Provision of a General-Purpose Clinical Trial System and a Machine-Learning-Based Automated Analysis System

「SUSMED, Inc., a Japanese company that develops therapeutic apps and clinical trial support systems, announced on 16 September that a drug tested in a clinical trial using a system based on the company’s blockchain technology had obtained manufacturing and marketing approval in Japan.」

「It has been reported that the domestic Phase III clinical trial of the histamine H3 receptor antagonist/inverse agonist Pitolisant in patients with narcolepsy and the domestic Phase III clinical trial of Pitolisant in patients with excessive daytime sleepiness remaining in association with obstructive sleep apnea syndrome, both conducted by アキュリスファーマ株式会社 using the company's blockchain-enabled clinical trial management system, SUSMED SourceDataSync®, produced favorable analysis results, including achievement of their primary endpoints. SUSMED SourceDataSync® is also being used in the investigator-initiated clinical trial for myalgic encephalomyelitis/chronic fatigue syndrome conducted by National Center of Neurology and Psychiatry, the specified clinical study of a therapeutic app targeting premenstrual syndrome and premenstrual dysphoric disorder launched as part of the joint development with あすか製薬株式会社, and the company-sponsored clinical trial conducted by Heartseed株式会社 targeting severe heart failure caused by ischemic heart disease and dilated cardiomyopathy.」

「The company's clinical trial system is also being used in the investigator-initiated clinical trial for myalgic encephalomyelitis/chronic fatigue syndrome conducted by National Center of Neurology and Psychiatry, and in the specified clinical study of a therapeutic app targeting premenstrual syndrome and premenstrual dysphoric disorder launched as part of the joint development with あすか製薬株式会社.」

「In addition, construction of the integrated venous disease registry system using SUSMED SourceDataSync®, which had been developed with National University Corporation Tohoku University, has been completed, and the system has begun to be offered to companies.」

「In the DTx platform business, the company uses its blockchain-enabled clinical trial management system, SUSMED SourceDataSync®, in アキュリスファーマ株式会社's domestic Phase III clinical trial of the histamine H3 receptor antagonist/inverse agonist Pitolisant in patients with narcolepsy and its domestic Phase III clinical trial of Pitolisant in patients with excessive daytime sleepiness remaining in association with obstructive sleep apnea syndrome.」

「In the DTx platform business, the company uses its blockchain-enabled clinical trial management system, SUSMED SourceDataSync®, in アキュリスファーマ株式会社's domestic Phase III clinical trial of the histamine H3 receptor antagonist/inverse agonist Pitolisant in patients with narcolepsy and its domestic Phase III clinical trial of Pitolisant in patients with excessive daytime sleepiness remaining in association with obstructive sleep apnea syndrome. SUSMED SourceDataSync® is also being used in the specified clinical study of the tinnitus treatment app launched as part of the joint development with 杏林製薬株式会社.」

「The specified clinical study of the tinnitus treatment app launched in the DTx product business is also using SUSMED SourceDataSync®.」

「As of the date of filing this document, 2 company-sponsored clinical trials are being conducted at the company.」

「In addition, the domestic Phase III clinical trial of the histamine H3 receptor antagonist/inverse agonist Pitolisant in patients with excessive daytime sleepiness remaining in association with obstructive sleep apnea syndrome has commenced at the company as the second company-sponsored clinical trial using blockchain technology.」

「A Phase III clinical trial in Japan of Pitolisant, a histamine H3 receptor antagonist/inverse agonist, using the company's blockchain technology has begun at Aculys Pharma, Inc.」

「In the DTx platform business, preparations are under way to conduct what will be the world's first company-sponsored clinical trial using blockchain technology, pursuant to an agreement with Aculys Pharma, Inc. concerning the conduct of the clinical trial.」

「In June 2022, the company entered into an outsourcing agreement with Aculys Pharma, Inc. for conducting what was the world's first company-sponsored clinical trial using blockchain technology.」

「Regarding the provision of the general-purpose clinical trial system, operations have begun in a clinical trial at Tokyo Medical and Dental University, whose project was selected for an AMED program, and the company has entered into a joint research agreement with Tohoku University. Regarding the provision of the automated machine-learning analysis system, the company has also begun joint research with Kyushu University, whose project was selected for an AMED program.」

「Regarding the provision of the general-purpose clinical trial system, operations have begun in a clinical trial at Tokyo Medical and Dental University, whose project was selected by the Japan Agency for Medical Research and Development (AMED), although its contribution to revenue remains limited.」