Neurofit "Dementia Solution Launching Next Month... Targeting Clinical Trials with 'Imaging CRO'"

As treatments that remove the fundamental causative substances of Alzheimer's dementia are emerging one after another, Neurofit, a domestic brain disease imaging artificial intelligence (AI) solution company, will launch AquaAD, an end-to-end service related to dementia treatment covering everything from clinical trials to treatment and prognosis management, in the global market next month.

Bin Jun-gil, CEO of Neurofit
Photo by Lee Chun-hee

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At the 2024 BIO International Convention (BIO USA) held in San Diego, California, USA, on the 4th (local time), we met with Bin Jungil, CEO of Neurofit, who said, "AquaAD is an end-to-end service that allows you to see all information related to dementia treatment at a glance," adding, "Neurofit's analysis technology, which can analyze both positron emission tomography (PET) and magnetic resonance imaging (MRI), is consolidated in this service."

Dementia requires various diagnostic tests during the confirmation and treatment process. Alzheimer's dementia occurs when proteins such as amyloid beta and tau tangle in the brain, damaging brain cells. The levels of these proteins are evaluated through positron emission tomography (PET) and magnetic resonance imaging (MRI) scans to determine the onset of dementia and treatment prognosis. Recently approved domestic treatment, Leqembi, is prescribed to patients confirmed to have amyloid accumulation in the brain through PET scans. Furthermore, the market is expected to grow due to the need for monitoring side effects. Treatments like Leqembi dislodge amyloid attached to blood vessels, which can cause amyloid-related imaging abnormalities (ARIA) such as intracerebral hemorrhage and brain edema, necessitating regular brain MRI scans during treatment to check for abnormalities.

Neurofit's AquaAD provides services for all related imaging, including amyloid positivity determination through PET, ARIA occurrence measurement through MRI, and amyloid reduction confirmation to verify treatment effectiveness. It is scheduled for a global launch at the Alzheimer's Association International Conference (AAIC) held next month in Philadelphia, USA. CEO Bin said, "We expect treatment prescriptions to begin in earnest from the second half of this year," adding, "We also anticipate obtaining approval from the U.S. Food and Drug Administration (FDA) within next year."

Bin Jun-gil, CEO of Neurofit, is introducing the company's dementia treatment analysis solution, AquaAD.
[Photo by Lee Chun-hee]

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At this year's BIO USA, Neurofit focused on introducing its 'Imaging Clinical Research Organization (CRO)' service globally. A CRO is an organization that designs, consults, monitors, and manages data for clinical trials on behalf of pharmaceutical companies during new drug development. CEO Bin explained, "An imaging CRO is a CRO specializing in image analysis," adding, "Previously, image analysis was done manually, which posed risks of human error and took a long time. However, during the clinical trial of Aribio's oral dementia treatment AR1001 currently underway, we have improved analysis quality while reducing the analysis time from one week to just one day."

Neurofit's imaging CRO service has attracted significant interest at BIO USA, with big pharma companies developing dementia treatments requesting meetings first. CEO Bin said, "After attending for three consecutive years and receiving substantial support from the Korean Pavilion, we set up our first booth," adding, "We scheduled about 20 meetings in advance and held additional meetings on-site." Neurofit's strength in the imaging CRO business is its 'Asia-based' foundation. For Asian-based pharmaceutical companies, it is generally considered necessary to include a certain proportion of Caucasians in clinical trials to ensure racial diversity. However, CEO Bin emphasized, "Since head shapes differ by race, brain structures inevitably vary as well," adding, "Major competitors are American and European companies that do not properly analyze Asian data, but we have collected abundant data on Westerners as well, targeting both Asian and advanced markets."

He also reported significant achievements through cooperation with Samjin Pharmaceutical and Aribio. CEO Bin said, "Regarding the AR1001 clinical trial, we are participating as an imaging CRO," adding, "We provide analyses related to indicators such as how much efficacy appears and how long the drug should be taken, which Aribio wants to obtain during the clinical process." He continued, "With Samjin Pharmaceutical, we are collaborating not only on treatments but also on diagnostic technologies and the entire industry," adding, "We are also developing electronic medicine aiming for commercialization in 2026, and we expect sales synergy related to this as well."

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