Intarcia Enrolls First Patients in "FREEDOM" Global Phase 3 Program for ITCA 650 in Type 2 Diabetes

BOSTON, March 21, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the enrollment of the first patients in FREEDOM-1, the first of four planned Phase 3 clinical trials studying the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). Intarcia is conducting the FREEDOM clinical program with strategic partner Quintiles, Inc., the world's leading clinical research organization, who will be responsible for the global implementation of all four trials. This collaboration, along with strategic input from a world-class group of renowned diabetes experts, is designed to achieve the highest standards of quality, safety and operational excellence.

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The FREEDOM clinical trial program aims to demonstrate that optimizing GLP-1 therapy with once- or twice-yearly dosing of ITCA 650 results in effective, well tolerated glycemic control that virtually ensures longer-term compliance – a transformational approach to controlling T2D that aims to free patients from the frequent self-injections that all too often result in poor therapeutic compliance and control. The FREEDOM-1 study is a placebo-controlled, double-blind study involving T2D patients whose HbA1c is not controlled on zero to three oral anti-diabetes drugs and whose HbA1c measures between 7.5% and 10.0%. The 450 patients will be randomized into three groups in a 1:1:1 ratio, evaluating ITCA 650 40 mcg/d and ITCA 650 60 mcg/d versus placebo. Subjects in the active arms will be treated with 3-month devices for the first 13 weeks that deliver an initial dose of 20 mcg/d, and then treated with 6-month ITCA 650 at doses of 40 or 60 mcg/d. The primary endpoint will be change in HbA1c at 9 months; secondary endpoints include changes in weight, FPG, PPG, tolerability, and other measures of safety and efficacy.

Michelle Baron, MD, FACE, Vice President and Chief Medical Officer of Intarcia, commented on the initiation of the FREEDOM Phase 3 program: "We named our program 'FREEDOM' in recognition of the burden that patients with type 2 diabetes face every day of their lives, and our sincere hope that ITCA 650 will alleviate some of that burden by achieving glucose control in a manner that optimizes patient adherence to therapy. It is well documented that sub-optimal adherence to medication results in poor outcomes and disproportionately higher medical costs. Our goal is to demonstrate that ITCA 650 can successfully deliver up to a full year of treatment from a single placement of the mini-pump – a potential breakthrough in addressing a huge unmet need in this chronic disease. We expect these studies to support regulatory submissions in both the U.S. and the EU, and anticipate the first clinical results in the second half of 2014."

"Our vision is to unleash a game-changing type 2 diabetes treatment that is so innovative and disruptive that it could truly reshape the standard of care and enable far better outcomes for the many patients suffering from this devastating disease," said Kurt Graves, Chairman, President and CEO of Intarcia. "Years of innovation and tenacity have paved the way for the first potential once-yearly type 2 diabetes medicine and the start of the FREEDOM program. We firmly believe that a once-yearly GLP-1 therapy that virtually ensures long-term compliance can do extremely well in any real-world outcomes comparative trials and in the payor-driven and outcomes-focused healthcare environment of the future. As a Company committed to delivering superior outcomes for patients, physicians, and payors, the enrollment of the first patient in our FREEDOM clinical series is very exciting and gratifying milestone for us."

Concurrent with FREEDOM-1, Intarcia will also be conducting an open-label study, called FREEDOM-1 HBL (high baseline), in patients who meet all eligibility criteria for FREEDOM-1, but whose baseline HbA1c is greater than 10%. All patients in this study will be treated with ITCA 650 20 mcg/d for the first 3 months and with ITCA 650 60 mcg/d for the next 6 months.

About the FREEDOM Program

The FREEDOM program is designed to evaluate the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes. Intarcia expects to enroll greater than 4,000 patients at more than 500 clinical trial sites in more than 30 countries. The clinical studies will cover a broad range of patients whose diabetes is not controlled by oral anti-diabetes medications including metformin and metformin-based combinations. FREEDOM-1 is a U.S.-only, placebo-controlled, double-blind study comparing ITCA 650 doses of 40 mcg/d and 60 mcg/d to placebo; the FREEDOM-2 study will be a 500-patient, global, active-comparator controlled, double-blind, double-dummy study in patients on metformin only, comparing ITCA 650 20 mcg/d for 13 weeks plus ITCA 650 60 mcg/d for 39 weeks to patients taking sitagliptin (Januvia®, Merck); FREEDOM-CVO is a global, placebo-controlled cardiovascular outcomes study that will examine the safety of ITCA 650 at 60 mcg/d vs. placebo in approximately 3,000 patients on a variety of approved anti-diabetes therapies.

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 inserted subcutaneously 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 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 twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031.

About Type 2 Diabetes

Every day, 5,225 new cases of diabetes are diagnosed in the U.S. alone, 90% to 95% of which are designated type 2 (T2D). T2D presents when the body either does not produce enough insulin or becomes resistant to insulin, resulting in high levels of blood sugar. The International Diabetes Federation estimates that 366 million adults worldwide suffered from T2D in 2011 and predicts this number will rise to 552 million by 2030; the Centers for Disease Control predicts that 25% to 33% of the U.S. adult population will have diabetes by 2050. It is estimated that pre-diabetes, or impaired glucose tolerance (IGT), 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, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly virtually ensures patient adherence and compliance, 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 platform. Intarcia is pursuing a Phase 3-stage development program for type 2 diabetes and has additional 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.

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