TWi Biotechnology has completed patient enrollment in a phase II trial of AC-201 for Gout Flare Prophylaxis (GFP) during urate-lowering therapy (ULT). This randomized, double-blind, placebo-controlled phase II study is conducted in eight medical centers in Taiwan and includes patients with acute arthritis of primary gout and elevated serum uric acid. A total of 82 patients were randomized at a 1:1 ratio to receive 50mg AC-201 or placebo twice daily in addition to the ULT during the 16-week treatment period.
"This prompt completion signifies the urgent need for an effective and safe drug to reduce the occurrence of gout flare for patients who are receiving ULT,” said Dr. Calvin C. Chen, president of TWi Biotechnology. “Results of this study will be available before the end of this year."
"Starting urate-lowering therapy (ULT) usually triggers painful gout attacks, and there is a need for new therapies to prevent or reduce the occurrence of these flares,” said Chung-Tei Chou, visiting staff of division of allergy, immunology, and rheumatology in Taipei Veterans General Hospital and the chief principal investigator. “AC-201 is an oral medication targeting the IL-1 mediated pathway involved in gout flares."