Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting
ITCA 650 induces potent reductions of HbA1c and body weight after 4 week treatment; ITCA 650 delivers up to 12 months of exenatide therapy from a single DUROS device
HAYWARD, Calif., Nov. 6 /PRNewswire/ -- Intarcia Therapeutics,
Inc. delivered two presentations today on its ITCA 650 (DUROS®
continuous delivery of exenatide) program for the treatment of type
2 diabetes at the Ninth Annual Diabetes Technology Meeting in San
Francisco, CA:
(Logo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO)
Continuous Subcutaneous Delivery of Exenatide Via ITCA 650
Lowers Plasma Glucose, HbA1c and Reduces Weight in a 28-day Phase
1b Study in Type 2 Diabetes, K. Luskey, J. McNally, J. Dahms, T.
Alessi
Stability of ITCA 650 for Continuous Subcutaneous Delivery of
Exenatide at Body Temperature for 12 Months, B. Yang, C. Negulescu,
R. D'Vaz, C. Eftimie, J. Carr, S. Lautenbach, K. Horwege, R.
Mercer, D. Ford, T. Alessi
Intarcia's ITCA 650 phase 1b clinical study was conducted at
multiple centers in the United States and evaluated a 28-day course
of ITCA 650 treatment among in patients with type 2 diabetes on a
stable treatment regimen of diet and exercise or treatment with
metformin and/or thiazolidinediones. The study included 4 dose arms
(10-12 patients/dose arm) to which patients were randomized to
receive 10 mcg/day, 20mcg/day, 40 mcg/day or 80 mcg/day of
exenatide for a 28-day treatment duration. ITCA 650 therapy was
administered for the full course of treatment with a single
insertion of the ITCA 650 on day 1 and removal on day 29.
Fasting & Postprandial Glucose ITCA 650 Dose Arms (continuous daily dose)
-----------------------------------------
10 20 40 80
mcg/day mcg/day mcg/day mcg/day
--------- --------- --------- --------
Mean FPG at baseline (mg/dL) 161.2 170.5 171.8 145.1
--------------------------- ----- ----- ----- -----
Mean FPG at end of treatment
(mg/dL) 155.6 139.4 129.8 116.3
---------------------------- ----- ----- ----- -----
Change from baseline (mg/dL) -5.6 -31.1* -42.0* -28.8*
--------------------------- ---- -------- -------- -------
Change in 2-hr PPG at end
of treatment (mg/dL) -16.3 -34.7* -47.1* -69.6*
------------------------- ----- -------- -------- -------
*p = < 0.05
Substantial decreases in FPG and PPG were observed throughout
treatment. Decreases in FPG were evident within 24 hours after
initiation of treatment, suggesting a rapid and consistent
achievement of desired exenatide levels with DUROS delivery.
Changes in PPG measured at days 15 and 29 also showed consistent
dose-dependent reductions. Changes from baseline in FPG and PPG
were statistically significant for the 20 mcg/day, 40 mcg/day and
80 mcg/day doses.
HbA1c & Body Weight ITCA 650 Dose Arms (continuous daily dose)
-----------------------------------------
10 20 40 80
mcg/day mcg/day mcg/day mcg/day
--------- --------- --------- --------
% HbA1c at baseline 7.67 7.90 7.45 7.38
------------------- ---- ---- ---- ----
% HbA1c at end of treatment 7.15 7.28 7.00 6.80
--------------------------- ---- ---- ---- ----
Change from baseline -0.54* -0.62* -0.45* -0.73*
--------------------------- ----- ----- ----- -----
Mean change in weight (kg) -0.27 -0.28 -1.13 -3.09*
------------------------- ----- ----- ----- -----
*p = < 0.05
Although the treatment duration in the study was only 28 days,
decreases in HbA1c and body weight were observed across all dose
arms. Changes in HbA1c from baseline were statistically significant
across all treatment arms. The most commonly reported adverse
events were nausea and vomiting, which were mostly mild, transient,
dose dependent and limited to the first week of therapy.
"The results from the phase 1b study demonstrate a pronounced
effect on HbA1c and body weight after just 4 weeks of treatment
with ITCA 650," said Kenneth L. Luskey, MD, Chief Medical Officer
at Intarcia. "ITCA 650 holds the potential to deliver much longer
durations of continuous therapy from a single device, and that is
currently under clinical investigation."
In addition to its phase 1b clinical data, Intarcia also
presented for the first time results of studies demonstrating the
ability of DUROS delivery technology to maintain stability of
exenatide at human body temperature and to continuously deliver
exenatide for as long as 12 months from a single DUROS device.
Purity of exenatide was maintained at levels above 99% for all time
points at both room temperature and human body temperature, and
bioactivity of exenatide was unchanged throughout the 12-month
study duration.
"These studies show that ITCA 650 can deliver 6, 9, or 12 months
of exenatide from a single DUROS device," said Thomas Alessi, PhD,
Vice President, Development and Manufacturing at Intarcia. "DUROS
delivery is designed to provide important clinical advantages to
patients and physicians by eliminating the need for self-injection,
ensuring 100% compliance and improving tolerability and
convenience."
Intarcia is currently conducting a 3-month phase 2 study
comparing ITCA 650 with twice-daily Byetta® exenatide
injections among a larger population of type 2 diabetes patients.
The goals of the ITCA 650 program are to enhance the therapeutic
effects of exenatide by ensuring patient compliance; provide more
consistent, around-the-clock therapeutic drug levels; and reduce
side effects, including nausea associated with high peak levels of
exenatide exposure observed with repeated injections.
About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS
continuous delivery of exenatide. The DUROS delivery technology
comprises the patented 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. The DUROS
technology can deliver up to one year of therapy from a single ITCA
650 insertion. Unlike other extended delivery technologies, such as
polymer encapsulation or albumin fusion, DUROS delivery allows for
steady-state drug delivery upon insertion and near immediate
withdrawal of therapy, if required. Exenatide, the active agent in
ITCA 650, has been approved in the US, Europe and many other
markets and is currently marketed as a twice-daily, self-injection
therapy for type 2 diabetes.
About Intarcia
Intarcia Therapeutics, Inc. is a privately held
biopharmaceutical company developing therapies to ensure enhanced
treatment outcome by optimizing patient adherence and improving the
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 clinical stage development programs for type 2 diabetes
and hepatitis C.
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. Byetta is a registered trademark of Amylin Pharmaceuticals,
Inc.
Photo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO
http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Source: Intarcia Therapeutics, Inc.
CONTACT: James Ahlers, Intarcia Therapeutics, Inc.,
+1-510-782-7800,
james.ahlers@intarcia.com
Web Site: http://www.intarcia.com/
Posted: November 2009
