Intarcia Therapeutics, Inc. Presents Positive ITCA 650 Phase 2 Study Results as a Late-Breaker at the American Diabetes Association 70th Scientific Sessions

Study evaluates two doses of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) compared with Byetta® (twice daily injections of exenatide)

HAYWARD, Calif., June 28 /PRNewswire/ -- Intarcia Therapeutics, Inc. presented today the results of a phase 2 clinical study of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in Orlando, FL (June 25-29, 2010). Results of the phase 2 study demonstrated substantial reductions in HbA1c and body weight during the 12 weeks of treatment with ITCA 650 at both the 20 mcg/day and 40 mcg/day doses.
 

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The phase 2 study was conducted at 50 centers in the United States and evaluated a 12-week course of two doses of ITCA 650 compared with twice daily injections of exenatide (Byetta®) among 155 type 2 diabetes patients (51-53 patients/arm) on a stable treatment regimen of metformin. The study included three dose arms to which patients were randomized to receive either ITCA 650 at doses of 20 mcg/day or 40 mcg/day, or twice daily injections of exenatide at 5 mcg BID for 4 weeks followed by 10 mcg BID thereafter as indicted in the product label.
 

  Summary of week 12 results



                               ITCA 650 20   ITCA 650 40   Exenatide
                                 mcg/day       mcg/day     injection
  Mean baseline HbA1c                7.90          8.00         8.01
  Mean week 12 HbA1c                 6.94          6.96         7.19
  Change from baseline              -0.96         -1.04        -0.82
  % HbA1c < 7.0                        64%           68%          51%
  --------------------
  % HbA1c < 6.5                        32%           26%          17%
  -------------
  Mean baseline body weight          93.5 kg       91.5 kg      93.4 kg
  Mean % change in body
   weight at week 12                -0.87%        -2.62%       -1.54%
  ---------------------             -----         -----        -----

DUROS continuous delivery of exenatide resulted in a reduced incidence and persistence of treatment-associated nausea. Nausea rates among patients receiving ITCA 650 at 40 mcg/day were similar to those receiving exenatide injections at 10 mcg BID. Nausea rates observed among patients receiving ITCA 650 at 20 mcg/day were lower than patients receiving the same daily dose with BID injections.
 

The phase 2 study also incorporated a quality of life (QOL) assessment (DM-SAT) completed by each patient prior to initiating treatment and again at treatment week 8. The results of this assessment suggest that patients receiving either dose of ITCA 650 experienced greater improvement in their quality of life compared to patients receiving twice daily injections of exenatide.
 

                                     ITCA 650 20  ITCA 650 40  Exenatide
                                       mcg/day      mcg/day    injection
                                         -------      -------   ---------
  % improvement  in patient-assessed
   QOL at week 8                              25%          40%         15%
  ----------------------------------         ---          ---         ---


Other clinical observations from the phase 2 study include reductions in both LDL-C and systolic blood pressure from baseline. Approximately 92% of patients completed treatment, and discontinuation rates ranged from 5.9% on ITCA 650 at 40 mcg/day to 9.4% on exenatide twice daily injection.
 

                           ITCA 650 20 ITCA 650 40  Exenatide
                              mcg/day     mcg/day   injection
  Change in LDL-C           -4.8 mg/dL  -5.4 mg/dL +1.2 mg/dL
  ---------------           ----------  ---------- ----------
  Change in systolic blood
   pressure                 -3.6 mmHg   -6.8 mmHg   -4.2 mmHg
  ------------------------  ---------   ---------   ---------


"The results of the phase 2 study suggest that ITCA 650 may play an important role in the treatment of type 2 diabetes," said Dr. Robert Cuddihy, MD, Medical Director, International Diabetes Center at Park Nicollet in Minneapolis, MN and a study investigator who presented the results at the ADA meeting. "Compliance is a significant challenge for many patients, and ITCA 650 ensures the delivery of every dose everyday. No other treatment can do that."
 

In an ongoing 12-week extension phase of the study, patients receiving ITCA 650 were randomized to remain on their current dose or increase their ITCA 650 dose; patients receiving twice daily injections of exenatide were switched to ITCA 650 therapy at one of two doses. The dosing and treatment changes have been well tolerated and the interim week 20 HbA1c results are presented below.
 

Summary of week 20 interim HbA1c results including 108 patients who have completed 20 weeks of treatment to date:
 

                ITCA 650 20   ITCA 650 40   ITCA 650 60   ITCA 650 80
  Week 20          mcg/day       mcg/day       mcg/day      mcg/day
  Mean baseline
   HbA1c                7.88          7.83          8.06         8.07
  Mean week 20
   HbA1c                7.03          6.77          6.79         6.68
  Change from
   baseline            -0.85         -1.06         -1.27        -1.39
  % HbA1c < 7.0           50%           79%           74%          76%
  -------------          ---           ---           ---          ---
  % HbA1c < 6.5           20%           46%           47%          53%
  -------------          ---           ---           ---          ---


"Our experience in the phase 2 study demonstrates that ITCA 650 is a very well-tolerated treatment option that can be administered in a physician's office by both specialists and primary care physicians," said Kenneth L. Luskey, MD, Intarcia's Chief Medical Officer. "A phase 3 study of ITCA 650 is planned for the fourth quarter of this year. In the trial we intend to confirm the Phase 2 results on a larger scale and for a longer duration to further evaluate the glucose lowering effects and tolerability of ITCA 650."
 

ITCA 650 therapy in the phase 2 trial was administered for the 90-day treatment period with a single insertion of ITCA 650 on day 1 and removal on or around day 90. The extension phase of the 2 trial evaluates higher doses of ITCA 650 using a single device to deliver 3 months of treatment. The phase 3 study planned for later this year will evaluate longer duration ITCA 650 devices.
 

At the time of the presentation, data were available on 108/155 patients who have completed 20 weeks of treatment. All patients are expected to complete the 12-week extension phase of the study in July 2010 and the results of the extension phase will be presented at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden in September 2010.
 

A downloadable version of the ITCA 650 phase 2 presentation from ADA is available on the Intarcia corporate website at http://www.intarcia.com/media_presentations.html
 

About ITCA 650
 

ITCA 650 therapy for type 2 diabetes consists of DUROS continuous subcutaneous 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, 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.
 

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Source: Intarcia Therapeutics, Inc.

CONTACT: James Ahlers, Intarcia Therapeutics, Inc., +1-510-82-7800,
james.ahlers@intarcia.com
 

Web Site: http://www.intarcia.com/
 

Posted: June 2010

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