Intarcia Therapeutics, Inc. Presents Positive ITCA 650 Phase 2 Study Results as a Late-Breaker at the American Diabetes Association 70th Scientific Sessions
Study evaluates two doses of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) compared with Byetta® (twice daily injections of exenatide)
HAYWARD, Calif., June 28 /PRNewswire/ -- Intarcia Therapeutics,
Inc. presented today the results of a phase 2 clinical study of
ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide)
for the treatment of type 2 diabetes as a late-breaker at the
Annual Conference of the American Diabetes Association in Orlando,
FL (June 25-29, 2010). Results of the phase 2 study demonstrated
substantial reductions in HbA1c and body weight during the 12 weeks
of treatment with ITCA 650 at both the 20 mcg/day and 40 mcg/day
doses.
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The phase 2 study was conducted at 50 centers in the United
States and evaluated a 12-week course of two doses of ITCA 650
compared with twice daily injections of exenatide (Byetta®)
among 155 type 2 diabetes patients (51-53 patients/arm) on a stable
treatment regimen of metformin. The study included three dose arms
to which patients were randomized to receive either ITCA 650 at
doses of 20 mcg/day or 40 mcg/day, or twice daily injections of
exenatide at 5 mcg BID for 4 weeks followed by 10 mcg BID
thereafter as indicted in the product label.
Summary of week 12 results
ITCA 650 20 ITCA 650 40 Exenatide
mcg/day mcg/day injection
Mean baseline HbA1c 7.90 8.00 8.01
Mean week 12 HbA1c 6.94 6.96 7.19
Change from baseline -0.96 -1.04 -0.82
% HbA1c < 7.0 64% 68% 51%
--------------------
% HbA1c < 6.5 32% 26% 17%
-------------
Mean baseline body weight 93.5 kg 91.5 kg 93.4 kg
Mean % change in body
weight at week 12 -0.87% -2.62% -1.54%
--------------------- ----- ----- -----
DUROS continuous delivery of exenatide resulted in a reduced
incidence and persistence of treatment-associated nausea. Nausea
rates among patients receiving ITCA 650 at 40 mcg/day were similar
to those receiving exenatide injections at 10 mcg BID. Nausea rates
observed among patients receiving ITCA 650 at 20 mcg/day were lower
than patients receiving the same daily dose with BID
injections.
The phase 2 study also incorporated a quality of life (QOL)
assessment (DM-SAT) completed by each patient prior to initiating
treatment and again at treatment week 8. The results of this
assessment suggest that patients receiving either dose of ITCA 650
experienced greater improvement in their quality of life compared
to patients receiving twice daily injections of exenatide.
ITCA 650 20 ITCA 650 40 Exenatide
mcg/day mcg/day injection
------- ------- ---------
% improvement in patient-assessed
QOL at week 8 25% 40% 15%
---------------------------------- --- --- ---
Other clinical observations from the phase 2 study include
reductions in both LDL-C and systolic blood pressure from baseline.
Approximately 92% of patients completed treatment, and
discontinuation rates ranged from 5.9% on ITCA 650 at 40 mcg/day to
9.4% on exenatide twice daily injection.
ITCA 650 20 ITCA 650 40 Exenatide
mcg/day mcg/day injection
Change in LDL-C -4.8 mg/dL -5.4 mg/dL +1.2 mg/dL
--------------- ---------- ---------- ----------
Change in systolic blood
pressure -3.6 mmHg -6.8 mmHg -4.2 mmHg
------------------------ --------- --------- ---------
"The results of the phase 2 study suggest that ITCA 650 may play
an important role in the treatment of type 2 diabetes," said Dr.
Robert Cuddihy, MD, Medical Director, International Diabetes Center
at Park Nicollet in Minneapolis, MN and a study investigator who
presented the results at the ADA meeting. "Compliance is a
significant challenge for many patients, and ITCA 650 ensures the
delivery of every dose everyday. No other treatment can do
that."
In an ongoing 12-week extension phase of the study, patients
receiving ITCA 650 were randomized to remain on their current dose
or increase their ITCA 650 dose; patients receiving twice daily
injections of exenatide were switched to ITCA 650 therapy at one of
two doses. The dosing and treatment changes have been well
tolerated and the interim week 20 HbA1c results are presented
below.
Summary of week 20 interim HbA1c results including 108 patients
who have completed 20 weeks of treatment to date:
ITCA 650 20 ITCA 650 40 ITCA 650 60 ITCA 650 80
Week 20 mcg/day mcg/day mcg/day mcg/day
Mean baseline
HbA1c 7.88 7.83 8.06 8.07
Mean week 20
HbA1c 7.03 6.77 6.79 6.68
Change from
baseline -0.85 -1.06 -1.27 -1.39
% HbA1c < 7.0 50% 79% 74% 76%
------------- --- --- --- ---
% HbA1c < 6.5 20% 46% 47% 53%
------------- --- --- --- ---
"Our experience in the phase 2 study demonstrates that ITCA 650
is a very well-tolerated treatment option that can be administered
in a physician's office by both specialists and primary care
physicians," said Kenneth L. Luskey, MD, Intarcia's Chief Medical
Officer. "A phase 3 study of ITCA 650 is planned for the fourth
quarter of this year. In the trial we intend to confirm the Phase 2
results on a larger scale and for a longer duration to further
evaluate the glucose lowering effects and tolerability 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 around day 90. The extension phase of the 2
trial evaluates higher doses of ITCA 650 using a single device to
deliver 3 months of treatment. The phase 3 study planned for later
this year will evaluate longer duration ITCA 650 devices.
At the time of the presentation, data were available on 108/155
patients who have completed 20 weeks of treatment. All patients are
expected to complete the 12-week extension phase of the study in
July 2010 and the results of the extension phase will be presented
at the 46th Annual Meeting of the European Association for the
Study of Diabetes in Stockholm, Sweden in September 2010.
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. 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, 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 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. 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 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.
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PRN Photo Desk, photodesk@prnewswire.com/
Source: Intarcia Therapeutics, Inc.
CONTACT: James Ahlers, Intarcia Therapeutics, Inc.,
+1-510-82-7800,
james.ahlers@intarcia.com
Web Site: http://www.intarcia.com/
Posted: June 2010
