Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientifi...(from the ITCA 650 phase 1b study have pr...)

Date:6/8/2009

from the ITCA 650 phase 1b study have provided important guidance toward dose selection and study design for continuing clinical development," said Kenneth L. Luskey, MD, VP Clinical Research at Intarcia. "A phase 2 study of ITCA 650 is planned for the third quarter of this year. In this trial we intend to confirm the Phase 1b results on a larger scale and for a longer duration to further characterize the glucose lowering effects and tolerability of ITCA 650."

ITCA 650 therapy in this phase 1b trial was administered for the full course of treatment with a single insertion of the ITCA 650 on day 1 and removal on day 29. The phase 2 trial will evaluate ITCA 650 against the current standard of care for a longer duration of treatment and among a larger population of type 2 diabetes patients. 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 t
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