Intarcia Therapeutics, Inc. 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 Therapeutics, Inc. 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%
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
Christian Frois, Ph.D., of Analysis Group, Inc. will present the first data in a series of planned retrospective studies sponsored by Intarcia to characterise the prevalence of poor control of HbA1c in type 2 diabetes, and the contributory role of non-adherence and serial non-adherence, more accurately characterising 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.
