AC-201: Phase IIb data

Data from 259 Type II diabetics inadequately controlled on up to 3 anti-diabetic drugs in the intent-to-treat (ITT) population of a double-blind, U.S. and Taiwanese Phase IIb trial showed that twice-daily 75 mg oral AC-201 met the primary endpoint of reducing mean HbA1c from baseline to week 24 vs. placebo (0.13% vs. a gain of 0.22%, p<0.05). The twice-daily 25 and 50 mg doses of AC-201 missed the endpoint. Specifically, low-dose AC-201 increased HbA1c by 0.03%, while mid-dose AC-201 reduced the endpoint by 0.07%. In the per protocol (PP) population (n=184), mid- and high-dose AC-201 significantly reduced HbA1c by 0.27% and 0.34%, respectively, vs. a gain of 0.15% for placebo (p<0.05 for both). Low-dose AC-201 non-significantly reduced the endpoint in the PP population by 0.22%. The PP population consisted of all randomized patients who received >=1 dose of AC-201 or placebo and who completed the 24-week, double-blind treatment period without any major deviations from the study protocol. AC-201 was well tolerated with diarrhea reported as the most common adverse event. ...