(Source: PBR 2014-12-15）
TWi Biotechnology has received approval from the US Food and Drug Administration (FDA) and Taiwan FDA for a protocol of a Phase II clinical trial of its first-in-class, small molecule AC-201 controlled-release (CR) tablets for the indications of high blood uric acid level and gout.
Patient enrollment in the Phase II clinical trial will be initiated as soon as possible, according to the company.
AC-201 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 showed to be effective in treating diseases such as arthritis, gout and diabetes mellitus (DM).
TWi Biotechnology president Dr Calvin Chen said: “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.
“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.”
The company holds two US investigational new drug (IND) applications for AC-201, one for controlling blood glucose in patients with type II diabetes, while the other for treating gout in patients undertaking urate-lowering therapy.
Apart from the good safety record of its active ingredient used in treating another chronic disease, AC-201 has also showed safety in multiple human clinical trials including three Phase II trials for about six months treatment period.
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