Intarcia Reveals New Insights At EASD Meeting Characterizing The Burden Of Poor Control And Non-Adherence To Anti-Diabetic Therapies

VIENNA, Sept. 17, 2014 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the presentation of compelling, quantitative data from a study of the cost and predictability of non-adherence in type 2 diabetes therapies at the 50^th Annual Meeting of the European Association for the Study of Diabetes (EASD). In a poster session today, Christian Frois, Ph.D., of Analysis Group, Inc. presented data from the first in a series of planned Intarcia-sponsored, retrospective studies to characterize the prevalence of non-adherence and serial non-adherence, identify key predictors of non-adherence to anti-diabetic therapy, and quantify the economic burden associated with poor control due to non-adherence and healthcare costs. Truven Health MarketScan® Commercial Claims and Encounters database, one of
the largest claims-based databases in the U.S., was used for the study.

"Despite advances in the treatment of type 2 diabetes and efforts by the medical community to improve patient adherence with therapy," said Christian Frois, Ph.D., "today more than half of all people with type 2 diabetes are unable to adhere to their regimens, and less than half of all patients achieve or maintain glycemic control (HbA1c less than 7%). Non-adherence is a major contributor to this alarming percentage of poorly controlled patients. These data represent a first step to quantify the true burden of non-adherence, and also define a patient profile that may allow clinicians to predict which patients are more likely to be non-adherent so management strategies and treatment selections can be tailored early on to improve clinical outcomes."

Highlights from the presentation, "The Burden of 'Serial Non-adherence' in Type 2 Diabetic Patients," include the following:

• A total of 46,789 patients who had been prescribed a second-line anti-diabetes therapy for at least 12 months were included in the retrospective claims analysis.
• Adherence Data
  • Most patients (58%, N=27,161) were non-adherent to anti-diabetic therapy during the first year after initiating second-line therapy.
  • Forty-six percent of patients were non-adherent to both first- and second-line type 2 diabetes therapies.
  • Sixty-nine percent of patients non-adherent to first-line anti-diabetic therapy were not adherent to second-line.
• Cost of Non-Adherence
  • Non-adherence to second-line therapy was associated with a 20% increase in the rate of observed visits for hypoglycemia (2.9% vs. 3.5%; p<0.001); non-adherence was further associated with a 53% increase in the rate of observed severe hypoglycemic events (0.6% vs. 0.9%, p<0.001).
  • During the 12 months following initiation of second-line therapy, non-adherence to a second-line diabetes regimen was associated with a significant medical cost burden after controlling for baseline differences in patients; average annual medical costs were 30% ($2,432) higher for non-adherent patients than adherent patients, driven largely by 70% ($1,678) higher hospitalization costs for non-adherent patients than adherent patients (p<0.0001 for both).
• Predictive Value of Data
  • Between 16% and 24% of patients were serially non-adherent to both diabetes and non-diabetes medications.
  • Among patients who had been non-adherent to both first-line metformin and second-line anti-diabetes therapy, more than half of those prescribed other non-diabetes medication demonstrated a similar pattern with those medications. This consistent pattern of "serial non-adherence" was highly predictive of non-adherence to second-line therapy for type 2 diabetes.
  • Among factors observed prior to the start of second-line therapy, serial non-adherence had by far the greatest association with second-line non-adherence (OR: 4.67; 95% CI: 4.37 – 5.00; p<0.0001) and accounted for a large fraction of the explained variance (65%), followed by first-line (metformin) non-adherence (OR: 2.29; 95% CI: 2.13 – 2.47; p<0.0001) and non-diabetic medication non-adherence (OR: 1.38; 95% CI: 1.28 – 1.50; p<0.0001).
• Study Conclusions
  • The burden of non-adherence in type 2 diabetes may be more significant than is currently understood to be the case, and was found to be associated with higher risk of hypoglycemia and higher medical care costs even in a short-term analysis.
  • Since prior non-adherence is observable and appears to be highly predictive of later non-adherence, intervention strategies that target non-adherent and serially non-adherent patients early in treatment may be particularly effective in improving their long-term outcomes by introducing more effective control strategies earlier before irreversible damage is done.
  • Further studies are planned to analyze the effects of non-adherence on HbA1c levels, weight and other clinical factors.

Intarcia is developing its lead candidate ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes. ITCA 650 is a matchstick-sized osmotic pump implanted sub-dermally that can deliver up to 12 months of continuous and consistent therapy of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. With its unique delivery system, Intarcia aims not only to improve the lives of type 2 diabetes patients, but also to reduce concerns associated with patient compliance to current therapy. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM; the first results from the FREEDOM-1 and FREEDOM-HBL (high baseline) phase 3 studies are expected to be reported in the fourth quarter of this year.

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 implanted 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 up to 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, and the first results from the FREEDOM-1 and FREEDOM-HBL (high baseline) phase 3 studies are expected to be reported in the fourth quarter of this year.

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.

SOURCE Intarcia Therapeutics, Inc.