TWi Biotechnology Announces Completion of Patient Enrollment in Gout Flare Prophylaxis Phase II Trial for AC-201

TWi Biotechnology, Inc. today announced that it has completed the 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 8 major medical centers in Taiwan. This study 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 50 mg AC-201 or placebo twice daily in addition to the ULT during the 16-week treatment period.


"We are very pleased to have the patient enrollment completed ahead of schedule for the AC-201 GFP phase II study," said Dr. Calvin C. Chen, President of TWi Biotechnology. "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. We are looking forward to the results of this study which will be available before the end of this year.”


Prof. Chung-Tei Chou, Visiting Staff of Division of Allergy, Immunology, and Rheumatology in Taipei Veterans General Hospital and the Chief Principal Investigator of AC-201 GFP trial also commented “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. AC-201 is an oral medication targeting the IL-1 mediated pathway involved in gout flares. I look forward to seeing positive results from this multicenter clinical trial in Taiwan.”


About AC-201
AC-201 is a first-in-class, orally available small molecule which has shown the ability to inhibit the production and activity of the cytokine IL-1Beta and to down-regulate the IL-1Beta receptors. Inhibition of IL-1Beta signaling has been demonstrated to be effective in treating a variety of diseases including arthritis and diabetic mellitus (DM). The active ingredient of AC-201 has been approved for treating patients with chronic rheumatic diseases in France and subsequently in other EU countries such as Spain and Italy as well as Middle Eastern countries since mid-1990.


TWi Biotechnology holds two US INDs for AC-201 – one for controlling blood glucose in type 2 diabetic patients and the other for gout flare prevention in patients on urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has completed several human clinical trials including two phase II trials with 6 months treatment period demonstrating its satisfactory safety profile.


About Gout
Gout is a disease that results from an overload of uric acid in the body. This overload of uric acid leads to the formation of tiny urate crystals that deposit in tissues of the body, especially the joints. When crystals form in the joints, it causes recurring attacks of joint inflammation (arthritis). It is estimated that there are 6 million people, about 2% of US adult population, suffering from gout.


About TWi Biotechnology, Inc.
TWi Biotechnology, Inc., a fully owned subsidiary of TWi Pharmaceuticals, Inc., is a leading clinical stages biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in the diseases associated with innate immunity . The company is building its product pipeline through in-licensing and internal research. TWi Biotechnology's product development pipeline includes three drug candidates for treating Type II Diabetes, retinopathy, arthritis, and immunodermatology diseases.


Liru Yeh
Head of Investor Relations
Tel: +886-2-2657-3350
email: liru.yeh@twipharma.com