Taiwan-based drug development company TWi Biotechnology (TWiB) has completed enrolling patients in its Phase II clinical trial of AC-201CR for the treatment of gout.
AC-201CR is the controlled release oral formulation version of AC-201, an orally administered small molecule inhibiting URAT1, as well as the production and activity of caspase-1 and the cytokine interleukin-1Beta (IL-1Beta).
The Phase II clinical trial, launched in 2014, is a multi-centre, double-blind, randomised, placebo-control study conducted in Taiwan involving 127 patients with gout.
The trial involved a 12-week AC-201CR treatment period, which dedicated three periods of four weeks each with escalating treatment.
It is aimed at determining the efficacy, safety and tolerability of AC-201CR while treating patients.
Efficacy is determined on the basis of American College of Rheumatology Guidelines for Management of Gout, which measures the serum urate level and gout flare number.
The trial is also aimed at determining multiple secondary endpoints, which are metabolic / inflammation markers and safety of AC-201CR.
TWiB CEO Calvin Chen said: "Following a successful interim analysis that showed 89% of patients reached a treatment target of serum uric acid concentration below 6 mg/dL at Week 8 combining AC-201CR and 40mg febuxostat relative to 67% of those taking 40 mg febuxostat alone, we are very pleased to have accomplished this clinical milestone for TWiB and are looking forward to completing the treatment phase of this study and releasing top-line data in the fourth quarter of this year."
AC-201 inhibits both URAT1 and cytokine interleukin-1Beta (IL-1Beta) by blocking the assembly of the NLRP3 inflammasome.
An inhibited NLRP3 inflammasome has proven to be effective in diseases such as arthritis, gout, and diabetes mellitus (DM).
Image: X-ray of left foot depicting gout. Photo: courtesy of Hellerhoff via Wikipedia.