ITCA 650

Type 2 diabetes is one of the largest public health threats the U.S. will face over the next decade and existing treatment options fail to address the myriad of challenges patients endure including weight gain, suboptimal blood glucose control, nausea, and poor adherence with treatment. Many patients are burdened with taking several doses of oral medications daily and/or must inject themselves daily. Intarcia recognized the potential for its delivery system to reshape the way diabetes is treated and to offer patients and their health care providers a more convenient long-term treatment regimen. The result is the investigational drug now in late stage clinical development – ITCA 650.

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, osmotic mini-pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily and once weekly self-injection therapy for type 2 diabetes, and a member of a drug class called incretin mimetics.

Intarcia is developing ITCA 650 to provide type 2 diabetes patients with long-term steady state dosing of GLP-1 therapy. Exenatide and other GLP-1s have demonstrated effective glycemic control and weight loss as single agents and in combination with oral antidiabetic drugs. Like other GLP-1s, exenatide is limited by pharmacokinetics that require 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. Due to the inherently short half-life of GLP-1s, extended duration delivery options are an important consideration to facilitate patient compliance and convenience. Our proprietary delivery system has the potential to provide continuous treatment with the flexibility of near immediate reversibility.

ITCA 650 PROGRAM STATUS

Following the completion of successful phase 2 clinical trials, we began studying the efficacy and safety of ITCA 650 in a Phase 3 program called FREEDOM. FREEDOM is a global clinical development program made up of four Phase 3 studies collectively designed to assess whether the addition of ITCA 650 (continuous subcutaneous delivery of exenatide) to current standards of care results in superior outcomes and whether ITCA 650 is superior to the leading branded oral therapy for the treatment of type 2 diabetes. The program is expected to enroll > 5,000 subjects at > 500 clinical investigation sites in > 30 countries to support U.S., EU and other regulatory filings.

The company has now completed four Phase 3 trials in the FREEDOM program. The FREEDOM-1, FREEDOM-1 HBL (High Baseline), FREEDOM-2, and FREEDOM-CVO studies met their primary and secondary endpoints. For top-line results of the studies, please click here. We expect to be able to file for regulatory approvals of ITCA 650 in the first half of 2016.

Pipeline News

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