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Intarcia Therapeutics, Inc. Commences
Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes
Head-to-head comparison of DUROS® continuous delivery of
exenatide vs. twice-daily Byetta® (exenatide) injections over
3-month treatment duration
Hayward, CA, Thursday, September 17, 2009/ Intarcia
Therapeutics, Inc. today announced the start of enrollment for a
phase 2 study comparing its proprietary drug candidate ITCA 650
(DUROS continuous delivery of exenatide) with Byetta, an
FDA-approved twice-daily injection form of exenatide. Building
upon the successful completion of a 28-day phase 1b study of
ITCA 650 in May of this year, the phase 2 study is intended to
evaluate the doses achieving the best results in the phase 1b in
a larger study population and for a longer duration of
treatment. In addition, an extension phase of the phase 2 study
will evaluate dose response of ITCA 650. Patients receiving
Byetta for the first 12 weeks will be switched from Byetta to
one of two doses of ITCA 650 to evaluate the potential for
improving treatment effect.
"We are very pleased with the rapid progress and positive
results achieved thus far in the ITCA 650 program" said Ken
Luskey, MD, VP, Clinical Research for Intarcia. "In 2009, we
expect to move the ITCA 650 program from IND-filing through
completion of phase 2 enrollment."
The ITCA 650 phase 2 study will involve 150 patients with
sub-optimally controlled type 2 diabetes treated with metformin.
Patients will be recruited at 50 clinical trial sites in the US
and will be randomized equally to receive one of two doses of
ITCA 650 or twice-daily injections of Byetta. Upon completion of
the 12-week course of treatment, patients on all three arms will
be further randomized to receive higher doses of ITCA 650 for an
additional 12 weeks. The extension phase will evaluate efficacy
and tolerability of higher doses of ITCA 650, as well as the
effects of switching patients from twice-daily injections of
Byetta to ITCA 650. The study will provide important information
to support dose selection for ITCA 650 phase 3 evaluation,
anticipated to begin in the second half of 2010. Additionally,
this phase 2 study will provide important insights into future
clinical use of ITCA 650 with respect to switching patients from
injectable Byetta therapy to ITCA 650.
"We have received strong interest in the ITCA 650 program since
the late-breaker presentation of preliminary phase 1b study
results at the American Diabetes Association Conference in June"
said K. Alice Leung, President and CEO of Intarcia. "We intend
to select a commercial partner for ITCA 650 prior to the start
of phase 3 in the second half of 2010."
About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS
continuous delivery of exenatide. The DUROS delivery technology
comprises the proprietary 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 to
manage side effects, 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 human 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.
Media Contact
Intarcia
James Ahlers
Intarcia Therapeutics, Inc.
(510)782-7800 |