Intarcia Announces Two Positive Phase 3 Trials for ITCA 650 in Type 2 Diabetes: FREEDOM-1 and FREEDOM-1 High Baseline (HBL) Study Results

BOSTON, Oct. 1, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced successful top-line results from two of its four phase 3 clinical trials for ITCA 650 (exenatide, delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump). The first trial, FREEDOM-1, was a placebo-controlled, double-blind phase 3 clinical trial that tested the efficacy and safety of ITCA 650 in patients with type 2 diabetes against placebo. This study demonstrated ITCA 650 to be significantly superior to placebo for both 40 mcg and 60 mcg 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 phase 3 clinical trial in type 2 diabetes patients with very high baseline HbA1c levels between 10-12%. 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%. The full findings for both phase 3 trials will be submitted for presentation at the American Diabetes Association (ADA) annual meeting in June of 2015 in Boston. 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.

"I am extremely pleased with these phase 3 results. They delivered everything one could have hoped regarding ITCA 650's ability to provide sustained blood sugar control for many type 2 diabetes patients who are not achieving their goals – and all of this without the need for regular self-injections," said Robert Henry, M.D., Chief, VA Endocrinology & Metabolism, and Professor of Medicine in Residence at UCSD. "I think these new data indicate clearly that the ITCA 650 method of delivery provides an uninterrupted, smooth and continuous dose that assures adherence without the need for patient action or behavior modification, which we all know is extremely challenging for many patients. With continued success in the remaining phase 3 trials, we should have a real game-changing therapy available soon to help physicians to better manage this serious disease. We desperately need new innovations like ITCA 650 that have the potential to positively affect the treatment of this devastating and growing epidemic worldwide."

"Our first phase 3 results are truly remarkable and they mark a major milestone for our company and for our mission to bring potential game-changing and life-enhancing therapies to patients, payors, and providers," said Kurt Graves, Chairman, President and Chief Executive Officer of Intarcia. "We will continue our aim to be disruptively innovative in diabetes and metabolism while also building a focused pipeline in other chronic and serious diseases where we believe we can win for patients. We now have evidence that we have a totally new and transformational way of delivering important medicines. Many thought an emerging biotech company could never innovate enough, finance enough, or execute well enough to bring a transformational therapy through phase 3 in a major disease area like type 2 diabetes. But we've proven it can be done, and done well. This landmark event for Intarcia was made possible by our vision and our pioneering people, our world-class investors, our key partners like Quintiles, and the 5,000 people who are volunteering for our clinical studies, and the doctors, nurses/PAs and clinical trial coordinators who've managed those studies. I offer my heartfelt thanks to each and every one of them. We now look forward to finishing the rest of our trials and working closely with global health authorities as we strive to prepare ITCA 650 for filing and registration, and then to make it available to patients and the broader healthcare system."

Methodology and Scope of the FREEDOM-1 Clinical Trial
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 in many cases, were taking up two or three oral anti-diabetes drugs. Subjects enrolled in the trial had HbA1c measures between 7.5% and 10.0%. 460 patients were randomized into three groups in a 1:1:1 ratio, evaluating ITCA 650 40 mcg/d and 60 mcg/d versus placebo. Subjects in the active arms were treated for the first 13 weeks with 3-month devices that delivered 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 was HbA1c reduction over 39 weeks. Secondary endpoints included changes in weight, and the percent of subjects reaching an HbA1c goal of <7%.

Methodology and Scope of the FREEDOM-1 HBL Clinical Trial
Concurrent with FREEDOM-1, Intarcia also conducted an open-label study called FREEDOM-1 HBL (high baseline), for patients who met all eligibility criteria for FREEDOM-1, but whose baseline HbA1c was greater than 10% but less than 12%. All patients in this study were treated with ITCA 650 20 mcg/d for the first 3 months and with ITCA 650 60 mcg/d for the next 6 months. Pre-study oral anti-diabetic agents (OADs) were maintained unchanged for the 39 weeks of treatment.

About ITCA 650
ITCA 650 (a once or twice-yearly 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 placed 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 extended periods of time. 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. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM.

About the Overall FREEDOM Phase 3 Clinical Trial Program
Intarcia's FREEDOM clinical 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 5,000 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. This study has been completed.
• FREEDOM-1 HBL (High Baseline) is an open-label study for patients meeting all the entrance criteria for FREEDOM-1, but with HbA1c levels greater than 10%. This study has been completed.
• FREEDOM-2 is 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). This study is ongoing and on track for completion in summer of 2015.
• FREEDOM-CVO Safety Study is a global, placebo-controlled cardiovascular outcomes study examining the safety of ITCA 650 at 60 mcg/d vs. placebo in approximately 4,000 patients on a variety of approved anti-diabetes therapies. This study is ongoing and on track.

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 has the potential to ensure improved 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 conducting a phase 3-stage development program for type 2 diabetes that consists of four separate clinical trials, two of which have been completed. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic serious disorders in the field of diabetes and 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.