2014

Intarcia Presents Compelling 48-week Results for ITCA 650 - Data Underlines the Promise to Become the First Injection-free GLP-1 Therapy at the 47th Annual EASD Meeting in Lisbon — ITCA 650, injection-free continuous delivery of GLP-1 therapy, demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI AEs typically associated with this class —

—Global phase 3 program commencing in late 2011 intended to demonstrate superiority vs. current standards of care —

HAYWARD, Calif., Sept. 14, 2011 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the presentation of final 48-week results from a phase 2 clinical study of ITCA 650 (DUROS® subcutaneous continuous delivery of exenatide) for the treatment of type 2 diabetes at the 47th Annual Meeting of the European Association for the Study of Diabetes in Lisbon, Portugal.

(Logo:  http://photos.prnewswire.com/prnh/20050301/SFTU126LOGO)

Results of the phase 2 study, presented by Julio Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine at the University of Texas Southwestern Medical School, demonstrate that patients receiving treatment with ITCA 650 experienced substantial and sustained reductions in HbA1c, fasting plasma glucose (FPG) and body weight during the 48 weeks of treatment at all doses. ITCA 650 20 mcg/day provided improved glycemic control with the most favorable tolerability profile as a starting dose for weeks 1 through 12. Subsequent transition to ITCA 650 doses of 40, 60 or 80 mcg/day led to statistically significant reductions in HbA1c, FPG and body weight after 24 and 48 weeks of treatment.  

"While injectable GLP-1s have produced some great data, we are very excited about raising the bar and changing the game with ITCA 650's breakthrough delivery system. The 48-week phase 2 results showed excellent glucose control and weight loss together with a marked reduction in the GI AEs typically associated with injectable GLP-1s. Added to that, ITCA 650's once or twice yearly dosing schedule will virtually guarantee patient compliance and adherence," said Kurt Graves, Executive Chairman of the Board of Directors of Intarcia. "ITCA 650 holds new promise for many type 2 diabetes patients and their physicians who want meaningful glucose reductions and a favorable weight profile without the tolerability and poor compliance trade-offs associated with life-long and frequent self-injections." Graves added, "ITCA 650's 48 week results support our planned phase 3 superiority studies intended to shape a new and compelling value proposition so desperately needed for patients, providers and payors alike."

Study Design and Summary of Week 48 Results

The phase 2 study enrolled 155 type 2 diabetes patients (51-53 patients/arm) across 50 centers in the United States. Prior to study entry, patients were on a stable treatment regimen of metformin monotherapy that was continued throughout the study.  The study compared six different regimens of ITCA 650 to optimize dose and regimen for further evaluation in phase 3 studies.

After an initial 12-week treatment period comparing ITCA 650 20 mcg/day and 40 mcg/day with twice-daily injections of exenatide, patients continued treatment with one of 4 doses of ITCA 650: 20, 40, 60 or 80 mcg/day in the following manner through the planned 24-week endpoint:

Treatment Weeks 1 – 12

Treatment Weeks 13 - 24

ITCA 650 20 mcg/day  -->

ITCA 650 20 mcg/day

ITCA 650 20 mcg/day  -->

ITCA 650 60 mcg/day



ITCA 650 40 mcg/day  -->

ITCA 650 40 mcg/day

ITCA 650 40 mcg/day  -->

ITCA 650 80 mcg/day



Exenatide BID injection  -->

ITCA 650 40 mcg/day

Exenatide BID injection  -->

ITCA 650 60 mcg/day



Clinical sites were authorized to offer patients an extension of up to an additional 24 weeks of ITCA 650 treatment to evaluate longer term safety and durability of response.  Among the sites participating in the extension phase, a total of 86 patients (85% of patients at these sites) elected to continue ITCA 650 therapy.

Sustained reductions in HbA1c, FPG and weight were observed across all treatment arms from week 24 through week 48. Reductions in HbA1c were greatest in the 60 mcg/day and 80 mcg/day dose arms but not statistically different between these two dose arms.

