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Intarcia Announces Presentation of Analysis Used for Dose Selection for Global ITCA 650 Phase 3 Program for Type 2 Diabetes at EASD

Intarcia Announces Presentation of Analysis Used for Dose Selection for Global ITCA 650 Phase 3 Program for Type 2 Diabetes at EASD

  • Continuous long-term delivery of exenatide with Intarcia's osmotic mini-pump system allows optimal dose selection for improved glycemic control ensures adherence and improved patient tolerability
  • ITCA 650 global Phase 3 program commencing in Q1 2013

HAYWARD, CALIFORNIA – October 3, 2012Intarcia Therapeutics, Inc. announced the presentation of an analysis of phase 2 clinical study results for ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at Germany on Wednesday, October 3, by Dr. Robert R. Henry, MD, Chief, Section of the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin Diabetes, Endocrinology and Metabolism at the University of California, San Diego. The analysis was performed to facilitate selection of the optimal dosing regimen to be evaluated in the ITCA 650 global Phase 3 clinical program beginning in January 2013.

"Published data with GLP-1 receptor agonist therapy demonstrate the profound importance of selecting the right dose. This can be complicated when administering a GLP-1 with injections due to variability in drug levels and poor patient adherence to prescribed regimens of regular self-injection,” said Robert R. Henry, MD. “ITCA 650's unique ability to consistently deliver a very precise dose of exenatide for up to a full year with just one mini-pump represents a very significant advance in the treatment of type 2 diabetes."

The ITCA 650 phase 2 study enrolled 155 patients whose type 2 diabetes was inadequately controlled with metformin therapy alone. The trial was conducted in two stages:

Selecting an Optimal ITCA 650 Starting Dose

Stage I, weeks 1 - 12, compared two doses of ITCA 650, 20 mcg/day vs. 40 mcg/day, to determine the best starting dose to be administered during the first three months of treatment. In addition, a control arm in which patients were administered exenatide BID injections according to the product labeling was included as a benchmark for both efficacy and tolerability. Both ITCA 650 doses produced a robust 1.0% mean reduction in HbA1c at week 12 compared to a 0.7% reduction in HbA1c in patients receiving exenatide BID injection. The results for exenatide BID injection were consistent with previously published results in patients on metformin monotherapy. The assessment of patient tolerability over the 12-week initial treatment period revealed a lower incidence of nausea over time and a shorter duration of nausea with the 20 mcg/day dose of ITCA 650 compared with exenatide BID injections. By week 12, only 2% of patients receiving the 20 mcg/day dose of ITCA 650 reported any nausea, while approximately 20% of patients receiving either exenatide BID injection or the 40 mcg/day dose of ITCA 650 reported nausea. Finally, in self-assessments of treatment satisfaction, patients receiving ITCA 650 (20 mcg/day or 40 mcg/day) reported greater improvement in overall quality of life scores than did patients on exenatide BID injections. Based on the results of this multi-factorial assessment, an ITCA 650 dose of 20 mcg/day was selected for further evaluation in Phase 3 studies as the best tolerated starting dose that also provided robust HbA1c reductions and enhanced patient-reported quality of life.

Selecting an Optimal Maintenance Dose of ITCA 650

Stage II, weeks 13 - 24, assessed the changes in HbA1c and weight at week 24. Study patients were re-randomized to either remain on their original assigned starting dose of ITCA 650, or to escalate to a higher dose of ITCA 650. Patients who received exenatide BID injections in Stage I were switched to ITCA 650. At week 24, patients whose ITCA 650 dose was increased to 60 or 80 mcg/day achieved greater reductions in HbA1c than did patients who remained on 20 or 40 mcg/day doses of ITCA 650.

    ITCA 650 Stage II Dose/day

    20mcg 40mcg 60mcg 80mcg
Mean baseline HbA1c (%)   8.0 7.9 8.0 8.1
Mean week 24 HbA1c Reduction (%)   -0.9 -1.0 -1.3 -1.4

An additional analysis of week 24 response by baseline HbA1c revealed that patients receiving 60 mcg/day of ITCA 650 who had higher baseline HbA1c achieved greater reductions in HbA1c and were more likely to achieve target HbA1c goals of <=7.0% and <=6.5% compared with patients receiving lower doses of ITCA 650. Forty-four percent of patients with baseline HbA1c >8.0% achieved the target HbA1c goal of <=6.5% by week 24.

