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Positive Phase III Results Reported for Exenatide in Treatment of Type-2 Diabetes

Subcutaneous ‘mini-pump’ delivers therapy once or twice yearly

Positive results have been reported from two phase III clinical trials of exenatide (Inarcia Therapeutics), delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump. The first trial, FREEDOM-1, was a double-blind, placebo-controlled study that evaluated the efficacy and safety of exenatide compared with placebo in patients with type-2 diabetes.

Subjects enrolled in this trial had hemoglobin A1c (HbA1c) measures of between 7.5% and 10.0%. A total of 460 patients were randomly assigned to receive exenatide 40 mcg/day, exenatide 60 mcg/day, or placebo. Subjects in the active arms were treated for the first 13 weeks with 3-month devices, which delivered an initial daily dose of 20 mcg, and were then treated with 6-month exenatide at daily doses of 40 mcg or 60 mcg. The study’s primary endpoint was the HbA1c reduction over 39 weeks. Secondary endpoints included changes in weight and the percent of subjects reaching an HbA1c goal of less than 7%.

Both of the exenatide doses were shown to be significantly superior to placebo, and the study met all of its clinical endpoints. In addition, pre-specified subgroup analyses indicated substantial improvement in hyperglycemia across a spectrum of patients and background medications.

Concurrent with the FREEDOM-1 trial, an open-label study — the FREEDOM-1 HBL (high baseline) trial — was conducted in patients who met all of the eligibility criteria for the FREEDOM-1 study, but whose baseline HbA1c was greater than 10% but less than 12%. All of the patients in this study were treated with exenatide 20 mcg/day for the first 3 months and with exenatide 60 mcg/day for the next 6 months. Pre-study oral anti-diabetic agents were maintained unchanged for the 39 weeks of treatment.

The 39-week results showed a sustained reduction of 3.4% in HbA1c among these poorly controlled patients. This study also demonstrated the ability of 39 weeks of treatment with exenatide to bring 25% of these patients, many uncontrolled on multidrug therapy, to their HbA1c goal of less than 7%.

The findings from both of these phase III studies will be submitted for presentation at the American Diabetes Association (ADA) annual meeting, to be held in June 2015 in Boston.

Exenatide is being developed for the treatment of type-2 diabetes. The investigational therapy employs a proprietary technology platform involving a matchstick-size, miniature osmotic pump that is placed under the skin to provide continuous drug therapy, and a proprietary formulation technology, which maintains the stability of therapeutic proteins and peptides at human body temperatures for extended periods. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type-2 diabetes.

If approved, exenatide would be the first injection-free GLP-1 therapy to deliver up to 1 year of treatment in a single subcutaneous mini-pump. Both 6-month and 12-month mini-pumps are in development, and additional phase IIIb studies are planned for next year.

Source: Intarcia Therapeutics; October 2, 2014.

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