ITCA 650 dose weeks 13-48

20 mcg/day

40 mcg/day

60 mcg/day

80 mcg/day

Mean baseline HbA1c (%)

7.8

7.8

8.1

7.9

Mean week 48 HbA1c (%)

6.8

6.8

6.6

6.5

Mean HbA1c change at week 48 (%)

-1.0

-1.0

-1.5

-1.4

Mean weight change at week 48 (lbs)

-6.0

-10.8

-7.7

-7.9



Based on the robust treatment response observed at the week-24 study endpoint and the durability of response observed at week 48, a starting dose of ITCA 650 20 mcg/day for weeks 1-12 followed by transition to ITCA 650 60 mcg/day appears to provide the greatest incremental reductions in HbA1c, FPG and body weight with the most favorable tolerability profile.

Throughout the extended treatment duration of the study, there were no treatment discontinuations due to nausea.  Numeric improvements were observed in measures of blood pressure and lipids at weeks 24 and 48 compared to baseline.

"Testing novel therapies over longer treatment durations is very important to confirm sustained effects, safety and tolerability," said Julio Rosenstock, MD, ITCA 650 phase 2 study principal investigator.  "These encouraging findings warrant further investigation of the optimized dose regimen of ITCA 650 20 to 60 mcg/day in larger phase 3 studies and using longer duration devices."  

Patient Satisfaction with ITCA 650 Therapy

In a separate session focusing on new GLP-1 therapies, Thomas R. Alessi, PhD, Intarcia's Vice President, Development, presented the results of a treatment satisfaction survey that was administered to patients before the beginning of the ITCA 650 phase 2 clinical study and at study weeks 8 and 20.  The survey utilized the Diabetes Medication Satisfaction Tool (DM-SAT), a validated and published self-assessment tool.  Study results indicated that patients receiving ITCA 650 at doses of either 20 mcg/day or 40 mcg/day experienced a statistically significant improvement in their quality of life after 8 weeks of ITCA 650 therapy compared with their level of satisfaction at study entry on oral metformin therapy. Patients on either dose of ITCA 650 also experienced a greater increase in their level of satisfaction with treatment compared with patients on twice-daily self-injections of exenatide.  Results of the week 20 assessment showed a statistically significant improvement in treatment satisfaction among patients switching to ITCA 650 from exenatide injection. The substantial improvement observed among patients initially randomized to ITCA 650 was maintained after transition to higher doses of ITCA 650.

ITCA 650 Pharmacokinetics and Pharmacodynamics

In the same session, Intarcia's Chief Medical Officer, Kenneth L. Luskey, MD, presented an analysis of pharmacokinetics and pharmacodynamics from the ITCA 650 48-week phase 2 study.  Results of the analysis confirmed that treatment with ITCA 650 achieves steady state plasma levels of exenatide within 24-48 hours and provides continuous exposure and consistent plasma levels of exenatide for up to 48 weeks.  Following removal of ITCA 650, exenatide levels became undetectable within 24 hours.  Nearly all patients responded to ITCA 650, and greater reductions in HbA1c, FPG and body weight were observed among patients with the highest plasma exenatide concentrations.

The ITCA 650 phase 3 program, planned for late 2011 initiation, will evaluate treatment regimens involving initial 3-month ITCA 650 dosing at 20 mcg/day transitioning to 60 mcg/day and thereafter using ITCA 650 devices of both 6- and 12-month durations.

A downloadable version of the ITCA 650 presentations from EASD are available on the Intarcia corporate website at: http://www.intarcia.com/media_presentations.html

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 placed subcutaneously to provide continuous and consistent drug therapy. Intarcia's proprietary formulation technology 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 placement. Unlike other extended delivery technologies, such as polymers or albumin fusions, DUROS delivery provides steady state drug delivery upon placement and allows for near immediate cessation 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 other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.  Intarcia's robust worldwide patent portfolio extends protection of ITCA 650 through at least 2027.

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

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 body temperature and to deliver them in a constant and consistent manner via its 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.

SOURCE Intarcia Therapeutics, Inc.



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