Aculys Pharma and Four H Initiate Research Collaboration using Wearable Devices to Study Sleep Disorders in Japan

• Digital biomarkers will assess patients’ sleep and daytime activity
• Research could result in a more multifaceted and higher-quality approach to evaluating treatment efficacy
• Sleep disorders represent an unmet medical need in Japan, including serious co-morbidities, quality of life, and social issues

TOKYO–(BUSINESS WIRE)–Aculys Pharma, Inc. (�Aculys”), a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, and Four H, Inc. (“Four H”), a Japan- based company specializing in health technology, announced an exploratory research collaboration using wearable devices to help patients with narcolepsy and excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS).

In its quest to establish a new pharmaceutical model, Aculys is promoting DX (digital transformation) in clinical trials and medicine. In this collaborative exploratory study to be launched with Four H, Aculys will collect trial participants’ subjective assessments of their sleep as well as data on their sleep, activities, and heart rate acquired from wearable devices to be worn each night during the clinical trial period. These data will be analyzed in conjunction with other data to be obtained in the clinical trial with the goal of identifying sleep-related digital biomarkers.

This exploratory research program will be characterized by the following three points:

1. Objective understanding of narcolepsy, OSAS, and its characteristics (sleep condition, daytime sleepiness, etc.)
2. Analysis using AI and other methods to collate the subjective assessment by patients and objective assessment obtained by the wearable device
3. Development of appropriate and reliable digital biomarkers for future clinical trials and clinical setting

Through the above approach, which is unprecedented in conventional clinical trials for sleep-related diseases, the following outcomes are expected: objective understanding of patients’ sleep status, analysis of daytime sleepiness patterns, extraction of sleep characteristics, and daytime activity data through comparison with people without symptoms, and detection of predictive signs of the onset of daytime sleepiness.

Sleep disorders are difficult to objectively identify, and largely rely on the memory and self-reporting of patients themselves, causing a range of challenges in diagnoses and appropriate treatment.

This exploratory research will allow a further accurate understanding of each patient’s sleep and lifestyle patterns, which had been difficult to measure previously. Over the long term, we collectively plan to build a comprehensive sleep ecosystem for patients, including: digital biomarkers which can be used to predict health risks; personalized data to improve patient quality of life and productivity; and quality disease management programs that patients can utilize at home.

About Sleep Disorders* in Japan

The impact of sleep-related disorders on Japanese society is enormous. Research shows that presenteeism (decreased productivity at work due to health issues) and absenteeism (absence or sick leave due to health issues) is causing an economic loss of about 3% of Japanese GDP, equivalent to about 15 trillion yen¹. Japanese people also sleep less than people in other countries due to lack of understanding about the importance of sleep. The Japanese government’s “National Health Promotion Movement in the Twenty-First Century (Health Japan 21)” includes sleep as one of the key themes in attempting to raise awareness^2-3.

Sleep disorders are also factors that interfere with proper sleep and daytime sleepiness. It has been reported that delays in appropriate medical intervention for sleep disorders and complications associated with sleep disorders (e.g., cardiovascular diseases, depression) increase overall costs to society including medical care expenditure^4-7. In order to improve the patient’s quality of life, prognosis, productivity, and other factors, it is necessary to detect sleep disorders accurately and provide appropriate medical care at an early stage.

*General term for sleep-related illnesses, including insomnia, sleep-related breathing disorders (e.g., OSAS), and central hypersomnia (e.g., narcolepsy)

About Four H, Inc.

Health infrastructure is a must-have in order to maintain the healthy lives of people so that they can fulfill active lives in pursuit of happiness. Our mission is to foster the health industry that supports good health. By building an infrastructure for people to stay healthy, and by working together with medical institutions, pharmaceutical companies, medical device manufacturers, and health-related companies, we aim to create a society where people can strive to maintain good health, even before they become ill.

Company name: Four H, Inc.

Address: LINK SQUARE SHINJUKU 16th floor, 5-27-5 Sendagaya Shibuya-ku Tokyo, Japan

Representative Director: Atsushi Koshio

Established: June 2020

URL: https://www.four-h.co.jp

About Aculys Pharma, Inc.

Aculys Pharma is a clinical stage biopharmaceutical company focused on the commercialization of neurology innovations for patients in Japan. Aculys was formed in 2021 as a catalyst to neurology innovation access. We are committed to shortening the drug lag in Japan by developing and commercializing novel CNS treatments; applying blockchain and AI technologies to increase speed to market; and providing services to improve medical care for patients, their families, healthcare professionals, and society.

Company name: Aculys Pharma, Inc.

Address: The ARGYLE Aoyama, 2-14-4 Kitaaoyama, Minato-ku, Tokyo, Japan

Representative: Kazunari Tsunaba

Established: January 2021

URL: https://aculys.com

References:

1. Hafner M et al. Why Sleep Matters-The Economic Costs of Insufficient Sleep. Cambridge, UK: RAND Europe; 2016
2. OECD (2009), Society at a Glance 2009: OECD Social Indicators, OECD Publishing, Paris.
3. Ministry of Health, Labour and Welfare, 2019 research report on health and nutrition of Japanese nationals
4. Lyons MM, et al. Global burden of sleep-disordered breathing and its implications. Respirology 2020 Jul;25(7):690-702.
5. Skaer TL, Sclar DA. Economic implications of sleep disorders. Pharmacoeconomics 2010;28(11):1015–23.
6. Leger D, Bayon V, Laaban JP, et al. Impact of sleep apnea on economics. Sleep Med Rev 2012;16: 455–62.
7. Flores NM, Villa KF, Black J, Chervin RD, Witt EA. The humanistic and economic burden of narcolepsy. J Clin Sleep

The information on pharmaceuticals contained in this release is for the purpose of disclosing our management information, and is not intended as a promotion or advertisement for the pharmaceuticals concerned.

Contacts

Aculys Pharma Communications Office (c/o Cosmo Public Relations Corporation)

aculys_pr@cosmopr.co.jp

Mika Shirai, Aculys Pharma

mshirai@aculys.com??

Public Affairs Department, Four H

info@four-h.co.jp