ITCA 650: Phase III data

The double-blind, U.S. Phase III FREEDOM-1 trial in 460 Type II diabetics with an HbA1c of 7.5-10% not controlled on 0-3 oral diabetes drugs showed that once-daily 40 and 60 Ug doses of ITCA 650 each met the primary endpoint of reducing HbA1c from baseline to week 39 vs. placebo. Intarcia said ITCA 650 led to mean reductions in HbA1c from baseline to week 39 of 1.4-1.7%. Both doses of ITCA 650 also met all secondary endpoints vs. placebo, including changes in weight and the proportion of patients achieving an HbA1c of <7%. ITCA 650 was well tolerated. Intarcia said the data will be submitted for presentation at the American Diabetes Association meeting in Boston in June. ...