Intarcia Announces Two Presentations At 50th EASD Meeting: Confirms Pivotal Phase 3 Data Announcement For ITCA 650 In Type 2 Diabetes In 4Q
- Oral presentation 9/19: interim Phase 3 results for ITCA 650 among patients with high baseline (HBL) HbA1c levels between 10-12% showed dramatic HbA1c reductions, even in patients with high HbA1c despite multi-drug therapy
- Poster presentation 9/17: highlights overall problem of poor control of HbA1c in type 2 diabetes, and clarifies the clinical/economic burdens of "serial non-adherence" and its predictive role in clinical management
- Intarcia's global ITCA 650 phase 3 program remains on track; confirms plans to announce final top-line results from two phase 3 trials in 4Q 2014
BOSTON, Sept. 11, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced its participation in the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), taking place in Vienna September 15 -19. Intarcia's lead product candidate, ITCA 650, (exenatide, delivered continuously through a matchstick-size, subcutaneous osmotic pump) is currently in multiple global Phase 3 trials and could become the first once-yearly, injection-free GLP-1 therapy for the treatment of type 2 diabetes. Intarcia's global ITCA 650 phase 3 program (FREEDOM program in over 4,000 patients) remains on track; Company confirms plans to announce final top-line results from two phase 3 trials in 4Q 2014.
"Efficacy and Tolerability of ITCA 650 (continuous subcutaneous exenatide) in Poorly Controlled Type 2 Diabetes with Baseline A1C >10%." SEPTEMBER 19th
On Friday, September 19 at 11:45 am CEST, Robert Henry, M.D., Chief, VA Endocrinology & Metabolism and Professor of Medicine in Residence at UCSD, will give a live oral presentation of data from Intarcia's FREEDOM-HBL (High Baseline) trial. The data are interim 6-month results from an open-label Phase 3 clinical trial of ITCA 650 in patients with type 2 diabetes whose HbA1c baseline levels were quite high between 10-12%.
"The Burden of 'Serial Non-adherence' in Type 2 Diabetic Patients." SEPTEMBER 17th
On Wednesday, September 17th at 2:15 pm CEST, Christian Frois, Ph.D., of Analysis Group, Inc. will present the first data in a series of planned retrospective studies sponsored by Intarcia to characterize the prevalence of poor control of HbA1c in type 2 diabetes, and the contributory role of non-adherence and serial non-adherence, more accurately characterizing the economic burden associated with non-adherence with anti-diabetic therapy – including hypoglycemia-related healthcare costs. The study also identifies key predictors of non-adherence to anti-diabetic therapy, predictors that could enable clinicians to take preemptive action to improve outcomes. The presentation #1054 will be delivered in the Poster Session 088, Lifestyle and Delivery of Care.
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 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 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.
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.
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