Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions

DUROS(R) continuous delivery of exenatide produces impressive reductions in fasting plasma glucose, HbA1c and body weight during 28-day treatment

NEW ORLEANS, June 8 /PRNewswire/ -- Intarcia Therapeutics, Inc. today presented results from the first clinical 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). Results of the phase 1b 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 substantial reductions in postprandial glucose (PPG), HbA1c and body weight.
 
"This study was designed to evaluate a more effective and patient-friendly approach to deliver exenatide therapy for the treatment of type 2 diabetes," said K. Alice Leung, President & CEO of Intarcia Therapeutics, Inc. "ITCA 650 ensures that patients receive the benefits of an optimized dose of exenatide immediately upon initiation of treatment, and it continuously provides consistent, round-the-clock control of blood glucose without requiring patients to inject themselves."
 
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 44 type 2 diabetes patients (10-12 patients/dose arm) on a stable treatment regimen of diet and exercise or treatment with metformin and/or thiazolidinediones. The study included four dose arms to which patients were randomized to receive 10 mcg/day, 20 mcg/day, 40 mcg/day or 80 mcg/day exenatide for a 28 day treatment duration via a single insertion of ITCA 650.

 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)                 -8.8     -32.3     -47.1     -74.6
 

Substantial decreases in FPG and PPG were observed throughout treatment. Decreases in FPG were evident within 24 hours of the 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.

 

 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             -0.52     -0.62     -0.45     -0.58
 Mean change in weight (kg)       -0.28     -0.31     -0.93     -2.91
 

Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. The most commonly reported adverse events were nausea and vomiting which were mostly mild, transient and dose dependent.

 

 
"The results 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 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.

  MEDIA CONTACT

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

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

Posted: June 2009

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