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news.Intarcia Therapeutics, a biopharmaceutical company, has completed patient accrual in a Phase Ib clinical study evaluating ITCA 650. The study is being conducted at multiple centers in the US and involves the treatment of 44 patients with type 2 diabetes for a period of four weeks.
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Intarcia’s Phase I study is evaluating the safety and pharmacokinetics of ITCA 650 at several doses over a treatment period of four weeks. ITCA 650 therapy is administered for the full course of therapy with a single insertion of the Duros device on day one and removal on day 29.
Results of the Phase I study will support selection of doses to be evaluated in a controlled Phase II study planned for later in 2009 in which longer durations of treatment with a single ITCA 650 insertion will be evaluated. The Duros technology can deliver up to a full year of therapy from a single ITCA 650 insertion.
Exenatide, the active agent in ITCA 650, has been approved in the US, Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.
The goals of the ITCA 650 program are to enhance the therapeutic effects of exenatide by ensuring patient compliance and providing more consistent, round-the-clock therapeutic drug levels; and to reduce side effects, including nausea, associated with high peak levels of exenatide exposure observed with injection administration.
Alice Leung, president and CEO of Intarcia, said: “We are very pleased with the rapid progress the company has made with ITCA 650. Our team has demonstrated the great potential for Duros delivered therapies in advancing this important treatment candidate for type 2 diabetes patients from an idea to clinical stage development in 18 months.”