First clinical study evaluating DUROS(R) continuous delivery of exenatide for the treatment of type 2 diabetes
HAYWARD, Calif., May 27 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced it will present clinical data from a phase 1b study of ITCA 650 (DUROS(R) continuous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in New Orleans, LA (June 5-9, 2009). The study was conducted at multiple centers in the United States and evaluated a 4-week course of ITCA 650 treatment among 44 patients (n= 10-12 patients/dose arm) with type 2 diabetes.
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ITCA 650 Late-Breaker Abstract 4-LB in Category 01-C Clinical Therapeutics/ New Technology - Other Drug Delivery Systems:
A Phase 1b Study of ITCA 650: Continuous Subcutaneous Delivery of Exenatide via DUROS(R) Device Lowers Fasting and Postprandial Plasma Glucose - Luskey, K., McNally, J., Dahms, J., Logan, D., Weiner, G., Denham, D. and Alessi, T.
“We are very pleased the ADA scientific reviewers selected our study for presentation as a late-breaker,” said Alice Leung, President & CEO of Intarcia Therapeutics, Inc. “Our team worked very hard to advance this program from an idea to clinical evaluation in under 18 months. In continuing this brisk pace, we expect to begin a phase 2 study of ITCA 650 in the second half of this year.”
The late-breaker abstract describes the dose-ranging design of the study and preliminary results from the two lower doses of 10mcg/day and 20 mcg/day through the first two weeks of treatment. Based on the favorable tolerability of DUROS continuous delivery of exenatide on the lower doses, patients have been enrolled to two higher dose arms of 40mcg/day and 80mcg/day, and 4-week results from all four cohorts will be presented in the late breaker session at the American Diabetes Association Conference. Dr. Kenneth Luskey, VP, Clinical Research, at Intarcia will be available to answer questions on Saturday, June 6, from 6:15 pm until 7:30 pm, during the Poster Reception, and on Monday, June 8, from 12:00 noon until 2:00 pm, during the Poster Presentation Session in Hall E of the Morial Convention Center in New Orleans.
“We are very encouraged by the preliminary results of this first clinical study of ITCA 650,” said Dr. Luskey. “We look forward to presenting a more complete analysis of 28-day results from all four dose arms at the ADA Conference.”
ITCA 650 therapy in this phase 1 trial is administered for the full course of therapy with a single insertion of the DUROS device on day 1 and removal on day 29. Results of the phase 1 study have supported the selection of doses to be evaluated in a controlled phase 2 study planned to begin later this year. This phase 2 trial will evaluate ITCA 650 against current standard of care, with longer durations of treatment using a single ITCA 650 insertion. The goals of the ITCA 650 program are to enhance the therapeutic effects of exenatide by ensuring patient compliance and providing more consistent, round-the-clock therapeutic drug levels; and to reduce side effects, including nausea associated with high peak levels of exenatide exposure observed with repeated injections.
About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS continuous 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, and proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature 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 insertion and near immediate withdrawal of therapy to manage side effects, if required. Exenatide, the active agent in ITCA 650, has been approved in the US, Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.
About Intarcia
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to ensure enhanced treatment outcome by optimizing patient adherence and improving the 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 the proprietary DUROS drug delivery platform. Intarcia is pursuing clinical stage development programs for type 2 diabetes and hepatitis C.
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.
CONTACT: James Ahlers of Intarcia Therapeutics, Inc., +1-510-782-7800,
james.ahlers@intarcia.com
Web site: http://www.intarcia.com/
