Proteus Digital Health, Inc. Presents Interim Results At American College of Cardiology From A Randomized Controlled Clinical Study Of Proteus Discover

Digital Medicines Study Demonstrates Patients Benefit from Feedback on Medication Adherence and Behavior Patterns

CHICAGO--(BUSINESS WIRE)--Proteus Digital Health presented interim results from a randomized controlled study of Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes at the 65th Annual American College of Cardiology meeting. Proteus Discover, a digital medicine offering, consists of sensor-enabled medicines, a small wearable sensor patch, and applications for patients and clinical care givers. Proteus Discover directly measures medication-taking and physiology to support patient self-management and helps physicians and their care teams optimize therapy. This study builds upon evidence gained through 66 studies across diverse patient populations to assess accuracy, safety, and feasibility of use of Proteus Discover in patients with diseases such as hypertension and diabetes.

“The findings suggest that deploying a panel of medicines that reflect the needs of patients and physicians can move the needle in treatment optimization.”

Patients with uncontrolled hypertension, diabetes, and hypercholesterolemia are at high-risk for cardiovascular events and costly interventions. Controlling these diseases has been shown to reduce the risk of these complications.^1,2 Nearly half of patients with hypertension and type 2 diabetes fail to achieve treatment goals. Medication non-adherence, poor patient engagement, or lack of treatment optimization are major reasons for patients failing to achieve their treatment goals.^3-8 The study enrolled patients with these risk factors to understand whether a digital health offering including digital medicines improves clinical outcomes and treatment effectiveness.

This interim analysis revealed that patients with uncontrolled hypertension and diabetes who used Proteus Discover achieved statistically greater reduction in blood pressure (BP) and low-density lipoprotein-cholesterol (LDL), known risk factors for cardiovascular events, and were more likely to achieve their BP goal than usual care.

“The promising results from the pilot study demonstrate that this innovative digital approach to therapy optimization is not only patient-centered, but can lead to improved clinical outcomes,” said George Savage, Chief Medical Officer of Proteus Digital Health. “The findings suggest that deploying a panel of medicines that reflect the needs of patients and physicians can move the needle in treatment optimization.”

In this 12-week, IRB-approved study, 96 patients (mean age 58; 50% male) were enrolled with uncontrolled hypertension (systolic blood pressure [SBP] =140 mm Hg) and type 2 diabetes (A1C =7%) who had failed at least two anti-hypertensive medications plus metformin and/or sulfonylurea. Subjects received Proteus Discover for 4 or 12 weeks, or usual care based on a cluster randomized study design. The primary outcome was change in SBP at week 4. Secondary outcomes included change in diastolic blood pressure and proportion of subjects at BP target (<140/90 mm Hg). The study also explored change in LDL in a subset of patients on sensor-enabled atorvastatin. In this interim analysis, BP and LDL outcomes at week 4 were evaluated.

By week 4, 85% of those subjects using the digital medicine offering (n=72) and 33% of the usual care arm (n=24) achieved the BP target. Proteus Discover users had a greater reduction in SBP than usual care (digital medicine: -23±2 mm Hg; usual care: -14±4 mm Hg). The digital medicine offering arm also had a greater reduction in DBP (digital medicine: -9±2 mm Hg; usual care: -5±2 mm Hg). The LDL changes were -18±7 for digital medicine vs. 1±2 mg/dL for usual care; baseline mean LDL levels were 110±4 and 97±5 mg/dL respectively.

Full results of the clinical evaluation will be published later this year. Proteus is also partnering with customers to generate real-world clinical and economic evidence of this digital approach to treatment optimization and improved clinical outcomes.

How Proteus Discover works: A patient’s medications are co-encapsulated through specialty pharmacy services with an Ingestible Sensor, which is the size of a grain of sand and is activated when it reaches the stomach. The Ingestible Sensor communicates with a small wearable sensor patch worn by the patient. The patch records the time of ingestion and personalized data such as heart rate, physical activity, and rest. This information is seen by the patient through a mobile app, which provides insight to the patient to stay on track with therapy and allows them to share their data with their healthcare professional. Physicians and their care teams can access an online portal where they are provided with data insights that can help them personalize and optimize the patient’s treatment.

About Proteus Discover®

Proteus Discover is an innovative Digital Medicine offering that includes drugs that communicate when they’ve been taken, wearable sensors that capture physiologic response, applications that support patient activation and physician decision making, and data analytics to serve the needs of health systems. The FDA cleared Ingestible Sensor, which is the size of a grain of sand, is co-encapsulated (placed into a capsule) with the patient’s prescribed medications by a pharmacist, based on a healthcare provider’s prescription. When a patient takes the co-encapsulated medication, the Ingestible Sensor sends a signal to the small wearable patch, which records the time each pill is swallowed and also collects physiologic metrics such as heart rate, physical activity, and rest. While the co-encapsulation model is on the market today, Proteus and the company’s partners are undergoing further FDA review for a panel of Digital Medicines, where the ingestible sensor is directly integrated into the medication.

About Proteus Digital Health®

Headquartered in Redwood City, Calif., Proteus is privately held and funded by leading institutional and corporate investors, including: Novartis, Otsuka, Oracle and Sutter Health. For more information, visit www.proteus.com.

References:

1. American Diabetes Association. (8) Cardiovascular disease and risk management. Diabetes Care 2015; 38 Suppl:S49-57.
2. CDC. Chronic Diseases: The Leading Causes of Death and Disability in the United States. Available at: http://www.cdc.gov/chronicdisease/overview/
3. Go AS, et al. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation 2014;129(3):e28-e292.
4. Egan BM, Li J, Qanungo S, Wolfman TE. Blood pressure and cholesterol control in hypertensive hypercholesterolemic patients: National Health and Nutrition Examination Surveys 1988-2010. Circulation 2013; 128(1):29-41.
5. Selvin et al. Trends in Prevalence and Control of Diabetes in the U.S., 1988-1994 and 1999-2010. Ann Intern Med 2014; 160(8):517–525.
6. Sabaté, Eduardo. Adherence to long-term therapies: evidence for action. World Health Organization, 2003.
7. Remmers C, Hibbard J, Mosen DM, Wagenfield M, Hoye RE, Jones C. Is patient activation associated with future health outcomes and health care utilization among patients with diabetes? J Ambul Care Manage. 2009;32(4)320-7.
8. Lebeau et al. The concept and definition of therapeutic inertia in hypertension in primary care: a qualitative systematic review. BMC Family Practice 214; 15:130-139.