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news.BioCryst Pharmaceuticals has initiated a Phase 2b study of BCX4208 as an add-on therapy in patients with gout who have not responded to allopurinol therapy alone.
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The randomised, double-blind, dose-response study is designed to assess the safety and efficacy of BCX4208 in combination with allopurinol in patients who have not reached the serum uric acid (sUA) objective of <6 mg/dL following treatment with allopurinol 300 mg alone.
The primary endpoint of the study will be the proportion of subjects with sUA <6 mg/dL at day 85.
The study will enroll 250 patients and will evaluate BCX4208 at doses of 5mg, 10mg, 20mg, 40mg and placebo administered once-daily for 12 weeks, in combination with allopurinol’s standard dose of 300 mg.
BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor, which has the potential to address unmet medical needs across a broad range of inflammatory and autoimmune diseases.