About the FREEDOM Clinical Trial Program
FREEDOM is a global clinical trial development program made up of four Phase 3 studies of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). The FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were successfully completed and met all primary and secondary endpoints. Results include demonstrating superior efficacy versus placebo and versus market leader, Januvia®. The overall FREEDOM program enrolled more than 5,000 subjects at over 500 clinical investigation sites in more than 30 countries to support U.S., EU and ROW regulatory filings.
About ITCA 650
ITCA 650 is designed 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 receptor agonist therapy.
About Medici Drug Delivery System™
Intarcia's novel technology platform, the Medici Drug Delivery System, is a proprietary subcutaneous delivery system comprised of three unique technologies:
- A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more
- A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication
- A placement technology including proprietary tools designed for a simple, quick and highly reliable user experience
Once trained, physicians, physician's assistants, or nurse practitioners can quickly and simply place the small device in an 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 other end of the device. Each osmotic mini-pump is designed to hold an appropriate volume of drug, to treat a patient for up to a full year and beyond.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines for six-month periods of time, and potentially for up to a year and beyond, may improve outcomes by addressing patient adherence and persistence issues with prescribed drug therapies, which are very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are brought to life within the Medici Drug Delivery System™, the innovative science and technology platform from which Intarcia plans to launch its pipeline of disruptively innovative drugs. Intarcia continues to research and develop treatments utilizing the Medici Drug Delivery System for major chronic disorders such as diabetes, obesity, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
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SOURCE Intarcia Therapeutics, Inc.