Intarcia Announces Presentation of Phase 3 Data at EASD Showing ITCA 650 Markedly Reduces Blood Sugar In Patients With Poorly Controlled Type 2 Diabetes

VIENNA, Sept. 19, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the presentation of positive interim clinical data for its lead candidate ITCA 650 (continuous subcutaneous delivery of exenatide) in type 2 diabetes patients with high baseline HbA1c levels at the 50^th Annual Meeting of the European Association for the Study of Diabetes (EASD). Data from the open-label, phase 3 FREEDOM-HBL (high baseline) trial showed markedly reduced levels of blood sugar in patients with poorly controlled type 2 diabetes. The results were presented by Dr. Robert R. Henry, Chief, VA Endocrinology & Metabolism and Professor of Medicine at UCSD. The overall results from the full 9-month HBL study and the FREEDOM-1 trial are expected to be announced in the fourth quarter of 2014.

In an oral presentation today, Dr. Henry reviewed the 6-month interim data from the FREEDOM-HBL trial, which enrolled T2D patients whose HbA1c levels exceeded the entrance criteria for the FREEDOM-1 phase 3 trial. The presentation, entitled "Efficacy and Tolerability of ITCA 650 (continuous subcutaneous exenatide) in Poorly Controlled Type 2 Diabetes with Baseline A1C >10%," included the following comments, results and conclusions:

• FREEDOM-1 is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of ITCA 650 in type 2 diabetes patients with an HbA1c between 7.5% and 10.0%.
• Patients who met all inclusion criteria for FREEDOM-1 but had HbA1c greater than or equal to 10% but less than or equal to 12% were enrolled in FREEDOM-HBL.
• On average, patients enrolled to FREEDOM-HBL had been diagnosed with T2D for 9 years and a majority was being treated with multiple background oral anti-diabetes therapies.
• Enrolling patients with high baseline HbA1c provides a robust opportunity to evaluate treatment response in a poorly controlled patient population.
• In this interim analysis, the addition of ITCA 650 resulted in mean HbA1c reductions greater than 3% in patients who reached 6 months of treatment.
• 30% of patients who reached 13 weeks of treatment (n=50) achieved the target HbA1c of less than 7%.
• ITCA 650 treatment was also accompanied by weight loss, which is not commonly observed in the treatment of patients with high baseline HbA1c.
• ITCA 650 has the potential to markedly improve glycemic control in patients with severe hyperglycemia and longstanding diabetes.
• ITCA 650 may offer potential benefits over existing oral and injectable therapies for type 2 diabetes via sustained glycemic control, favorable weight profile, improved tolerability, ensured adherence with once- or twice-yearly dosing, and no injections.

"More than 50% of people with type 2 diabetes remain inadequately controlled, often despite one or more treatments," said Dr. Henry. "These interim results may represent a very promising advance toward addressing that unmet need. There are a variety of reasons why there is this large segment of treatment-experienced type 2 diabetes patients who remain poorly controlled, including the progressive nature of the disease, poor adherence to therapy, and lack of aggressive treatment. These results appear to indicate that ITCA 650 can deliver potent effects both in terms of glycemic control and weight loss to a group of patients with very poorly controlled type 2 diabetes and for whom other therapies have failed. While ITCA 650 holds promise for the broad diabetes population, the unique delivery technology has the potential to address the contribution that sub-optimal efficacy and non-adherence play in poor glycemic control. With such promising interim results, I look forward with great anticipation to seeing the full data from the FREEDOM-HBL and FREEDOM-1 studies very soon."

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 proprietary technology platform involving a matchstick-size, miniature osmotic pump that is implanted sub-dermally to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.

Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1C and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily and once weekly self-injection therapy for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM, and the first results from the FREEDOM-1 and FREEDOM-HBL (high baseline) phase 3 studies are expected to be reported in the fourth quarter of this year.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and presents when the body either does not produce enough insulin or becomes resistant to insulin, resulting in high levels of blood sugar. According to a June 2011 Lancet publication by Danaei and colleagues, an estimated 347 million adults worldwide suffered from type 2 diabetes in 2008; that number is expected to rise to 472 million by 2030. It is estimated that pre-diabetes (impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG)) a condition that often leads to diabetes, affects a population roughly twice the size of the current diabetes population. The World Health Organization estimates deaths resulting from diabetes will double between 2005 and 2030 and estimates the global cost of diabetes to have exceeded $400 billion in 2010. United Healthcare expects spending on diabetes and diabetes-related care to reach $500 billion by 2020 in the U.S. alone, and projects the cumulative cost of diabetes care will reach $3.4 trillion over the next decade.

About Intarcia Therapeutics, Inc.

Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, eliminating the need for life-long injections, ensuring compliance and persistency over time with up to once-yearly dosing, and by improving the tolerability of drug therapies. Delivering medicines just once or twice yearly virtually ensures patient compliance and persistency, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platforms. Intarcia is conducting a Phase 3-stage development program for type 2 diabetes and has additional early development programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.

SOURCE Intarcia Therapeutics, Inc.