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SOURCE Intarcia Therapeutics, Inc.
- Highlights will include first interim phase 3 data for ITCA 650, the Company's novel once or twice-yearly GLP-1 receptor agonist for type 2 diabetes. Data will show up to six months of treatment results from Intarcia's global Phase 3 clinical trial program known as FREEDOM -
BOSTON, Jan. 13, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced that Chairman, President and CEO Kurt Graves will present a Company overview today at the J.P. Morgan 32nd Annual Healthcare Conference at 2:00pm Pacific Time at the Westin St. Francis Hotel, in San Francisco, CA.
The presentation will highlight the very active and productive year for the Company with a penetrating look forward into key milestones for 2014 and beyond. A key feature of the session will be Mr. Grave's announcement for the first time of the interim treatment results of the global phase 3 clinical trial program called FREEDOM. If successful, the final results of the complete pivotal studies for ITCA 650 have the potential to demonstrate superiority versus leading medications and the potential to transform treatment outcomes for many patients suffering from type 2 diabetes.
"We are very pleased with the progress we made across the company in 2013, and together with Quintiles and all our investigators we have already enrolled over 1,550 patients in our Global Phase 3 FREEDOM Program. The full global registration program is on track, and two of the four registration trials are already fully enrolled and will produce final results later this year," commented Kurt Graves, Chairman, President and CEO of Intarcia. "Diabetes is a global health crisis of epic proportions, and that is a clear call to action to all of us for new and truly disruptive and innovative approaches that have the potential to dramatically improve outcomes. At Intarcia, we are very excited about that challenge and the opportunity to bring patients, payors and providers a totally novel treatment approach for type 2 diabetes. We look forward to sharing our first interim phase 3 data at J.P. Morgan."
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 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. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM, and first phase 3 pivotal trial results are expected at the end of 3Q, 2014.
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. The Company is co-located in Boston, MA, and Hayward, CA. For more information on the Company, please visit www.intarcia.com.
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