Intarcia Announces Presentations of Three Clinical Abstracts at the 47th Annual Meeting of the European Association for the Study of Diabetes
-- Final 48-week results of ITCA 650 phase 2 study involving 155 patients with type 2 diabetes
-- Assessment of ITCA 650 pharmacokinetics and pharmacodynamics among patients treated with ITCA 650 for up to 48 weeks
-- Assessment of treatment-related quality of life among patients treated with ITCA 650
HAYWARD, Calif., Sept. 12, 2011 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the presentation of three clinical abstracts on ITCA 650 (DUROS® subcutaneous continuous delivery of exenatide) for the treatment of type 2 diabetes at the 47th Annual Meeting of the European Association for the Study of Diabetes in Lisbon, Portugal. All three presentations are scheduled for Wednesday, September 14 in the Lisbon International Fair Convention Center.
The first presentation, covering final 48 week results of the ITCA 650 phase 2 study will be delivered by Julio Rosenstock, MD, a principal investigator in the study from the Dallas Diabetes and Endocrine Center in Dallas, TX.
Abstract # 77
Oral Presentation Session OP 13 – GLP-1 receptor agonists
Wednesday, September 14, 2011 from 10:45 -- 12:15 in Roma Hall
Long-term, injection-free treatment with ITCA 650, a continuous subcutaneous delivery of exenatide via DUROS® device, leads to stable glycaemic and weight control for 48 weeks in metformin-treated type 2 diabetes
K. Luskey(1), J. Rosenstock(2), T. Alessi(1), R.R. Henry(3)
(1) Intarcia Therapeutics, Hayward, CA, USA, (2) Dallas Diabetes and Endocrine Center, Dallas, TX, USA, (3) University of California at San Diego, La Jolla, CA, USA.
Two other ITCA 650 presentations will occur in the poster session Wednesday afternoon. Thomas Alessi, PhD, Intarcia's Vice President, Development will present the results of a patient satisfaction study applied to the ITCA 650 phase 2 study and Kenneth Luskey, MD, Intarcia's Chief Medical Officer will present an assessment of the pharmacokinetics and pharmacodynamics observed in the ITCA 650 phase 2 study.
Poster Session PS 063 GLP-1 receptor agonists: new drugs and new formulations
Wednesday, September 14, 2011 from 12:30 -- 1:30 in the Poster Hall
Abstract # 789
Improved patient satisfaction with ITCA 650 vs exenatide injections in subjects with metformin-treated type 2 diabetes
T. Alessi(1), R.R. Henry(2), J. Rosenstock(3), K. Luskey(1)
(1) Intarcia Therapeutics, Hayward, CA, USA, (2) University of California at San Diego, La Jolla, CA, USA, (3) Dallas Diabetes and Endocrine Center, Dallas, TX, USA.
Abstract # 790
Pharmacokinetic and pharmacodynamic assessments with ITCA 650, a continuous subcutaneous delivery of exenatide via DUROS® device, in type 2 diabetes
J. Dahms(1), Y. Chandrasekher(1), R. Fielding(2), R. Zhou(3), R.R. Henry(4), J. Rosenstock(5), T. Alessi(1), K. Luskey(1)
(1) Intarcia Therapeutics, Hayward, CA, USA, (2) Biologistic Services, Boulder, CO, USA, (3) Medpace, Cincinnati, OH, USA, (4) University of California at San Diego, La Jolla, CA, USA, (5) Dallas Diabetes and Endocrine Center, Dallas, TX, USA
About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS continuous subcutaneous delivery of exenatide. The DUROS delivery technology comprises the DUROS device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy. Intarcia's proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.
The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 insertion. Unlike other extended delivery technologies, such as polymers or albumin fusions, DUROS delivery allows for steady state drug delivery upon placement and near immediate cessation of therapy, if required. ITCA 650 is an investigational new drug and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, has been approved in the U.S., Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes. Intarcia's robust IP portfolio protects ITCA 650 through 2027.
About Type 2 Diabetes
According to a June 2011 Lancet publication by Danaei and colleagues, an estimated 347 million adults worldwide had diabetes in 2008 and that number is expected to rise to 472 million by 2030. A significant portion of cases results from striking increases in countries like China and India, accounting for 138 million cases, the USA and Russia, accounting for 36 million cases, and an additional 42 million cases in Brazil, Pakistan, Indonesia, Japan and Mexico. Pre-diabetes, or impaired glucose tolerance (IGT), a condition that often leads to diabetes, affects a population that is roughly double that 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 US alone and projects the cumulative cost of diabetes care to reach $3.4 trillion over the next decade.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to ensure enhanced treatment outcome by optimizing patient adherence and improving the efficacy, convenience and tolerability of drug therapies. 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 its proprietary DUROS drug delivery platform. Intarcia is pursuing a clinical stage development program for type 2 diabetes and has other programs for weight regulation to control obesity.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc. DUROS is a registered trademark of ALZA Corporation licensed to Intarcia Therapeutics, Inc. in certain fields.
SOURCE Intarcia Therapeutics, Inc.