CureApp and Jichi Medical University Collaborate on a Hypertension Therapeutics App: Primary Endpoint Met in Phase III Clinical Trial in Japan

A major step toward realizing a groundbreaking new treatment method for hypertension — the first of its kind in Japan

TOKYO–(BUSINESS WIRE)–#CureApp–CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake; hereafter “the Company”) has completed a Japanese Phase III multicenter randomized controlled trial of their digital therapeutics (“DTx”) app to treat hypertension, which was jointly researched by a team led by Professor Kazuomi Kario at Jichi Medical University. Results of this study showed a statistically significant difference in average systolic blood pressure^*1 over a 24-hour period – the primary endpoint of this study, demonstrating a hypotensive effect. Moving forward, the Company will seek regulatory approval based on the results of this study.

Summary of the clinical trial and efficacy of the hypertension therapeutics app

Commencing in December 2019, this trial^*2 evaluated the efficacy and safety of the DTx app when used with patients with essential hypertension who had not received oral treatments using antihypertensive drugs. For this comparative study, subjects were divided into two groups. This included a control group that only applied lifestyle changes based on the Guidelines for the Management of Hypertension 2019 (hereafter, “the Guidelines”)^*3, and an intervention group using the DTx app in addition to the lifestyle changes proposed in the Guidelines.

As a result, the intervention group showed a statistically significant difference from the control group in the “deviation from the baseline in the average systolic blood pressure over a 24-hour period as measured by ambulatory blood pressure monitoring (ABPM)^*4 in the 12th week of the study” – the primary endpoint. This demonstrates that the DTx app had a marked effect in treating hypertension. The results from this study will be presented in detail at conferences and in papers at a later date to be notified separately.

The potential of therapeutics for hypertension

Hypertension is the highest risk factor for cerebral and cardiovascular diseases (stroke and heart disease). An estimated 100,000 people^*5 die of hypertension-induced cerebral and cardiovascular diseases every year. In Japan, hypertension is found in some 43 million people^*3, and medical costs associated with hypertension have ballooned to around 1.7 trillion yen^*6. Despite this, only around 10 million people^*7 are said to receive continuous treatment for hypertension, less than one-quarter of the total affected.

While lifestyle improvements are vital for treating hypertension, maintaining such changes is dependent on a patient’s values and motivation, their workplace and home environment, and other factors. This presents challenges for effective intervention by medical institutions. There is also a subset of patients that wish to avoid medication who struggle with reducing their blood pressure. In response to these issues, this DTx app automatically delivers treatment guidance personalized to the individual (optimal nutritional, exercise, and sleeping advice based on an IoT blood pressure monitor and lifestyle habit logs, and notifications prompting behavioral changes) directly to the patient. This form of treatment helps reduce hypertension without the use of medication by encouraging changes in mindset and behavior, and aiding patients in adopting appropriate lifestyle habits.

*1 Systolic blood pressure: High blood pressure measured in blood pressure measurements.

*2 Kario K. Nomura A. Satake K. et al. A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial. J Clin Hypertens. (Greenwich) 2020;22(9):1713-1722 https://doi.org/10.1111/jch.13993
*3 Guidelines for the Management of Hypertension 2019 [JSH2019]; The Japanese Society of Hypertension (2019) https://www.jpnsh.jp/guideline.html

*4 Ambulatory blood pressure monitoring (ABPM): Continuous blood pressure measurements taken at predetermined intervals over a 24 hour period during the course of one’s daily life. This helps determine variations in blood pressure (variation patterns over the course of a day). This is important due to the various factors which may alter one’s blood pressure.

*5 “Vital Statistics Summary”2019 Study (Ministry of Health, Labour and Welfare)

https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei19/dl/15_all.pdf
*6 “Medical Care Expenditure Summary” 2018 Study (Ministry of Health, Labour and Welfare)

https://www.mhlw.go.jp/toukei/saikin/hw/k-iryohi/18/index.html
*7 “Patient Study”2017 Study (Ministry of Health, Labour and Welfare)

https://www.mhlw.go.jp/toukei/saikin/hw/kanja/17/dl/05.pdf

Department of Cardiovascular Medicine, Jichi Medical University

Professor Kazuomi Kario

The fact that the world’s first hypertension therapeutics app was able to produce a hypotensive effect with relation to the average systolic blood pressure over a 24-hour period – a key evaluation item of this Phase III clinical study (trial) – represents a significant step forward for hypertension treatment. When treating hypertension, reducing the risk of serious complications through therapeutic intervention and reducing blood pressure at an early stage is vital. Treatment is based on reducing salt intake and maintaining a proper weight, getting sufficient exercise and sleep, and other lifestyle changes. The digital hypertension treatment that this DTx app provides through the use of an advanced bidirectional algorithm represents a new field for hypertension treatment, and is expected to play a pivotal role in providing medical care tailored to the individual, and in promoting drug-free treatments that do not rely on medications.

CureApp, Inc.

Kohta Satake, CEO and Practicing Doctor

We have expanded our focus to encompass algorithm development to provide personalized healthcare advice based on medical evidence. The more data provided by the patient, the more the advice given is specifically tailored to the patient’s condition. We view the popularization of digital therapeutics for hypertension as having the potential to alter hypertension treatments for the better, as well as greatly contribute to reducing medical care expenses. Following our nicotine dependency therapeutic app “CureApp SC”, which was the first app of its kind to be covered by insurance in Japan, we also look to receive regulatory approval and insurance coverage for our hypertension therapeutics app.

About CureApp, Inc.

CureApp, Inc. is a MedTech venture that conducts research and development into the creation of medical device programs which apply advanced software technology and medical evidence to treat illnesses, with the intent of manufacturing and distributing them. We are hard at work developing “digital therapeutics” – apps used to treat illnesses – in order to become the first in Japan to establish a new healthcare service centered on “creating new therapeutic effects through technology.” In August 2020, the nicotine dependency treatment app and CO checker, “CureApp SC,” became the first therapeutic app to receive regulatory approval in Japan, and prescriptions began as a treatment covered by insurance in December of the same year.

In addition to the hypertension therapeutic app, we are currently pursuing research and development into various other digital therapeutics apps. These include a nonalcoholic steatohepatitis (NASH) therapeutic app jointly developed and currently undergoing clinical trials with the University of Tokyo Hospital, joint research on an app with the National Hospital Organization Kurihama Medical and Addiction Center, and a patient support app for cancer patients being jointly developed with DAIICHI SANKYO COMPANY, LIMITED.

We also draw upon the knowledge accumulated through the development of these therapeutic apps for medical institutions to provide the “ascure Smoking Cessation Program” for corporations that have been implemented at over 200 companies, health insurance associations and local municipalities.

Moving forward, we will look to sequentially roll out this Japanese-developed digital therapeutics solution worldwide.

[CureApp, Inc. Company Profile]

Representative Director and CEO: Kohta Satake

Head office: Kodenma-Cho YS building 4F, 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan

Business description: Development of medical device programs, mobile health-related services

URL: http://cureapp.co.jp/

[Jichi Medical University Overview]

Name: Jichi Medical University

Representative: Director, Toshio Oishi

Address: 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan

URL: http://www.jichi.ac.jp/

Contacts

[Contact Details]

[For research inquiries]

Department of Cardiovascular Medicine, Jichi Medical University

Professor Kazuomi Kario

Ph: +81 285-58-7538 E-mail: [email protected]

[For inquiries regarding therapeutics apps]

CureApp, Inc.

PR Representative, Yuuki Mishima

Ph: +81 3-6231-0183 E-mail: [email protected]