Positive Results from Phase IIa Study Pave Way for Phase IIb Trial of AC-201 for the Treatment of Type II Diabetes
TAIPEI, Taiwan, June 14, 2011 /PRNewswire-Asia/ — TWi Biotechnology Inc. announced today that the company has enrolled over 50% of the total 240 patients for the Phase IIb clinical trial of AC-201 for the treatment of Type II Diabetes. The randomized, double-blind, placebo-controlled, dose-ranging, multi-center study is primarily designed to evaluate the glycated hemoglglobin A1c (HbA1c) lowering effects of AC-201 in patients with Type II Diabetes Mellitus. Meanwhile, the cardiovascular safety profile will be carefully monitored according to U.S. FDA’s guidance. In addition to primary objective, by measuring various biomarkers, the company is able to stratify different patient groups in terms of clinical response, so as to develop personalized, preventive or therapeutic strategies.
“The initiation of Phase IIb study is a major milestone for TWi Biotechnology as we continue to demonstrate the potential efficacy of AC-201,” stated Dr. M. Sherry Ku, President & CSO of TWi Biotech. “During the previous Phase IIa study, those patients with inadequate blood glucose control by up to three drug combinations of currently available oral anti-diabetic drugs were treated with AC-201 as an add-on therapy. The Phase IIa proof-of-concept study showed a mean reduction of 0.63% for HbA1c (N=56, p<0.05) at the end of 24 weeks treatment period, which is very promising and encouraging. The detailed results of the Phase IIa study will be presented in the American Diabetes Association (ADA) 71(st) Annual Meeting Scientific Sessions (June 24-28, 2011) in San Diego, California, USA. With the positive Phase IIa results, we are confident to begin enrolling patients for Phase IIb study in March 2011. As of today, we have enrolled more than 50% of the total 240 patients in U.S. and Taiwan. We are expecting to complete patient enrollment by the end of this year. Our plan is to develop AC-201 as an add-on therapy and/or as a mono therapy for Type II Diabetes.”
About TWi Biotechnology
TWi Biotechnology, Inc. (www.twipharma.com) is a leading biopharmaceutical company based in Taipei, Taiwan. The company is specializing in in-licensing and developing innovative new drugs for unmet medical needs. With the solid experience in regulatory affairs and clinical development, the company can expedite the development process of drug candidates for worldwide market. The company is building its product pipeline through in-licensing of late pre-clinical stage drug candidates from renowned pharmaceutical companies and research/academic institutions. The company has three active therapeutic candidates to treat Type II Diabetes complications, retinopathy, and cancer.
SOURCE TWi Biotechnology, Inc.