TWi Biotechnology Inc. announced that it has completed patient enrollment in its Phase 2 clinical trial (Study code: AC-201-GOU-002) of AC-201CR for the treatment of gout. The company expects to report top-line results from this study in the fourth quarter of 2016. The positive interim results of this proof-of-concept study were delivered in December, 2015. TWiB launched its Phase 2 clinical study of AC-201CR for the treatment of gout in November 2014. The multi-center, double-blind, randomized, placebo-control Phase 2 study under US IND is being conducted in Taiwan, and is designed to evaluate AC-201CR's efficacy, safety and tolerability in up to 127 individuals with gout. Efficacy is measured based on American College of Rheumatology Guidelines for Management of Gout which includes measurements of serum urate level and gout flare number. This Phase 2 study is also evaluating multiple secondary endpoints, including metabolic/inflammation markers and safety. The 12-week AC-201CR treatment period was composed of 3 periods of 4 weeks each with escalating treatment. In Period 1, subjects with gout and hyperuricemia were randomized at a 1:1 ratio to receive AC-201CR or placebo. In Period 2, subjects continued blinded study medication and initiated a urate-lowering therapy (ULT) of febuxostat 40 mg once daily. In Period 3, the ULT of subjects with sUA still over 6 mg/dL were titrated up to 80 mg febuxostat QD. For other subjects, the ULT was maintained until the end of the study. At Week 12, subjects discontinued blinded study medication but maintained their dose of febuxostat for a 4-week follow-up period.