BioCryst Pharmaceuticals has revealed positive Phase II Study results for BCX4208, a purine nucleoside phosphorylase inhibitor for the treatment of gout.
The double-blind, randomised, placebo-controlled and multi-centre trial evaluated the urate-lowering activity and safety of BCX4208 alone and in combination with allopurinol.
The primary endpoint of the study was change in serum uric acid concentration from the baseline after 21 days of treatment.
The study involved 87 gout patients with a serum uric acid concentration greater than or equal to 8 mg/dL, who were randomised to receive BCX4208 orally at daily doses of 20mg, 40mg and 80mg as a monotherapy, or in combination with allopurinol orally at daily doses of 100mg, 200mg and 300mg.
Results indicate that a combination of BCX4208 and allopurinol was more effective at reducing serum uric acid concentration compared with either alone.
BCX4208 was generally safe and well-tolerated when administered in combination or alone.
BioCryst plans to conduct a 12-week randomised controlled trial of BCX4208 as an add-on therapy in gout patients who have not adequately responded to allopurinol in early 2011.