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Intarcia Presents Positive ITCA 650 Phase 2 Study Results for Type 2 Diabetes at EASD
Date:9/22/2010

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23%week 6

8%

23%

19%week 12

2%

19%

19%Mean improvement in patient-reported QOL
week 8 vs. baseline

21%

34%

13%* p<0.001 relative to baseline"ITCA 650 therapy represents an important advance in the treatment of type 2 diabetes.  For the first time, patients are able to receive all the benefits of a GLP-1 therapy without the need for self-injection," said Robert Henry, M.D., Chief, Section of Diabetes, Endocrinology and Metabolism at the University of California, San Diego. He noted, "Injection has been a significant hurdle for the use of GLP-1 therapies for many patients.  ITCA 650 allows far more patients to benefit from GLP-1 therapy due to better tolerability and ease of administration. We are highly encouraged by improved levels of patient acceptance of ITCA 650, indicating broader use potential."

Summary of Week 24 ResultsAfter initial treatment week 12, patients on the ITCA 650 arms were re-randomized on a 1:1 basis to either continue on the same dose (20 mcg/day or 40 mcg/day) or escalate to higher doses of ITCA 650 (60 mcg/day or 80 mcg/day) for weeks 13 - 24.  Patients on the exenatide injection arm were switched to receive ITCA 650 at a dose of either 40 mcg/day or 60 mcg/day for weeks 13 – 24.

Incremental reductions in HbA1c and weight were observed across all treatment arms at week 24 compared to week 12. Both incremental and aggregate reductions in HbA1c were greatest in the 60 mcg/day and 80 mcg/day dose arms but not measurably different between the two dose arms.  Results of the week 20 quality of life assessment suggest that quality of life improved substantially for patients switching from exenatide injection to ITCA 650 and that the substantial improvement observed among patients initially randomized to ITCA 650 was maintained after transition to higher doses of ITCA 650.ITCA 650 Dose weeks 13 – 24

20 mcg/day


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SOURCE Intarcia Therapeutics, Inc.
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