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news.BioCryst Pharmaceuticals' BCX4208 in conjugation with allopurinol has demonstrated the positive long-term results in the extension phase of its randomized Phase 2b study, evaluating patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of < 6 mg/dL on allopurinol alone.
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BCX4208 is an oral, once-daily novel enzyme inhibitor, and is been studied as an add-on therapy to xanthine oxidase inhibitors to address unmet medical needs in patients with gout.
The 24-week blinded Phase 2b extension trial showed that BCX4208 was safe and well-tolerated, sustained sUA control over time, and generated healthy immune responses to a vaccine challenge at 16 or 20 weeks of treatment.
In the trial, BCX4208 doses of 5 mg, 10 mg, 20 mg and 40 mg/day showed response rates of 40%, 50%, 46% and 55% respectively, compared to 25% for placebo.
BioCryst Pharmaceuticals senior vice president and chief medical officer William P. Sheridan said the sustained efficacy, healthy immune responses to vaccines, and clean safety profile from 900 patient-months of drug exposure in the study supports for Phase 3 trials.