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Intarcia Therapeutics, Inc. Presents Positive Phase 2 48-week Results From ITCA 650 Study at the American Diabetes Association 71st Scientific Sessions


6/28/2011 11:11:15 AM

HAYWARD, Calif., June 28, 2011 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the presentation of final 48-week results of a phase 2 clinical study of ITCA 650 (DUROS® subcutaneous continuous delivery of exenatide) for the treatment of type 2 diabetes at the American Diabetes Association's 71st Scientific Sessions in San Diego, California.

(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, demonstrated 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. A starting dose of ITCA 650 20 mcg/day for weeks 1 through 12 provided improved glycemic control with the best tolerability profile. Subsequent transition to ITCA 650 doses of 40, 60 or 80 mcg/day led to statistically significant improvements in HbA1c, FPG and body weight after 24 and 48 weeks of treatment.

"We are very encouraged by the robust results observed in this study and the high level of enthusiasm expressed by patients and investigators," said Kurt Graves, Executive Chairman of the Board of Directors of Intarcia. "ITCA 650 is a novel GLP-1 therapeutic approach for type 2 diabetes that holds new promise for many patients and physicians who want robust glucose reductions and a favorable weight profile without the trade-offs associated with having to start potentially life-long and frequent self-injections." Graves added, "ITCA 650 not only delivers sustained glycemic control and favorable weight effects but the breakthrough subcutaneous continuous delivery platform is being developed as just a once- or twice- yearly administration, offering promise to ensure patient compliance and provide the long-term control that is so desperately needed for patients, providers and payors alike."

The phase 2 study enrolled 155 type 2 diabetes patients (51-53 patients/arm) across 50 centers in the United States who were on a stable treatment regimen of metformin. The study compared six different regimens to find the optimal dose range and regimen to take into phase 3.

Study Design and Summary of Week 48 Results

After an initial 12-week treatment period comparing ITCA 650 20 mcg/day and 40 mcg/day with twice-daily injections of exenatide based on pre-study re-randomization, patients received 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 - 48

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



After the completion of the 24-week study, clinical sites were authorized to offer patients an extension of up to an additional 24 weeks of treatment to evaluate longer term safety and glycemic control. Thirty-five of the original 50 sites were able to participate in the extension study and a total of 86 patients (85% of those eligible from these sites) entered the extension study.

Continued reductions in HbA1c, FPG and weight were observed across all treatment arms at week 48 compared to week 24. Both incremental and aggregate reductions in HbA1c were greatest in the 60 mcg/day and 80 mcg/day dose arms but not measurably 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

-10.8

-7.7

-7.9



Based on the consistent results observed at the week 24 study endpoint and the week 48 extension, 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 most substantial 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 BP and lipids at weeks 24 and 48 compared to baseline.

"Testing novel therapies over longer treatment durations is very important to confirm sustained efficacy 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 - 60 mcg/day in large phase 3 studies and using longer duration devices."

Patient Satisfaction Survey

A treatment satisfaction questionnaire was administered to patients before the study and at study weeks 8 and 20. Results of the week 8 assessment suggested a higher level of satisfaction among patients receiving ITCA 650 20 mcg/day or ITCA 650 40 mcg/day compared with patients self-injecting exenatide twice daily. Results of the week 20 assessment showed a substantial improvement in treatment satisfaction among patients switching from exenatide injection to ITCA 650 and that the substantial improvement observed among patients initially randomized to ITCA 650 was maintained after transition to higher doses of ITCA 650.

ITCA 650 therapy in the phase 2 trial was administered for the 90-day treatment period with a single insertion of ITCA 650 on day 1 and removal on or about day 90. The extension phase of the 2 trial evaluated higher doses of ITCA 650 using a single device to deliver 3 months of treatment. The phase 3 study planned for 2011 will evaluate treatment regimens involving initial 12-week ITCA 650 dosing at 20 mcg/day transitioning to 60 mcg/day thereafter using ITCA 650 devices of both 6- and 12-month duration.

A downloadable version of the ITCA 650 phase 2 presentation from ADA is 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. Intarcia's delivery technology comprises the DUROS device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature for extended periods of time.

A single DUROS device can deliver up to a full year of ITCA 650 therapy. 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 the National Institutes of Health (NIH), "Approximately 23.6 million Americans have type 2 diabetes, which represents 7.8 percent of the U.S. population and about 1/4 of them don't even know it. In addition, we now know that at least another 57 million Americans have 'pre-diabetes.'" Diabetes is conservatively estimated to be the seventh leading cause of death in the U.S. Minority populations are disproportionately affected, particularly African Americans and Hispanics. For example, African Americans are 1.8 times more likely to develop type 2 diabetes compared to non-Hispanic whites.

According to the Centers for Disease Control and Prevention (CDC), the rate of new cases of type 2 diabetes has nearly doubled in the U.S. in the last decade with these new cases mirroring an increase in obesity rates - a leading cause of type 2 diabetes.

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 above 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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