Intarcia Therapeutics, Inc.'s Once-A-Year Diabetes Drug ITCA 650 Impresses In Phase 3 Trial
6/16/2014 7:06:24 AM
Intarcia Presents Interim Phase 3 Data at ADA Showing ITCA 650, A Once Yearly GLP-1, Markedly Reduces Blood Sugar in Patients With Very Poorly Controlled Diabetes
* The average HbA1C reductions in patients treated with ITCA 650 for 6 months at the time of the interim analysis were -3.2%; patients at baseline had HbA1C levels between 10-12%.
* Intarcia’s global phase 3 program for ITCA 650 remains on track; first pivotal phase 3 data are expected in September for both the HBL study reported in today’s presentation, as well as the FREEDOM 1 placebo-controlled phase 3 trial.
* An oral presentation of FREEDOM 1 HBL results will be made at the European Association for the Study of Diseases (EASD) in Vienna this September.
BOSTON, MA – June 15, 2014 – Intarcia Therapeutics, Inc. today announced the highlights of a poster presentation at the 74th Scientific Sessions of the American Diabetes Association (ADA) held in San Francisco that contained the first 6-month data from an ongoing open-label phase 3 trial with ITCA 650 in type 2 diabetes. Patients in the trial had longstanding disease and significantly elevated HbA1C levels between 10%-12% despite treatment that included diet, exercise and antidiabetes medications. Nearly 70% of patients in the trial at baseline had very poor glucose control despite being treated with 1, 2 and even 3 oral diabetes therapies. The interim data showed marked improvements in glycemic control among patients with severe hyperglycemia and longstanding type 2 diabetes.
“I’m very excited about the data from today’s presentation because I believe it clearly shows the potential for ITCA 650 to offer the world a transformational new way to gain better control of their type 2 diabetes – an epidemic with enormous human and financial costs,” said Robert Henry, M.D., Chief, VA Endocrinology & Metabolism, and Professor of Medicine in Residence at UCSD. “The most striking aspect of the interim data is the sheer magnitude of positive clinical responses seen, and the fact that this scale of improvement is being seen in patients who would be considered recalcitrant to therapeutic efforts to achieve glycemic control. A once or twice yearly, injection-free therapy with these interim findings holds great promise, and if approved could bring a world of difference for a tremendous number of patients currently struggling with poorly controlled type 2 diabetes.”
According to the recently published DHHS “Healthy People 2020: Report Card on the Health of the Nation,” the number of diagnosed diabetes patients who have an HbA1C blood sugar level higher than nine percent (9%) increased from 18% in 2005-2008 to 21% in 2009-2012 – or more than one in five patients. This increase in the number of very poorly controlled patients in such a short time span reinforces the epidemic proportions of this disease and the challenges of achieving glycemic targets and sustaining them over time in the face of poor patient compliance and adherence with current therapeutic interventions.
Detailed Data about the Interim Results from FREEDOM 1 HBL
The data includes the first 6-month, open-label experience with ITCA 650 mini-pumps from an ongoing multicenter study in subjects with type 2 diabetes who did not meet enrollment criteria for the double-blind placebo controlled trial because their HbA1C was greater than 10%, a population who is not appropriate for a placebo controlled trial. This open-label HBL study enrolled a total of 60 patients who met all of the qualifications for the double-blind study except for elevated blood sugar levels and an HbA1C between 10-12%. Entrance criteria for the open-label trial included: HbA1C >10% to =12%, age 18-80 years, BMI 25-45 kg/m2, a stable regimen (=3 months) of diet and exercise and/or mono, or combination therapy with any combination of metformin, sulfonylurea, and thiazolidinedione. Sixty-nine percent (69%) of the subjects – almost 7 out of 10 patients – were on one or more diabetes medicines at baseline and still very poorly controlled.
Treatment was initiated by placing a 3-month ITCA 650 mini-pump delivering 20 mcg/day, which was then replaced by a 6-month ITCA 650 mini-pump delivering 60 mcg/day for 26 weeks. Pre-study oral anti-diabetic agents (OADs) were maintained unchanged for the 39 weeks of treatment. The primary endpoint in the trial is: Change in HbA1C from baseline to week 39.
At the time of the initial interim analysis, fifty patients completed 13 weeks, thirty-nine patients completed 19 weeks, and twenty-five patients completed 26 weeks. Mean baseline characteristics for the entire cohort (n=60) were: HbA1C 10.7%, age 52.1 yrs, BMI 32.1 kg/m2, duration of diabetes 8.9 yrs, OADs use 69%. Mean reductions of HbA1C at Weeks 13 (n=50), 19 (n=39), and 26 (n=25) were -2.5%, -2.9%, and -3.2%, respectively. HbA1C reductions =2% were achieved by 78% of subjects who completed at least 13 weeks of treatment; 50% achieved >3% and 22% achieved =4% reductions. HbA1C targets of <7% were achieved in 26% of subjects who had completed at least 13 weeks of treatment. Adverse events were consistent with previous trials with ITCA 650. The interim analysis shows ITCA 650 has the potential to dramatically improve glycemic control in patients with severe hyperglycemia and longstanding diabetes.
About ITCA 650
ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.
Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1C and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily and once weekly self-injection therapy for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia’s robust intellectual property portfolio protects ITCA 650 through 2031. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and presents when the body either does not produce enough insulin or becomes resistant to insulin, resulting in high levels of blood sugar. According to a June 2011 Lancet publication by Danaei and colleagues, an estimated 347 million adults worldwide suffered from type 2 diabetes in 2008; that number is expected to rise to 472 million by 2030. It is estimated that pre-diabetes (impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG)) a condition that often leads to diabetes, affects a population roughly twice the size of the current diabetes population. The World Health Organization estimates deaths resulting from diabetes will double between 2005 and 2030 and estimates the global cost of diabetes to have exceeded $400 billion in 2010. United Healthcare expects spending on diabetes and diabetes-related care to reach $500 billion by 2020 in the U.S. alone, and projects the cumulative cost of diabetes care will reach $3.4 trillion over the next decade.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, eliminating the need for life-long injections, ensuring compliance and persistency over time with up to once-yearly dosing, and by improving the tolerability of drug therapies. Delivering medicines just once or twice yearly virtually ensures patient compliance and persistency, which is very poor in most chronic diseases. 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 Intarcia's proprietary technology platforms. Intarcia is conducting a Phase 3-stage development program for type 2 diabetes and has additional early development programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
ALERT TO MEDIA
Efficacy and Tolerability of ITCA 650 (Continuous Subcutaneous Exenatide) in Poorly Controlled Type 2 Diabetes with Baseline HbA1C>10%
R. Henry, J. Rosenstock, M. Baron
Sunday, June 15
12:00 noon – 2:00 pm
Late Breaking Studies
Poster Hall (Hall D-North)
Speaker: Robert Henry, M.D., former President of the ADA, and current Chief, VA Endocrinology & Metabolism and Professor of Medicine in Residence at UCSD, will be available to discuss the interim data and answer related questions.
Downloadable Copies of Poster Session Data Available:
The poster is available for download at: www.intarcia.com/documents/14-442-ADA-ITCA-650_v2.pdf
Intarcia Therapeutics, Inc.
(510) 782-7800 (office)
(973) 998-6949 (office)
(973) 800-2530 (cell)
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