Home / Resources / Articles / FREEDOM-2 Trial Results for ITCA 650: Breakthrough New Product Announced

FREEDOM-2 Trial Results for ITCA 650: Breakthrough New Product Announced

Jun 25, 2016

In Depth: 76th ADA Scientific Sessions

First a little explanation about the new unique product with its own delivery system. This is not only a medication but also a matchstick-sized osmotic mini pump that is the size of a match and is placed just beneath the skin to deliver a continuous and consistent flow of medication for a year. Imagine no filling of prescriptions every month or taking a shot daily or once a week. This is a constant flow of medication for a year with no refills until after a year, and then you get a new one. They are also working to combine drugs, so that you might be able to do this with your diabetes, heart, blood pressure medicines, etc. Never miss taking your medications again.

In the Freedom-2 trial patients treated with ITCA 650 60 mcg experienced a nearly twofold greater reduction in HbA1c (-1.5% versus -0.8%; p < 0.001), and a threefold greater reduction in weight (-4.0 kg [8.8 lbs] vs. -1.3 kg [2.8 lbs]; p < 0.001) compared to patients treated with Januvia® 100 mg (sitagliptin). Significantly more patients treated with ITCA 650 60 mcg achieved the ADA-recommended HbA1c target of < 7.0% versus Januvia 100 mg (61% vs. 42%; p < 0.001).


Intarcia Therapeutics, Inc. presented positive results from its FREEDOM-2 clinical trial with its late-stage investigational candidate ITCA 650, an injection-free GLP-1 receptor agonist that provides consistent and continuous delivery of exenatide via an osmotic mini-pump that is placed under the skin. ITCA 650 demonstrated superior efficacy to Januvia® in reducing HbA1c and body weight in patients with poorly controlled type 2 diabetes on metformin following one year of treatment. ITCA 650 met all primary and secondary trial endpoints. Significantly greater reductions were seen with ITCA 650 compared to Januvia for both HbA1c and weight early after the initiation of treatment and persisted over the entire 52 weeks. The data was presented on June 12th in an oral presentation at the ADA 76th Scientific Sessions.

Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center at Medical City and a Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas, who was the lead investigator, noted that, “The efficacy demonstrated by ITCA 650 in this trial has significant potential for many type 2 diabetes patients who need better glycemic control and are often non-compliant with their daily or weekly medications. Key barriers to achieving and sustaining glycemic targets in type 2 diabetes have been related to suboptimal efficacy of some medicines, poor adherence and the lack of persistence with therapy over time – whether pills or injections. An innovative treatment like ITCA 650 may soon provide the type 2 diabetes community with a critical new tool that can ensure treatment compliance for periods of 12 months, to help many patients reach and sustain their individual glycemic goals.”

In the study, significantly more patients on ITCA 650 60 mcg versus Januvia 100 mg achieved the ADA-recommended HbA1c target of < 7.0% (61% versus 42%; p < 0.001). An even more dramatic difference occurred in the composite endpoint of HbA1c reductions of greater than or equal to 0.5% and weight reductions of 2 kg (4.4lbs) or greater (61% versus 28%; p < 0.001). Baseline characteristics collected for each participant prior to the trial were similar, with an average age of 55 years, HbA1c level of 8.6%, body mass index (BMI) of 32.6 kg/m2 and duration since type 2 diabetes diagnosis of 8.3 years. In patients treated with ITCA 650, rescue therapy was required in 15% of patients compared to 35% of patients treated with Januvia.

In the FREEDOM-2 trial, ITCA 650 60 mcg also demonstrated a tolerability profile similar to the FREEDOM-1 placebo-controlled trial presented at ADA 2015. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the placement site was less than 1% of all procedures in the trial.

“The impressive results with ITCA 650 in this 52-week, head-to-head trial against Januvia, currently the largest selling oral therapy, demonstrate that ITCA 650 can be an important new treatment option for early use with metformin,” said Kurt Graves, Chairman, President and CEO of Intarcia. “Injectable GLP-1 receptor agonists aren’t typically used early in treatment with metformin because patients and doctors tend to reserve the choice of life-long injections until other options fail. If approved, ITCA 650 given just once or twice-yearly, can provide patients and doctors with a totally new way to deliver GLP-1 therapy much earlier with metformin.”


About ITCA 650

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s innovative technology platform, the Medici Drug Delivery System, a proprietary subcutaneous delivery system comprised of three unique technologies: osmotic mini-pump technology; mini-pump placement technology; and high temperature therapeutic stabilization technology, to provide continuous and consistent drug therapy for up to a full year. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. When approved, ITCA 650 will be the first and only once or twice-yearly, injection-free GLP-1 therapy. Regulatory filing in the U.S. is targeted for end of 3Q, 2016.


Practice Pearls:

  • First subcutaneous delivery system that will last for a year.
  • Might also be available with a combination of drugs.
  • Can make non-compliance a non-issue.


Presented at the 76th ADA Scientific Sessions June 12th, 2016