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Intarcia Presents Compelling 48-week Results for ITCA 650 - Data Underlines the Promise to Become the First Injection-free GLP-1 Therapy at the 47th Annual EASD Meeting in Lisbon
Date:9/14/2011

se arms.

ITCA 650 dose weeks 13-48

20 mcg/day

40 mcg/day

60 mcg/day

80 mcg/dayMean baseline HbA1c (%)

7.8

7.8

8.1

7.9Mean week 48 HbA1c (%)

6.8

6.8

6.6

6.5Mean HbA1c change at week 48 (%)

-1.0

-1.0

-1.5

-1.4Mean weight change at week 48 (lbs)

-6.0

-10.8

-7.7

-7.9Based on the robust treatment response observed at the week-24 study endpoint and the durability of response observed at week 48, a starting dose of ITCA 650 20 mcg/day for weeks 1-12 followed by transition to ITCA 650 60 mcg/day appears to provide the greatest incremental reductions in HbA1c, FPG and body weight with the most favorable tolerability profile.

Throughout the extended treatment duration of the study, there were no treatment discontinuations due to nausea.  Numeric improvements were observed in measures of blood pressure and lipids at weeks 24 and 48 compared to baseline.

"Testing novel therapies over longer treatment durations is very important to confirm sustained effects, safety and tolerability," said Julio Rosenstock, MD, ITCA 650 phase 2 study principal investigator.  "These encouraging findings warrant further investigation of the optimized dose regimen of ITCA 650 20 to 60 mcg/day in larger phase 3 studies and using longer duration devices."  

Patient Satisfaction with ITCA 650 TherapyIn a separate session focusing on new GLP-1 therapies, Thomas R. Alessi, PhD, Intarcia's Vice President, Development, presented the results of a treatment satisfaction survey that was administered to patients before the beginning of the ITCA 650 phase 2 clinical study and at study weeks 8 and 20.  The survey utilized the Diabetes Medication Satisfaction Tool (DM-SAT), a validated and published self-assessment tool.  Study results indicated that patients receiving ITCA 650 at doses of either 20 mcg/day or 40
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SOURCE Intarcia Therapeutics, Inc.
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