BioCentury
ARTICLE | Clinical News

ITCA 650: Phase III data

May 16, 2016 7:00 AM UTC

Top-line data from the double-blind, international Phase III FREEDOM-CVO cardiovascular outcomes trial in >4000 Type II diabetics showed that once-daily 60 ug ITCA 650 plus standard of care (SOC) met the primary endpoint of non-inferiority to placebo plus SOC in the time to first occurrence of a MACE, defined as CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina. Intarcia said the primary objective used a meta-analysis of FREEDOM-CVO and the 3 other Phase III trials of ITCA 650 in the FREEDOM program (see BioCentury, Oct. 6, 2014; June 15, 2015 & Aug. 24, 2015). The pre-defined non-inferiority margin was an upper bound of a 2-sided 95% CI of 1.8, but the company did not disclose detailed data. There were 160 MACE events reported in FREEDOM-CVO. ...