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Among the many classes of effective treatments for type 2 diabetes, a new class called incretin mimetics represents some very important advantages. Incretin mimetics have the effect of lowering blood glucose and decreasing weight through multiple biological activities. The development of incretin mimetics offering these beneficial effects has been an important focus of research in the fields of type 2 diabetes and obesity. The first incretin mimetic was approved by the US FDA in 2005 and others are currently in clinical and preclinical development. ITCA 650 (DUROS delivery of exenatide for type 2 diabetes) Intarcia’s clinical stage type 2 diabetes candidate known as ITCA 650 involves the delivery of exenatide, an approved incretin mimetic, with the subcutaneous DUROS delivery device. Intarcia is developing ITCA 650 to provide type 2 diabetes patients with long-term steady state dosing of a incretin mimetic therapy. Exenatide and other incretin mimetics have demonstrated effective glycemic control and weight loss, as single agents and in combination with oral antidiabetic drugs. Like other incretin mimetics, exenatide is limited by pharmacokinetics that require twice-daily self injection and cause side effects such as nausea that often lead to poor compliance or premature discontinuation of treatment. ITCA 650 is designed to deliver a continuous and constant dose of exenatide over an extended period of time, thereby providing round-the-clock therapeutic benefits to the patient but minimizing peak drug level related side effects such as nausea. Due to the inherently short half-life of incretin mimetics, extended duration delivery options are an important consideration to facilitate patient compliance and convenience. However, some extended delivery options have compromised a healthcare provider’s ability to quickly withdraw therapy should an unscheduled cessation of treatment be required. DUROS delivery provides the longest duration of continuous treatment with the flexibility of near immediate reversibility. ITCA 650 Program Status 
Intarcia has developed ITCA 650 formulations that provide excellent stability of exenatide at human body temperature and consistent delivery from the DUROS device for 3, 6 or 12 months. An IND for ITCA 650 was filed with the US FDA in December 2008 and Intarcia initiated its first clinical trial of ITCA 650 in patients with type 2 diabetes in the first quarter of 2009. The ITCA 650 Phase 1b study is evaluating 4 different doses of exenatide over a treatment duration of 28-days delivered with a single insertion of a DUROS device. The goals of the ITCA 650 phase 1b study are to assess safety and establish an appropriate dose or doses for evaluation in a phase 2 study planned for the second half of 2009. The results of the ITCA 650 phase 1b study will be submitted for presentation at scientific conferences in 2009.
Type 2 diabetes is the most common form of diabetes, accounting for more than 90% of all cases, affecting approximately 246 million adults worldwide and more than 23.6 million in the US alone. According to the American Diabetes Association, 1.6 million new cases of diabetes were diagnosed in people aged 20 years or older in the US in 2007. The treatment for type 2 diabetes can be divided into insulin and non-insulin segments. Patients can manage their type 2 diabetes for a time with careful adherence to a prescribed diet along with regular exercise. When diet and exercise alone can no longer provide adequate control of glucose levels, patients are usually treated with one or more oral antidiabetic drugs. Ultimately however, even combinations of these drugs fail to adequately control type 2 diabetes for most patients, at which point an insulin-based treatment regimen is prescribed. The Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes recommends use of incretin mimetic therapy in combination with or to replace oral therapies in order to improve glycemic control or to avoid side effects common to other therapies.
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