ITCA 650 meets primary endpoints in Phase III trial for T2D - Intarcia

Intarcia Therapeutics has announced successful top-line results from two of its four Phase III clinical trials for ITCA 650 (exenatide, delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump), in patients with Type 2 Diabetes. FREEDOM-1, which tested the efficacy and safety of ITCA 650 against placebo, demonstrated ITCA 650 to be significantly superior to placebo for both 40 mcg and 60 mcg doses, and met all its clinical endpoints. Also, pre-specified sub-group analyses showed substantial improvement in hyperglycemia across a wide spectrum of patients and background medications.

The second trial, FREEDOM-1 HBL (High Baseline), was an open-label Phase III clinical trial in Type 2 Diabetes patients with very high baseline HbA1c levels between 10-12%. The 39-week (9-month) results showed a sustained reduction of 3.4% in HbA1c among these poorly controlled patients. The HBL study also showed the ability of a 39-week therapy with ITCA 650 to bring 25% of these patients, many uncontrolled on multi-drug therapy, to their HbA1c goal of less than 7%.

The full findings for both trials will be submitted at the 2015 American Diabetes Association (ADA) annual meeting. If approved, ITCA 650 would be the first and only injection-free GLP-1 therapy to deliver up to a full year of treatment in a single subcutaneous mini-pump. Both 6-month and 12-month mini-pumps are in full development for ongoing and additional Phase IIIB studies planned for next year.