Intarcia's ITCA 650 tops Januvia in Phase III trial

Intarcia Therapeutics Inc. (Boston, Mass.) said ITCA 650 met the primary endpoint of superiority to Januvia sitagliptin in reducing HbA1c, as well as all secondary endpoints, in a Phase III trial to treat Type II diabetes. The results triggered a $100 million milestone payment to Intarcia.

In the 535-patient FREEDOM-2 trial, patients receiving 60 ug/day ITCA 650 showed a 1.5% decrease in HbA1c after 52 weeks, the primary endpoint, compared to 0.8% in patients receiving 100 mg/day Januvia (p<0.001). The ITCA 650 group also had significantly greater weight loss than the Januvia group (4 kg vs. 1.3 kg; p<0.001), and significantly more patients receiving ITCA 650 had weight loss of 2 kg or more and had glucose reductions of more than 0.5%, meeting secondary endpoints. ...