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TWi Biotechnology completes patient enrollment in AC-201 phase II trial

TWi Biotechnology has completed enrolling patients with acute arthritis of primary gout and elevated serum uric acid in AC-201 phase II trial for gout flare prophylaxis (GFP) during urate-lowering therapy (ULT).

Conducted in eight medical centers in Taiwan, the double-blind, placebo-controlled study randomized 82 patients in 1:1 ratio with 50mg AC-201 or placebo two times each day along with ULT during the treatment period spanning 16 weeks.

TWi Biotechnology president Dr. Calvin Chen said the patient enrollment has been completed before schedule for the AC-201 GFP phase II study.

"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," Chen added.

The orally available small molecule AC-201 is proven to hold back the production and activity of the cytokine IL-1Beta and to down-regulate the IL-1Beta receptors thereby treating diseases such as arthritis and diabetic mellitus.

AC-201 GFP trial chief principal investigator and Taipei Veterans General Hospital division of allergy, immunology, and rheumatology visiting staff Prof. Chung-Tei Chou said, "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."