TWi Biotechnology, a fully owned subsidiary of TWi Pharmaceuticals, has received an official notification of patent allowance related to its lead drug candidate, AC-201, from China State Intellectual Property Office of Patent. The granted patent claims cover AC-201's composition of matter and uses to treat various inflammatory/autoimmune diseases such as Type I/II diabetes, osteoarthritis and the complications of these diseases. The patent is part of TWi Biotechnology's broad intellectual property portfolio for AC-201.
AC-201 has demonstrated efficacy in reducing HbA1c levels in Type II diabetes patients in two Phase II trials with six month treatment periods. TWi Biotechnology will be presenting the results of a 259-patients multinational Phase IIb study at the American Diabetes Association 73rd Scientific Sessions, to be held from 21st to 25th June, in Chicago, IL. AC-201 is a first-in-class, orally-available small molecule that has shown the ability to inhibit the production and activity of the cytokine interleukin (IL)-1beta and to down-regulate the IL-1beta receptors. 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 mid-1990.
TWi Biotechnology holds two US INDs for AC-201; one for controlling blood glucose in Type II diabetes patients and the other for gout flare prevention in patients under urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has gone through several clinical trials with a satisfactory safety profile.