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Once a Year Byetta in the Diabetes Pipeline
Posted: Wednesday, May 06, 2009
With Lilly/Amylin's submission of their once a week Byetta, another company, Intarcia Therapeutics, Inc., announces completion of enrollment of ITCA 650 phase 1b study for the treatment of Type 2 diabetes with their once a year dosing of Byetta.
Intarcia Therapeutics, Inc., announced last week that the patient accrual to a phase 1b clinical study evaluating ITCA 650 (DUROS ® continuous delivery of exenatide) was completed. The study is being conducted at multiple centers in the United States and involves the treatment of 44 patients with Type 2 diabetes for a period of 4 weeks.
Intarcia began the development of ITCA 650 in 2007 after acquiring an exclusive worldwide license to the DUROS delivery technology. The DUROS delivery technology consists of 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. 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.
Intarcia's phase 1 study is evaluating the safety and pharmacokinetics of ITCA 650 at several doses over a treatment period of 4 weeks. ITCA 650 therapy 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 will support selection of doses to be evaluated in a controlled phase 2 study planned for later in 2009 in which longer durations of treatment with a single ITCA 650 insertion will be evaluated. The DUROS technology can deliver up to a full year of therapy from 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 injection administration. Unlike other extended delivery technologies such as polymers or albumin fusion, DUROS delivery allows for steady state drug delivery upon insertion and near immediate withdrawal of therapy to manage side effects, if required.
ITCA 650 is the second DUROS delivery program Intarcia has moved into clinical development. In December 2008, Intarcia also completed enrollment of a phase 1b study for ITCA 638, which involves DUROS delivery of omega interferon for the treatment of chronic hepatitis C infection.
Source: Diabetes In Control: Intarcia Therapeutics News Release, April 22, 2009
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