Positive results from Phase III trial of ITCA 650 in T2D - Intarcia

Interim data from the first 6-months of an ongoing open-label Phase III trial with ITCA 650 (pump delivering exenatide), from Intarcia Therapeutics, showed marked improvements in glycemic control among patients with severe hyperglycemia and longstanding Type 2 Diabetes. Treatment was initiated by placing a 3-month ITCA 650 mini-pump delivering 20 mcg/day, which was then replaced by a 6-month ITCA 650 mini-pump delivering 60 mcg/day for 26 weeks. Mean reductions of HbA1C at Weeks 13 (n=50), 19 (n=39), and 26 (n=25) were -2.5%, -2.9%, and -3.2%, respectively. HbA1C reductions of at least 2% were achieved by 78% of subjects who completed at least 13 weeks of treatment; 50% achieved more than 3% and 22% achieved at least 4% reductions.

HbA1C targets of less than 7% were achieved in 26% of subjects who had completed at least 13 weeks of treatment. Adverse events were consistent with previous trials with ITCA 650. The interim analysis shows ITCA 650 has the potential to dramatically improve glycemic control in patients with severe hyperglycemia and longstanding diabetes. Data were presented at the 74th Scientific Sessions of the American Diabetes Association.