      ITCA 650 Stage II 60 mcg/day

 
Mean week 24 HbA1c in all patients     -1.3  
Mean week 24 HbA1c in all patients with Baseline > 7.5%     -1.7  
Mean week 24 HbA1c in all patients with Baseline > 8.0%     -2.1  

Daily doses of 40, 60 and 80 mcg/day resulted in similar reductions in mean body weight (7 - 8 lbs) at week 24 compared with baseline. Overall, the ITCA 650 60 mcg/day dose produced robust reductions in HbA1c and appeared to be better tolerated than the 80 mcg/day dose. No patients discontinued treatment for any reason after dose escalation from 20 mcg/day up to 60 mcg/day.

Improvements in patient reported quality of life in patients receiving ITCA 650 in Stage I were maintained or increased during Stage II of the study. The greatest improvements in quality of life were reported among patients who switched from exenatide BID injections to ITCA 650. Based on these findings, 60 mcg/day was selected as the chronic dose for further evaluation in ITCA 650 Phase 3 studies.

"We have a high level of confidence that this analysis provides clear direction on the optimal dose regimen as we move ITCA 650 into global Phase 3 registration studies,” said Michelle Baron, MD, Intarcia's Chief Medical Officer. “We look forward to fully characterizing the clinical profile of ITCA 650. As the first injection-free GLP-1r agonist therapy, ITCA 650 holds the potential to help patients achieve 100% adherence to treatment. This should translate into more durable effects on HbA1c and weight with improved tolerability."

After the completion of the 24-week study, patients were offered the option to participate in an additional 24-week extension to evaluate longer term safety and durability of response. Patients continued to receive the dose of ITCA 650 that they received during Stage II. Eighty-five percent of the eligible patients entered the extension. The robust reductions in HbA1c and weight observed in the 24-week study were maintained throughout the additional 24-week extension with very favorable tolerability.

The global Phase 3 program planned for 2013 will evaluate treatment regimens with an initial dose of 20 mcg/day ITCA 650 for three months followed by a chronic dose of 60 mcg/day dose using longer duration ITCA 650 devices.

A downloadable version of the ITCA 650 phase 2 presentation from ADA is available on the Intarcia corporate website here:

2012 EASD DRAFT slide deck for Bob Henry

About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS continuous subcutaneous delivery of exenatide. The DUROS delivery technology comprises the DUROS device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy. Intarcia's proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature for extended periods of time.

The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 insertion. Unlike other extended delivery technologies, such as polymers or albumin fusions, DUROS delivery allows for steady state drug delivery upon insertion and near immediate withdrawal of therapy, if required. ITCA 650 is an investigational new drug and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, has been approved in the U.S., Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.

About Type 2 Diabetes
According to a June 2011 Lancet publication by Danaei and colleagues, an estimated 347 million adults worldwide had diabetes in 2008 and that number is expected to rise to 472 million by 2030. A significant portion of cases results from striking increases in countries like China and India, accounting for 138 million cases, the US and Russia, accounting for 36 million cases and an additional 42 million cases in Brazil, Pakistan, Indonesia, Japan and Mexico. Pre-diabetes, or impaired glucose tolerance (IGT), a condition that often leads to diabetes, affects a population that is roughly double the current diabetes population. The World Health Organization estimates deaths resulting from diabetes will double between 2005 and 2030 and estimates the global cost of diabetes to have exceeded $400 billion in 2010. United Healthcare expects spending on diabetes and diabetes-related care to reach $500 billion by 2020 in the US alone and projects the cumulative cost of diabetes care to reach $3.4 trillion over the next decade.

About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to ensure enhanced treatment outcome by optimizing patient adherence and improving the efficacy, convenience and tolerability of drug therapies. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above body temperature and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. Intarcia is pursuing a clinical stage development program for type 2 diabetes and has other programs for weight regulation to control obesity.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc. DUROS is a registered trademark of ALZA Corporation licensed to Intarcia Therapeutics, Inc. in certain fields.

 

INVESTOR CONTACT

Intarcia Therapeutics, Inc.
James Ahlers
james.ahlers@intarcia.com
(510) 782-7800

MEDIA CONTACTS

Intarcia Therapeutics, Inc.
Paulina Bucko
paulina.bucko@intarcia.com
(857) 880-1442

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