[의학신문·일간보사=김영주 기자]Aribio (CEO Jae-Jun Jeong) announced on the 14th that it would start the US FDA global phase 3 clinical trial of AR1001, a multi-mechanical Alzheimer’s disease treatment, in earnest by inviting Professor David Greeley of the Department of Neurology at Washington Medical University, a world authority in dementia clinical medicine, on the 18th.
Aribio recently successfully completed a phase 2 clinical trial meeting with the US FDA for AR1001, a dementia treatment, and is planning to apply for global phase 3 approval to the US FDA in July, complete drug manufacturing in August, and administer to patients in December.
AR1001 is an oral dementia treatment with multiple mechanisms of action, such as improving blood flow by expanding cerebral blood vessels, inhibiting neuronal cell death, activating long-term memory forming proteins and brain cell proliferation proteins, and removing toxic proteins in the brain. In the U.S. phase 2 clinical trial, the effect of suppressing dementia progression and improving cognitive function was successfully proven.
Professor David Greeley, who will visit Korea for the first time at Aribio’s invitation, is a key researcher in the phase 2 and 3 clinical trials of AR1001, which is currently being developed by Aribio as the first oral dementia treatment. He will stay in Korea from the 18th to the 23rd and hold a phase 3 clinical meeting with the AR1001 researchers to discuss the study design and protocol (protocol).
In addition, we will hold an Alzheimer’s Disease Expert Meeting with professors and specialists from the Korean Neuroscience Association to share global information on dementia treatment development, such as discussions on dementia clinical trials in Korea and the United States, the current status of global Alzheimer’s disease treatment development, and future new drug prospects. Is expected. Korean institutions related to dementia, such as the Yonsei University Metabolic Dementia Center, and pharmaceutical research institutes are also planned to be visited.
Professor Greeley said, “As a result of oral administration in the second phase of clinical trial, AR1001 is relatively safe and has superior blood flow and brain barrier permeability compared to other therapeutic agents (PDE5 inhibitors). Not only the effect, but also other potential effects are expected.”