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Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. Changes in HbA1c from baseline were statistically significant across all treatment arms. The most commonly reported adverse events were nausea and vomiting, which were mostly mild, transient, dose dependent and limited to the first week of therapy.
"The results from the phase 1b study demonstrate a pronounced effect on HbA1c and body weight after just 4 weeks of treatment with ITCA 650," said Kenneth L. Luskey, MD, Chief Medical Officer at Intarcia. "ITCA 650 holds the potential to deliver much longer durations of continuous therapy from a single device, and that is currently under clinical investigation."
In addition to its phase 1b clinical data, Intarcia also presented for the first time 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. Purity of exenatide was maintained at levels above 99% for all time points at both room temperature and human body temperature, and bioactivity of exenatide was unchanged throughout the 12-month study duration.
"These studies show that ITCA 650 can deliver 6, 9, or 12 months of exenatide from a single DUROS device," said Thomas Alessi, PhD, Vice President, Development and Manufacturing at Intarcia. "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."
Intarcia is currently conduc
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| SOURCE Intarcia Therapeutics, Inc. Copyright©2009 PR Newswire. All rights reserved |