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Pipeline

Pipeline & Partners

Developing the Medici Drug Delivery System™ to bridge technology and medicine to transform therapeutic categories.

ITCA 650

Intarcia’s most advanced clinical candidate is ITCA 650 (exenatide implant) for the treatment of type 2 diabetes. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily or once weekly self-injection therapy for type 2 diabetes. Due to the inherently short half-life of this category of medicine, extended-duration delivery options to facilitate patient compliance are an important consideration. ITCA 650 is stabilized exenatide delivered through the Medici System™ over extended durations. It has the potential to offer patients a six-month exenatide treatment, while a full-year dose is in development. Because ITCA 650 delivers medication through the Medici System™, it eliminates the need for patients to adhere to daily or weekly injection for GLP-1s. All Phase 3 trials for ITCA 650 have been completed and the New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA).

Next Gen Diabetes, Obesity and HIV

We have made significant strides to grow the pipeline of drug candidates that can be delivered via the Medici System™. Our strategy targets “next gen” diabetes, obesity, autoimmune and HIV through collaborations and partnerships with Numab and the Bill and Melinda Gates Foundation.

Partners and science behind the next generation of medicine delivery across multiple therapeutic categories.

Bill & Melinda Gates Foundation

Intarcia and the Bill & Melinda Gates Foundation are working together to deliver an anti-HIV prophylactic delivered once- or twice-yearly through the Medici Drug Delivery System™ to help prevent the spread of HIV in Sub-Saharan Africa and other regions impacted by the HIV epidemic. This pioneering relationship is just the first step Intarcia is taking in hopes of playing a role in the prevention of chronic disease by leveraging our novel drug delivery technology.

Numab

Intarcia and Numab’s collaboration, announced in March 2015, drives the development of mono-specific and multi-specific antibodies for the treatment of diabetes, obesity, autoimmune and inflammatory diseases. Numab’s discovery and optimization platform offers great potential to identify promising anti-body based therapeutic candidates suitable for the Medici Drug Delivery System™ formulation and delivery technology. In September 2017, the selection of a multi-specific antibody construct targeting autoimmune and inflammatory diseases marked a major milestone in the partnership.


The FREEDOM Global Clinical Trial Development Program and ITCA 650

FREEDOM is a global clinical trial 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 (T2D). The program enrolled >5,000 subjects at >500 clinical investigation sites in >30 countries to support U.S., EU and other regulatory filings. If approved by regulatory authorities, ITCA 650 could transform the way T2D is managed today, as ITCA 650 would be the first and only twice yearly, non-injectable GLP-1 therapy. Our FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were completed.

FREEDOM-1

FREEDOM-1 was a U.S.-only, double-blind study comparing ITCA 650 (20 mcg/d for 13 weeks followed by 40 mcg/d or 60 mcg/d for 26 weeks) to ITCA placebo. This study has been completed and published.

Patients randomized: 460

Inclusion criteria:

  • Ages: 18 to 80 years inclusive
  • Unable to achieve glycemic control with diet & exercise, metformin, sulfonylurea or thiazolidinedione alone or in combination
  • HbA1c levels: 7.5% to 10% inclusive
  • Body mass index: 25 to 45 kg/m2 inclusive

Exclusion criteria:

  • Taken GLP-1 receptor agonist (e.g., exenatide, liraglutide)

  • Taken DPP-4 inhibitors, alpha glucosidase inhibitors, SGLT-2 inhibitors, meglitinides or long-term insulin within last 3 months

 

FREEDOM-1 HBL

FREEDOM-1 HBL (High Baseline) was an open-label study that evaluated ITCA 650 (20 mcg/d for 13 weeks followed by 60 mcg/d for 26 weeks) in patients with HbA1c levels greater than 10%. This study has been completed and published.

Patients enrolled: 60

Inclusion and exclusion criteria:

  • Same as FREEDOM-1 (except baseline HbA1c greater than 10% up to 12%)

 

FREEDOM-2

FREEDOM-2 was a global, active-comparator controlled, double-blind, double-dummy study in patients failing to achieve glycemic control on metformin alone. ITCA 650 (20 mcg/d for 13 weeks followed by 60 mcg/d for 39 weeks) plus oral sitagliptin placebo was compared to sitagliptin (Januvia®, Merck) 100 mg/d plus ITCA placebo. This study has been completed.

Patients randomized: 535

Inclusion criteria:


  • 18 to 80 years inclusive
  • 
Unable to achieve glycemic control while on metformin alone
  • HbA1c: 7.5 to 10.5% inclusive
  • Body mass index: 25 to 45 kg/m2 inclusive

 

FREEDOM-CVO

FREEDOM-CVO was a global, placebo-controlled cardiovascular outcomes study designed to meet the pre-approval safety assessment requirements of the FDA. ITCA 650 (20 mcg/d for 13 weeks followed by 60 mcg/d thereafter) was compared to ITCA placebo in patients on a variety of approved anti-diabetes therapies. This study has been completed.

Patients enrolled: Greater than 4,000 patients
Inclusion criteria:

  • Ages: At least 40 years

  • HbA1c: greater than 6.5%

  • History of coronary, cerebrovascular or peripheral artery disease

 

 

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