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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

tolerability and poor compliance trade-offs associated with life-long and frequent self-injections." Graves added, "ITCA 650's 48 week results support our planned phase 3 superiority studies intended to shape a new and compelling value proposition so desperately needed for patients, providers and payors alike."

Study Design and Summary of Week 48 ResultsThe phase 2 study enrolled 155 type 2 diabetes patients (51-53 patients/arm) across 50 centers in the United States. Prior to study entry, patients were on a stable treatment regimen of metformin monotherapy that was continued throughout the study.  The study compared six different regimens of ITCA 650 to optimize dose and regimen for further evaluation in phase 3 studies.

After an initial 12-week treatment period comparing ITCA 650 20 mcg/day and 40 mcg/day with twice-daily injections of exenatide, patients continued treatment with one of 4 doses of ITCA 650: 20, 40, 60 or 80 mcg/day in the following manner through the planned 24-week endpoint:Treatment Weeks 1 – 12Treatment Weeks 13 - 24ITCA 650 20 mcg/day  -->ITCA 650 20 mcg/dayITCA 650 20 mcg/day  -->ITCA 650 60 mcg/dayITCA 650 40 mcg/day  -->ITCA 650 40 mcg/dayITCA 650 40 mcg/day  -->ITCA 650 80 mcg/dayExenatide BID injection  -->ITCA 650 40 mcg/dayExenatide BID injection  -->ITCA 650 60 mcg/dayClinical sites were authorized to offer patients an extension of up to an additional 24 weeks of ITCA 650 treatment to evaluate longer term safety and durability of response.  Among the sites participating in the extension phase, a total of 86 patients (85% of patients at these sites) elected to continue ITCA 650 therapy.

Sustained reductions in HbA1c, FPG and weight were observed across all treatment arms from week 24 through week 48. Reductions in HbA1c were greatest in the 60 mcg/day and 80 mcg/day dose arms but not statistically different between these two do
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SOURCE Intarcia Therapeutics, Inc.
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