TAIPEI, Oct. 27, 2015 /PRNewswire/ -- TWi Biotechnology, Inc., today announced that it has received Notice of Allowance for AC-201, TWi Biotechnology's lead drug candidate, from the Korean Intellectual Property Office for the patent application numbered 10-2012-7029213. This patent includes AC-201 or its pharmaceutically acceptable salts or active metabolites for treatment of both type I and type II diabetes. The patent also covers the methods of treatment using AC-201 for type II diabetes, and provides a protection period up to year 2030. This patent adds to TWi Biotechnology's broad intellectual property portfolio for AC-201. This patent has been allowed in US, Mexico, New Zealand, China and Russia.
"We are very pleased with the allowance of our patent application in Korea for AC-201. These new patents combined will provide TWi Biotechnology intellectual property protection for AC-201 in addressing unmet medical needs as an effective treatment for type I and II diabetes." said Dr. Calvin C. Chen, President of TWi Biotechnology. "AC-201 has demonstrated its efficacy in reducing HbA1c levels in patients with type II diabetes in two phase II clinical trials. In addition, due to its unique mode of action in inhibiting the activation of the inflammasome, AC-201 has the potential to protect the vital organ damage associated with diabetes. We hope the drug candidate AC-201 will continue its development in Asia including Korea and will bring benefits to the vast number of diabetes patients in Asia after it obtains drug approval."
AC-201 is a first-in-class small molecule which has shown the ability to inhibit the activation and production of the inflammasome, caspase-1, and the cytokine interleukin-1Beta (IL-1Beta), and to down-regulate IL-1Beta receptors. Inhibition of the inflammasome and 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 multiple human clinical trials including 3 phase II trials for up to 6 months treatment.
About Type II Diabetes
Diabetes is one of the most common metabolic diseases worldwide. The World Health Organization (WHO) has defined type II diabetes as a result of the body's ineffective use of insulin. Type II diabetes comprises 90% of people with diabetes around the world, and is largely caused by excess body weight and physical inactivity. According to The 6th Edition of the International Diabetes Federation (IDF) Diabetes Atlas, 382 million people live with diabetes worldwide (8% of the world population), which is expected to affect 592 million by 2035.
About TWi Biotechnology, Inc.
TWi Biotechnology, Inc., a subsidiary of TWi Pharmaceuticals, Inc., is a leading clinical stage biopharmaceutical company based in Taipei, Taiwan, specializing in the development of innovative new drugs for unmet medical needs, especially in 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 two drug candidates for treating type II diabetes, arthritis, and immunodermatology diseases.
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SOURCE TWi Pharmaceuticals, Inc.