Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting

ITCA 650 induces potent reductions of HbA1c and body weight after 4 week treatment; ITCA 650 delivers up to 12 months of exenatide therapy from a single DUROS device

HAYWARD, Calif., Nov. 6 /PRNewswire/ -- Intarcia Therapeutics, Inc. delivered two presentations today on its ITCA 650 (DUROS® continuous delivery of exenatide) program for the treatment of type 2 diabetes at the Ninth Annual Diabetes Technology Meeting in San Francisco, CA:
 

(Logo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO)
 

Continuous Subcutaneous Delivery of Exenatide Via ITCA 650 Lowers Plasma Glucose, HbA1c and Reduces Weight in a 28-day Phase 1b Study in Type 2 Diabetes, K. Luskey, J. McNally, J. Dahms, T. Alessi
 

Stability of ITCA 650 for Continuous Subcutaneous Delivery of Exenatide at Body Temperature for 12 Months, B. Yang, C. Negulescu, R. D'Vaz, C. Eftimie, J. Carr, S. Lautenbach, K. Horwege, R. Mercer, D. Ford, T. Alessi
 

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

"The results from the phase 1b study demonstrate a pronounced effect on HbA1c and body weight after just 4 weeks of treatment with ITCA 650," said Kenneth L. Luskey, MD, Chief Medical Officer at Intarcia. "ITCA 650 holds the potential to deliver much longer durations of continuous therapy from a single device, and that is currently under clinical investigation."
 

In addition to its phase 1b clinical data, Intarcia also presented for the first time results of studies demonstrating the ability of DUROS delivery technology to maintain stability of exenatide at human body temperature and to continuously deliver exenatide for as long as 12 months from a single DUROS device. Purity of exenatide was maintained at levels above 99% for all time points at both room temperature and human body temperature, and bioactivity of exenatide was unchanged throughout the 12-month study duration.
 

"These studies show that ITCA 650 can deliver 6, 9, or 12 months of exenatide from a single DUROS device," said Thomas Alessi, PhD, Vice President, Development and Manufacturing at Intarcia. "DUROS delivery is designed to provide important clinical advantages to patients and physicians by eliminating the need for self-injection, ensuring 100% compliance and improving tolerability and convenience."
 

Intarcia is currently conducting a 3-month phase 2 study comparing ITCA 650 with twice-daily Byetta® exenatide injections 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; provide more consistent, around-the-clock therapeutic drug levels; and 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 one year of therapy from a single ITCA 650 insertion. Unlike other extended delivery technologies, such as polymer encapsulation or albumin fusion, DUROS delivery allows for steady-state drug delivery upon insertion and near immediate withdrawal of therapy, 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 privately held 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.
 

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PRN Photo Desk, photodesk@prnewswire.com

Source: Intarcia Therapeutics, Inc.

CONTACT: James Ahlers, Intarcia Therapeutics, Inc., +1-510-782-7800,
james.ahlers@intarcia.com
 

Web Site: http://www.intarcia.com/
 

Posted: November 2009

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