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news.It delivers up to 12 months of exenatide therapy from a single DUROS device
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Intarcia has presented data for ITCA 650 (DUROS continuous delivery of exenatide) program for the treatment of type 2 diabetes at the Ninth Annual Diabetes Technology Meeting in San Francisco, CA.
Intarcia’s ITCA 650 phase 1b clinical study was conducted at multiple centers in the US and evaluated a 28-day course of ITCA 650 treatment in patients with type 2 diabetes on a stable treatment regimen of diet and exercise or treatment with metformin and/or thiazolidinediones. The study included 4 dose arms (10-12 patients/dose arm) to which patients were randomised to receive 10mcg/day, 20mcg/day, 40mcg/day or 80mcg/day of exenatide for a 28-day treatment duration. ITCA 650 therapy was administered for the full course of treatment with a single insertion of the ITCA 650 on day 1 and removal on day 29.
Substantial decreases in FPG and PPG were observed throughout treatment. Decreases in FPG were evident within 24 hours after initiation of treatment with DUROS delivery. Changes in PPG measured at days 15 and 29 also showed consistent dose-dependent reductions. Changes from baseline in FPG and PPG were statistically significant for the 20mcg/day, 40mcg/day and 80mcg/day doses.
Thomas Alessi, vice president of development and manufacturing at Intarcia, said: “These studies show that ITCA 650 can deliver 6, 9, or 12 months of exenatide from a single DUROS device. DUROS delivery is designed to provide important clinical advantages to patients and physicians by eliminating the need for self-injection, ensuring 100% compliance and improving tolerability and convenience.”
In addition to its phase 1b clinical data, Intarcia also presented results of studies demonstrating the ability of DUROS delivery technology to maintain stability of exenatide at human body temperature and to continuously deliver exenatide for as long as 12 months from a single DUROS device.
Intarcia is currently conducting a 3-month phase 2 study comparing ITCA 650 with twice-daily Byetta exenatide injections among a larger population of type 2 diabetes patients.