TWi Biotechnology, Inc, a fully owned subsidiary of TWi Pharmaceuticals, has received US FDA and Taiwan FDA approval of a protocol for a phase II clinical trial of its AC-201 controlled-release (CR) tablets for the indications of high blood uric acid level and gout .  The company will start to enroll patients for the phase II clinical trial as soon as possible.

"We are very pleased with the approval of the phase II clinical trial protocol for AC-201 CR.” said Dr. Calvin C. Chen, president of TWi Biotechnology.  “The purpose of this phase II trial is to determine the effectiveness of AC-201 CR in reducing uric acid levels in the blood of gout patients.  This is a joint effort by TWi Biotech and its parent company, TWi Pharma, in applying TWi Pharma’s controlled-release drug delivery platform.  We developed a safer and higher bioavailability formulation than the original instant-release formulations.  The upcoming trial will assess the efficacy and safety of this new formulation.  We hope to provide gout patients a new treatment that can control their uric acid level without worsening the complications of gout.  The currently available drugs either have safety concerns or increase the frequency of gout flares, reducing the compliance of regular drug dosing by patients.  TWi aims to address the unmet needs in the gout therapy, by developing a new treatment that is safer, more effective, and more attractive to patients.”

AC-201 is a first-in-class, small molecule which has shown the ability to inhibit the production and activity of caspase-1 and the cytokine Interleukin-1Beta (IL-1Beta), and to down-regulate IL-1Beta receptors. Inhibition of IL-1Beta signaling has been demonstrated to be effective in treating a variety of diseases including arthritis, gout, and diabetes 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 and Middle Eastern countries such as Spain and Italy since the mid-1990s.

TWi Biotechnology holds two US INDs for AC-201–one for controlling blood glucose in patients with type II diabetes and the other for treating gout in patients undertaking urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has demonstrated safety in mulitple human clinical trials including 3 phase II trials for up to 6 months treatment period.

Gout is a common disease caused by the deposition of monosodium urate (MSU) crystals in patients with hyperuricemia, and characterised by very painful recurrent acute attacks of arthritis. It is estimated there are currently 8.3 million patients in US and the patients population is expected to grow to about 18 million worldwide by 2021. Gout is a potentially curable disease. Unfortunately, the management of gout patients is often insufficient and the patients are underserved. Only 20-30 per cent  of gout patients may be fully adherent to current therapy, primarily due to lack of adequate information and effective management.