TWi Pharmaceuticals, Inc., a specialty pharmaceutical company based in Taiwan, today announced its fully owned subsidiary, TWi Biotechnology, Inc. has completed a multinational phase II dose-ranging study of AC-201, an orally available IL-1 Beta modulator, in 259 patients with type II diabetes uncontrolled on up to three oral medications. In the intent-to-treat population, AC-201 showed placebo-corrected reductions in HbA1c of 0.20%, 0.29%, and 0.35% (indicates statistical significance with p<0.05) after 24 weeks of treatment in the three tested dose groups of 25 mg, 50 mg, and 75mg twice daily (b.i.d), respectively. In the per-protocol population, the placebo-corrected reduction in HbA1c was 0.37%, 0.42%, and 0.49%, for 25 mg, 50 mg, and 75 mg b.i.d dose groups, respectively. AC-201 showed good dose response and was well tolerated up to 75 mg b.i.d. The most frequent side effect was diarrhea that was mostly mild.
The clinical trial was conducted in the United States, where 150 patients were enrolled in 13 sites, and Taiwan, where 109 patients were enrolled in 8 sites. Further analysis revealed that AC-201 in the US cohort demonstrated placebo-corrected HbA1c reductions in the per-protocol population of 0.61%, 0.72%, and 0.93%, for 25 mg, 50 mg, and 75mg b.i.d dose groups, respectively. The differences in patient profiles such as BMI (mean baseline of 27 kg/m square in Taiwan vs. 32kg/m square in the US), background anti-diabetic therapy (54% in Taiwan vs. 9% in the US of patients taking 3 oral anti-diabetic drugs), and medical practices between the two cohorts are possible reasons for the differences in efficacy results.