바이오스펙테이터

by Jongwon Jang

Clinical Trial for the Approval of Digital Therapeutics for ‘Visual Disorders upon Brain Damage’ will be Completed in 2020

Nunaps started into the first domestic clinical trial for the approval of digital therapeutics and succeeded in inviting an investment of 5 billion KRW for ‘Series A’. The investment will accelerate the development and clinical application of ‘digital therapeutics for visual disorders appearing after brain damage’, together with excavating subsequent pipelines.

Nunaps announced on the 3rd of this month that the company completed the invitation to invest a total of 5 billion KRW from CompanyK Partners, the KTB Network, and K2 Investment. The subsequent investment succeeded the seed funding from CompanyK Partners and Ntels in December 2017.

Nunaps is a start-up founded in November 2017 by President Kang dong-wha, Professor of Neurology at Ulsan Medical College and Asan Medical Center and in charge of an R&D Project dedicated to the development of digital therapeutics. Under the specified mission, ‘New Hope and Value for Those Suffering from Brain Disorders’, the company is identifying disease-specific biomarkers and developing digital therapeutics targeting the new biomarkers capable of fulfilling unmet needs in clinics.

President Kang dong-wha explained, “… a lot of patients are suffering from visual disorders caused by brain damage. Until now, no treatments have been available for the visual disorders. Therefore, the company was founded two years ago to find pertinent treatments and therapeutics applicable to clinics. Therapeutics in ‘digital format’ were naturally developed from efforts to give new hope to patients…”.

Digital therapeutics are based on software programs, such as AI, apps, games, VR, and ChatBot and are capable of curing, preventing, and controlling diseases or disorders. They can be released into the market upon completion of strict verification of the therapeutic efficacies and approval/permission of the regulating agencies, just like medical supplies. By following first-generation therapeutics, synthetic compounds, second-generation therapeutics, and biologics (such as antigens, proteins, and cells), digital therapeutics are classified as third-generation therapeutics and are being spotlighted for their growing potential, combined with advancements in AI and digital equipment becoming more familiar in our ordinary daily lives.

Currently, specialists and professionals in diverse disciplines, including engineering, cognitive psychology, mathematics, games and artificial intelligence, as well as medical specialists in neurology, are participating in the company, as is COO Hyun-Wook Nah(formerly a professor in the Department of Neurology in the Medical College of Dong-A University) and the head of the research laboratory, Hana Kim (formerly a clinical lecturer on dementia in the Department of Neurology of Asan Medical Center), centering around President Kang dong-wha.

In particular, Neunaps acquired approval last June from the Ministry of Food and Drug Safety for a corroborative clinical trial of digital therapeutics, called the ‘Nunap Vision’, for patients suffering from visual disorders from brain damage. It is the first domestic clinical trial for digital therapeutics approved by the Ministry of Food and Drug Safety.

Nunap Vision is an independent software medical device (SaMD) for HMD capable of curing visual disorders due to brain damage (disorders in the field of vision whereby the vision becomes narrower by damage to the visual center despite no damage to the eyes and optic nerves) for which no alternative pertinent treatments are available. The effect of improving the visual field was identified through explorative clinical trials conducted twice. Currently, multicenter clinical trials (in Asan Medical Center, Samsung Medical Center, and Seoul National University Hospital in Bundang) are in progress to demonstrate the software’s superiority by employing a double-blind approach, randomization, and corroborative clinical trials, culminating in an official report to be issued at the end of 2020.

Through the investment, Nunaps intends for the development of subsequent pipelines for a variety of brain diseases and is planning to become a company of digital therapeutic platforms.

President Kang dong-wha stated, “… it is important to conduct patient-centered research and development for the practical application in clinics…”, “… thus, patients will have opportunities to participate in the process of research and development and experience products therefrom with pertinent authority for the development of optimal, customized products…”.