reduction and highlighted the potential of pozdeutinurad as a treatment option for patients with uncontrolled gout.
Pozdeutinurad remains an investigational treatment and has not been stated as approved for commercial use.
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