Aribio Accelerates Development of Pre-Dementia Treatment 'AR1004'

Aribio is set to accelerate the development of 'AR1004', an oral treatment for mild cognitive impairment (MCI), the pre-dementia stage, in addition to its multi-mechanism oral Alzheimer's disease therapy 'AR1001'.

Aribio
Photo by Lee Chunhee

Aribio announced on the 18th that it recently received approval from the Ministry of Food and Drug Safety for a Phase 2 clinical trial plan (IND) for AR1004, a treatment for MCI, in South Korea.

AR1004 is part of Aribio's pipeline of multi-mechanism drugs targeting degenerative brain diseases, specifically for MCI. MCI, or mild cognitive impairment, refers to a pre-dementia stage where cognitive function and memory are objectively impaired, but daily living remains possible.

Aribio explained that a research team led by Dr. Ko Younghun at the Korea Institute of Oriental Medicine and Professor Seo Jinsu's team at the Department of Brain Science at Daegu Gyeongbuk Institute of Science and Technology (DGIST) observed that the natural substance-based composition of AR1004 showed a genotype-specific protective effect for apolipoprotein (Apo)E ε4, a risk factor for Alzheimer's disease, and demonstrated the ability to remove 'amyloid beta (Aβ)', a toxic protein in the brain.

Accordingly, as part of its strategy to develop a multi-mechanism and safe natural product-based dementia treatment, Aribio began joint development in 2021 and, in May last year, acquired the related technology from the Korea Institute of Oriental Medicine and DGIST. Since then, focusing on MCI treatment, the company has actively pursued research and commercialization, and in preclinical studies, has identified efficacy and scientific mechanisms such as inhibition of neuronal cell death and anti-neuroinflammatory effects.

This domestic Phase 2 clinical trial will evaluate the safety and efficacy of AR1004 in 144 MCI patients over 24 weeks, using a randomized, double-blind, placebo-controlled, parallel design. The clinical trial drug will be produced at the National Institute for Korean Medicine Development's herbal medicine manufacturing center (GMP), developed as a tablet formulation with minimal size, even though the granule formulation contains a high amount of excipients.

Jaejun Jung, CEO of Aribio, is giving a lecture on "The Future of K-Bio Dementia Treatments" at the "Good Brain 2023 Conference" held last month at the Westin Chosun Hotel in Jung-gu, Seoul. Photo by Hyunmin Kim kimhyun81@

Jaejun Jung, CEO of Aribio, stated, "We have already secured major clinical trial sites such as Kyunghee University Korean Medicine Hospital at Gangdong, Wonkwang University Korean Medicine Hospital, and Daejeon University Daejeon Korean Medicine Hospital, so we expect the first patient dosing could begin as early as this December." He added, "Since AR1004 is based on a natural substance with a long track record of safety, it is expected to demonstrate clear characteristics and advantages in MCI treatment, which requires long-term medication."

In addition to AR1004, Aribio's pipeline includes AR1001, which is currently undergoing global Phase 3 clinical trials, as well as 'AR1002' for Tau pathology Alzheimer's disease and Rett syndrome, 'AR1003', a combination therapy for mild-to-moderate Alzheimer's disease, and 'AR1005' for Lewy body dementia.

This content was produced with the assistance of AI translation services.