Professor Greeley, who led ‘AR1001’ Phase 2 and 3, visits Korea
Applied for phase 3 clinical trial with FDA next month
Year-end dosing start goal
Aribio announced on the 14th that it would invite David Greeley, a professor of neurology at Washington Medical University (pictured), a world-renowned dementia clinician.
Professor Greeley will visit Korea from the 18th to the 23rd. She plans to discuss the design and plan (protocol) of phase 3 clinical trials with the researchers of the oral Alzheimer’s treatment ‘AR1001’. Professor Greeley explained that he is a key researcher who will lead the phase 3 clinical trial of AR1001, which is being developed by Aribio.
He plans to meet with professors and specialists from the Korean Neuroscience Association to discuss dementia clinical trials in the United States and share information on the current status of global Alzheimer’s dementia treatment development. He also visits research institutes such as the Metabolic Dementia Center at Yonsei University and research institutes of pharmaceutical companies.
Professor Greeley is considered a world authority in the field of dementia clinical. He participated in 60 major clinical trials related to the treatment and prevention of dementia. biogen(192.16 -2.70%) He participated in the entire clinical research process of ‘Aducanumab’ and is conducting safety and efficacy evaluations of Eli Lilly’s ‘Donanemap’.
Aribio plans to speed up the global phase 3 clinical trial of AR1001 with Professor Greeley’s visit to Korea as an opportunity. Aribio recently completed phase 2 clinical trial of AR1001. It plans to file a global phase 3 approval application with the US Food and Drug Administration (FDA) next month. The goal is to finish manufacturing the finished drug in August and start administering the drug to patients in December.
AR1001 is an oral dementia treatment with multiple mechanisms of action, such as improving blood flow through cerebral vasodilation, inhibiting neuronal cell death, activating long-term memory-forming proteins and brain cell proliferation proteins, and removing toxic proteins in the brain. It is explained that it has proven the effect of suppressing dementia progression and improving cognitive function in the second phase of clinical trials in the United States.
Professor Greeley said, “The results of phase 2 clinical trials show that AR1001 has superior blood flow improvement and cerebrovascular barrier permeability compared to other therapeutic agents such as PDE5 inhibitors. I look forward to it,” he said.
Reporter Lee Seon-ah suna@hankyung.com
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