TWi Biotechnology Successfully Completes Patient Recruitment for Phase IIb Trial of AC-201 for the Treatment of Type II Diabetes
TAIPEI, Taiwan, Sept. 7, 2011 /PRNewswire-Asia/ — TWi Biotechnology, Inc. announces the successful patient recruitment for the multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of AC-201 for the treatment of Type II Diabetes. A combined 240 patients from 13 US sites plus 8 Taiwan sites have been enrolled to the trial. With six-month treatment and one-month follow-up, completion of the trial data analysis is expected in the early second quarter of 2012. The trial’s primary endpoint is defined as the change in glycated hemoglobin A1c (HbA1c) from baseline compared to placebo after twenty-four weeks of treatment. In addition, the study is powered to demonstrate additional benefits by monitoring various secondary endpoints including change in lipid profile, change in body weight, change in blood pressure and change in beta-cell function. Meanwhile, by measuring various biomarkers such as interleukin-1Beta, interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-Alpha, high-sensitivity C-reactive protein, plasminogen activator inhibitor-1, transforming growth factor-Beta, and adiponectin, the company is able to stratify different patient groups in terms of clinical response, so as to develop personalized, preventive or therapeutic strategies.
“Through careful planning and execution, we are pleased with the efficient manner in which the twenty-one clinical sites, thirteen in US and eight in Taiwan, have enrolled 240 patients in the phase IIb study within 5 months since its inception, which is 4-month ahead of the expected schedule,” stated Dr. M. Sherry Ku, President & CSO of TWi Biotech. “During the previous Phase IIa study, those patients with inadequate blood glucose control by multiple 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. With the positive Phase IIa data and successful completion of enrollment of Phase IIb trial, we are confident that this study shall keep us on track of our projected development timeline for AC-201 and we believe AC-201 will be the first-in-class oral small molecule IL-1Beta inhibitor for treating Type II Diabetes to reach the market. For the future development strategy, we are planning to collaborate with a global partner developing AC-201 as an add-on therapy for the treatment of Type II Diabetes and explore the additional benefits of AC-201 in helping diabetic patients such as protection of kidney function and prevent further cardiovascular events that are major complications for diabetic patients.”
AC-201 is the only orally available small molecule modulating the cytokine synthesis of IL-1Beta and in post-transcription and post-translation stage. Reduction of IL-1Beta has been demonstrated to be effective in treating a variety of inflammatory diseases including Arthritis, Diabetic Nephropathy (DN) and Diabetic Mellitus (DM).
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 cancer and dermatology diseases.
SOURCE TWi Biotechnology, Inc.