Intarcia Therapeutics announced top-line results from two of its four Phase 3 clinical trials for ITCA 650 continuously subcutaneous delivery of exenatide) for patients with type 2 diabetes. Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist is delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump.
The FREEDOM-1 study was a placebo-controlled, double-blind study involving type 2 diabetes patients whose HbA1c was not controlled on diet and exercise alone, or were taking up two or three oral anti-diabetes drugs. Patients with HbA1c levels between 7.5% and 10.0% (n=460) were randomized 1:1:1 to either ITCA 650 40mcg/day, 60mcg/day, or placebo. Participants in the active arms were treated for the first 13 weeks with 3-month devices that delivered an initial dose of 20mcg/day, and then treated with 6-month ITCA 650 at doses of 40mcg/day or 60mcg/day. The primary endpoint was HbA1c reduction over 39 weeks.
FREEDOM-1 demonstrated that ITCA 650 is significantly superior to placebo for both 40mcg and 60mcg 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 trial in type 2 diabetes patients with very high baseline HbA1c levels between 10–12%. All patients in this study were treated with ITCA 650 20mcg/day for the first 3 months and with ITCA 650 60 mcg/day for the next 6 months.
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 <7%.
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 3B studies planned for next year.
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