ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed as a once- or twice-yearly therapy for the chronic treatment of type 2 diabetes. The investigational therapy employs Intarcia’s innovative technology platform, the Medici Drug Delivery System™. In its Phase 3 clinical trials for type 2 diabetes, ITCA 650 was evaluated while delivering a continuous and consistent drug therapy in a three-month initiation dose, followed by consecutive six-month doses. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. If approved, ITCA 650 would be the first and only injection-free GLP-1 therapy. Intarcia Therapeutics successfully completed its FREEDOM global Phase 3 clinical trial program for ITCA 650, with each of the four studies meeting their clinical endpoints.
Intarcia’s novel medical delivery technology platform, the Medici Drug Delivery System, is a proprietary subcutaneous delivery system comprised of three unique technologies:
Once trained, physicians, physician’s assistants, or nurse practitioners can quickly and simply place the small device in a comfortable in-office procedure. Once in place under the skin, water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into a salt osmotic engine – that expands to drive a piston at a controlled rate. This allows the drug within the pump to be released in a steady, consistent fashion at the distal end of the device. Each osmotic mini-pump is designed to hold an appropriate volume of either mono or combination therapy, to treat a patient for up to a full year and beyond. — Intarcia Press Release