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Intarcia Therapeutics, Inc. Presents Positive Results of ITCA 650 Phase 1b Study in Type 2 Diabetes at the European Association for the Study of Diabetes Conference
Date:9/30/2009

VIENNA, Sept. 30 /PRNewswire/ -- Intarcia Therapeutics, Inc. today presented final results from its Phase 1b clinical study of ITCA 650 (DUROS® continuous delivery of exenatide) for the treatment of type 2 diabetes at the Annual Conference of the European Association for the Study of Diabetes in Vienna, Austria. Results of the study demonstrate substantial reductions in fasting plasma glucose (FPG) within 24 hours of the start of treatment and a sustained glucose lowering effect throughout the 28 day treatment period. Other important results from the study were significant reductions in postprandial glucose (PPG), HbA1c and body weight.

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"The results from the ITCA 650 phase 1b study demonstrate the potential for DUROS continuous delivery of exenatide to improve the treatment of type 2 diabetes," said Kenneth L. Luskey, MD, VP Clinical Research at Intarcia. "ITCA 650 addresses some of the key limitations observed with other incretin mimetic therapies by eliminating the need for frequent self-injection, limiting the incidence and persistence of nausea and ensuring treatment compliance."

The phase 1b dose ranging study was conducted at multiple centers in the United States and evaluated a 28-day course of ITCA 650 treatment among patients with type 2 diabetes (10-12 patients/dose arm) on a stable treatment regimen of diet and exercise or treatment with metformin and/or thiazolidinediones. The study included 4 dose arms to which patients were randomized to receive 10 mcg/day, 20mcg/day, 40 mcg/day or 80 mcg/day exenatide for a 28 day treatment duration via a single insertion 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.

    Fasting & Postprandial Glucose  ITCA 650 Dose Arms (continuous daily dose)
                                    ------------------------------------------
                                     10          20          40         80
                                   mcg/day     mcg/day     mcg/day    mcg/day
    --------------------------------------------------------------------------
    Mean FPG at baseline (mg/dL)     161.2       170.5       171.8      145.1
    --------------------------------------------------------------------------
    Mean FPG at end of
     treatment (mg/dL)               155.6       139.4       129.8      116.3
    --------------------------------------------------------------------------
    Change from baseline (mg/dL)      -5.6       -31.1*      -42.0*     -28.8*
    --------------------------------------------------------------------------
    Change in 2-hr PPG at end
     of treatment (mg/dL)            -16.3       -34.7*      -47.1*     -69.6*
    --------------------------------------------------------------------------
    *p = < 0.05

Substantial decreases in FPG and PPG were observed throughout treatment. Decreases in FPG were evident within 24 hours after initiation of treatment, suggesting a rapid and consistent achievement of desired exenatide levels with DUROS delivery. Changes in PPG measured at days 15 and 29 also showed consistent dose-dependent reductions. Changes from baseline in FPG and PPG were statistically significant for the 20 mcg/day, 40 mcg/day and 80 mcg/day doses.

    HbA1c & Body Weight             ITCA 650 Dose Arms (continuous daily dose)
                                    ------------------------------------------
                                     10          20          40        80
                                   mcg/day     mcg/day     mcg/day   mcg/day
    --------------------------------------------------------------------------
    % HbA1c at baseline               7.67        7.90        7.45       7.38
    --------------------------------------------------------------------------
    % HbA1c at end of treatment       7.15        7.28        7.00       6.80
    --------------------------------------------------------------------------
    Change from baseline             -0.54*      -0.62*      -0.45*     -0.73*
    --------------------------------------------------------------------------
    Mean change in weight (kg)       -0.27       -0.28       -1.13      -3.09*
    --------------------------------------------------------------------------
    *p = < 0.05

Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. Changes in HbA1c from baseline were statistically significant across all treatment arms. The most commonly reported adverse events were nausea and vomiting which were mostly mild, transient, dose dependent and limited to the first week of therapy.

"We've been very pleased with the positive results of this study and rapid progress in the ITCA 650 development program," said K. Alice Leung, President and CEO of Intarcia. "Within just 4 months of completing the phase 1b study, Intarcia began enrollment of an ongoing phase 2 study comparing ITCA 650 with twice-daily Byetta® (exenatide) injection among 150 patients with type 2 diabetes over a 3-month treatment period."

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, around-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 patented 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. Byetta is a registered trademark of Amylin Pharmaceuticals, Inc.

    MEDIA CONTACT
    Intarcia:
    James Ahlers
    Intarcia Therapeutics, Inc.
    (510)782-7800
    james.ahlers@intarcia.com

SOURCE Intarcia Therapeutics, Inc.


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SOURCE Intarcia Therapeutics, Inc.
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