Positive phase III data from two studies of ITCA 650 (exenatide subcutaneous) in type 2 diabetes-Intarcia Therapeutics

Intarcia Therapeutics announced results from its first two Phase III clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide subcutaneous osmotic mini-pump) in patients with type 2 diabetes.

In FREEDOM-1, ITCA 650 produced significant and sustained mean reductions in HbA1c of 1.4% at 39 weeks of treatment (mITT population). Two pre-specified patient populations were assessed to determine how HbA1c reductions might vary based on whether or not patients were on a background regimen including a sulfonylurea (SU) therapy. Patients primarily on background metformin (~40% of patients), or diet and exercise (~11% of patients), showed a mean HbA1c reduction of 1.7%. Those on an SU-based background regimen (47% of patients) had a mean HbA1c reduction of 1.2%. In addition, significant and progressive dose-dependent weight loss was observed over 39 weeks (mITT population).

Highlights from the FREEDOM-1 HBL study include, notably, significant reductions in HbA1c levels were achieved by week 6, a period during which patients were receiving only the initial 20 mcg/d ITCA 650 dose. The change from baseline was sustained over time, with patients achieving a mean reduction in HbA1c of 3.4% at week 39. In addition, 22% of patients achieved HbA1c reductions of 4% or greater and 25% of patients achieved an HbA1c level <7% at the locf endpoint. weight reduction was observed in the trial but the results were not statistically significant. data were presented at the 51st european association for the study of diabetes easd meeting.>