The First Phase 3 Clinical Trials of "Digital Therapeutics" for Hypertension Begin in Japan

Jichi Medical University and CureApp, Inc.
The First Phase 3 Clinical Trials of "Digital Therapeutics" for Hypertension Begin in Japan
Verifying the standalone therapeutic efficacy of the app in patients untreated with anti hypertensive drugs 
A new treatment for hypertension, the disease with the highest number of patients in Japan, incurring medical costs in the order of $17 billion USD

 CureApp, Inc. (Head Office, Chuo-ku, Tokyo; President and CEO, Kohta Satake, M.D.), developer of software as a medical device “Digital Therapeutics” mobile applications, has launched a Phase 3 multicenter, randomized comparative study (clinical trial) of "Digital Therapeutics“ for hypertension in Japan with various partners including Professor Kazuomi Kario, M.D., Ph.D., the Division of Cardiovascular Medicine, the Department of Medicine, and Jichi Medical University School of Medicine.

 This study will evaluate the efficacy and safety of "Digital Therapeutics" in patients with essential hypertension who have not received an orally administered antihypertensive drug treatment. Patients will be divided into two groups; those using "Digital Therapeutics" in addition to lifestyle changes set according to the Guidelines for the Management of Hypertension 2019 (the "Guidelines”) (*1), and those only adopting said lifestyle habit changes without using ”Digital Therapeutics”. The primary criteria for evaluation is the change from the baseline in mean 24-hour systolic blood pressure*1 at 12 weeks after treatment begins, as measured by ambulatory blood pressure monitoring (ABPM)*2.
*1 Systolic blood pressure: Highest blood pressure in blood pressure measurement
*2 Ambulatory blood pressure monitoring: Continuous measurement of blood pressure at certain intervals for 24 hours under normal lifestyle conditions. Blood pressure fluctuatesdue to various factors; this shows the daily variation in blood pressure (daily variation pattern).




Hypertension is the biggest risk factor for cerebrovascular and cardiovascular diseases (i.e. stroke, heart disease), and the annual death toll in Japan from these diseases attributed to hypertension is estimated to reach 100,000. The number of patients with hypertension in Japan is estimated approx.
43 million, and blood pressure is appropriately controlled in only 12 million of these patients (*1). The lifestyle improvements essential to hypertension treatment are difficult to sustain as they are largely dependent on a patient’s motivation or their workplace/home environment. At the same time, successful lifestyle intervention by medical institutions presents a challenge.
 

Under these circumstances, "Digital Therapeutics," a new treatment method utilizing mobile technology, aims to produce a strong therapeutic effect enabling patients to return to normal blood pressure and develop appropriate lifestyle habits by providing personalized, optimized treatment guidance to individual patients based on medical evidence and encouraging awareness/behavior changes. The hypertension treatment application used in this study will automatically analyze blood pressure and lifestyle characteristics of individuals from data that includes blood-pressure monitoring using a smart blood pressure monitor and lifestyle habit logs. This data will be used to provide optimal treatment guidance (advice on diet, exercise, sleep, etc., and information to encourage behavior improvements).


 <Source>
*1: The Guidelines for the Management of Hypertension 2019 [JSH2019], The Japanese Society of Hypertension (2019) https://www.jpnsh.jp/guideline.html




Hypertension is the biggest risk factor for serious cardiovascular diseases such as stroke, myocardial infarction, and cardiac failure. Although thoroughgoing anti hypertensive measures ensures to control these diseases, the control rate for hypertension in Japan is only about 30% at present. Reducing salt and alcohol intake, proper weight control, and exercise are very important in treating hypertension. However, these measures are difficult to maintain on a continual basis. Digital Therapeutics is the world’s first app to treat hypertension that provides full support for improving lifestyle habits directly lowering blood pressure by encouraging behavioral changes based on cognitive behavioral therapy. With its elaborate treatment program and the innovative application of new information technology, Digital Therapeutics assesses individual patients, and ensures an interactive information exchange between patients and physicians based on appropriate guidance with proven scientific evidence and patient behavior records. I hope to see this app serving as the first step toward realizing a “self-cure of hypertension“ by closely monitoring the daily lives of individuals to help them improve their lifestyle habits.



The spread of “Hypertension Digital Therapeutics“ as a treatment covered by health insurance will lead to preventing the progression of hypertension and inhibiting cardiovascular diseases. After this clinical trial, we aim to obtain regulatory approval and health insurance coverage. "Digital Therapeutics" can provide appropriate medical guidance to patients at home and outside the hospital, making it possible to provide highquality personalized medical care to people of working age who find it difficult to make frequent visits to clinics, as well as people in remote areas. I feel certain that the increased use of "Digital Therapeutics," a new therapeutic approach using digital technology, will create new value in medical care for hypertension and contribute to reducing future medical costs.






CureApp, Inc. is a MedTech start-up company that performs research and development and produces software as a medical device for disease treatments based on advanced software technology and medical evidence. CureApp pursues the research and development of "Digital Therapeutics“, a disease treatment app, to establish a new form of medical service in Japan with a concept of “an app that cures diseases”.
"Digital Therapeutics" draws on a daily therapeutic process tailored to each patient to provide new therapeutic effects through analysis and guidance based on medical knowledge and evidence. Encouraging patients to improve their habits through raising their awareness and changing their behavior may also contribute to disease improvement. We clearly differentiate "Digital Therapeutics" app from the other unapproved healthcare applications as we aim to demonstrate the therapeutic effect of the "Digital Therapeutics" app in clinical studies, etc., obtain regulatory approval, and commercialize them as medical devices in the future. CureApp led the way in launching clinical studies of therapeutic application in Japan, and Our first therapeutic application, ”Therapeutic Application for Nicotine Addiction," has completed clinical trials and is currently under application for regulatory approval. Development and clinical research on therapeutic applications for hypertension and NASH (non-alcoholic steatohepatitis) have also launched. We plan to leverage our U.S. subsidiary, which we founded last year, serve as a base of operations for broadly rolling out such "digital health solutions from Japan“ based on the model developed in Japan.

At present, the development status of "Digital Therapeutics" is as follows.
  • Nicotine Addiction Digital Therapeutics (clinical trial completed in December 2018): Joint development with Department of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine. The clinical trial was completed at the end of 2018. It is currently under application for regulatory approval.
  • Non-alcoholic Steatohepatitis (NASH) Digital Therapeutics: Joint development with The University of Tokyo Hospital. The clinical research was started in October 2016; a multicenter clinical study began in April 2018.
  • Hypertension Digital Therapeutics: Joint development with Division of Cardiovascular Medicine, Department of Medicine, Jichi MedicalUniversity School of Medicine. The clinical trial starts in December 2019.




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