Intarcia Presents FREEDOM-2 Trial Results in Type 2 Diabetes Demonstrating Clinically Meaningful Superiority and Sustained Glucose Control and Weight Reduction for ITCA 650 vs. Januvia®: Oral Presentation at ADA 76th Scientific Sessions

NEW ORLEANS, June 12, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc. today 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 today in an oral presentation at the 76^th Scientific Sessions of the American Diabetes Association.

"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," said 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. "Key barriers to achieving and sustaining glycemic targets in type 2 diabetes have been related to sub-optimal 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 six months, and eventually up to one year, 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 60mcg 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."

FREEDOM Cardiovascular Outcome Safety Study Topline Results Announced
Intarcia announced last month the successful completion of its fourth and last Phase 3 clinical trial for ITCA 650; the FREEDOM cardiovascular outcome safety study of more than 4,000 patients achieved its primary and secondary endpoints, and the clinical results necessary for regulatory filing. All four Phase 3 clinical trials comprising the FREEDOM Program successfully met their clinical trial endpoints. Filing in the U.S. is expected by the end of 3Q 2016.  

Methodology and Scope of the FREEDOM-2 Clinical Trial
FREEDOM-2 was a multi-center, randomized, active comparator, double-blind, global Phase 3 trial with a 52-week treatment and a 4-week post-treatment follow-up period. The trial enrolled 535 adult patients with HbA1c levels >7.5% and <10.5%.

Patients were on background metformin monotherapy and randomized 1:1 to receive either ITCA 650 60 mcg/day following an introductory dose of ITCA 650 20 mcg/day or once-daily oral Januvia 100 mg/day. The primary endpoint was change in HbA1c between Week 52 and Day 0. Secondary endpoints included the proportion of patients with a decrease in HbA1c of >0.5% and >2 kg weight loss between Week 52 and Day 0, change in body weight between Week 52 and Day 0 and proportion of patients with HbA1c <7% measured at Week 52.

Intarcia presented the full results from its successfully completed FREEDOM-1 and FREEDOM-1 HBL (high baseline) Phase 3 clinical trials last year at the 75th Scientific Sessions of the American Diabetes Association and recently announced topline results from its fourth and final Phase 3 trial, FREEDOM-CVO, which met all of its primary and secondary endpoints.

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 our 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. Intarcia Therapeutics recently completed the ITCA 650 FREEDOM global Phase 3 clinical trial program. Regulatory filing in the U.S. is targeted for end of 3Q, 2016.

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. Delivering medicines for up to a year and beyond 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, peptides, antibody fragments, and other high-potency small molecules at or above body temperature, and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform, the Medici Drug Delivery SystemTM. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic, serious disorders such as diabetes, obesity, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com.

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

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