DUROS(R) continuous delivery of exenatide produces impressive reductions in fasting plasma glucose, HbA1c and body weight during 28-day treatment
"This study was designed to evaluate a more effective and patient-friendly approach to deliver exenatide therapy for the treatment of type 2 diabetes," said
The phase 1b dose ranging study was conducted at multiple centers in
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) -8.8 -32.3 -47.1 -74.6
Substantial decreases in FPG and PPG were observed throughout treatment. Decreases in FPG were evident within 24 hours of the 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.
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 -0.52 -0.62 -0.45 -0.58 Mean change in weight (kg) -0.28 -0.31 -0.93 -2.91
Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. The most commonly reported adverse events were nausea and vomiting which were mostly mild, transient and dose dependent.
"The results from the ITCA 650 phase 1b study have provided important guidance toward dose selection and study design for continuing clinical development," said
ITCA 650 therapy in this phase 1b trial was administered for the full course of treatment with a single insertion of the ITCA 650 on day 1 and removal on day 29. The phase 2 trial will evaluate ITCA 650 against the current standard of care for a longer duration of treatment and 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 and providing more consistent, round-the-clock therapeutic drug levels; and to 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 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,
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.
MEDIA CONTACT Intarcia: James Ahlers Intarcia Therapeutics, Inc. (510)782-7800 firstname.lastname@example.org
SOURCE Intarcia Therapeutics, Inc.