SEONGNAM, South Korea--(BUSINESS WIRE)--Today AriBio Co., Ltd. announced the completion of the end of phase 2 meeting (EOP2) with the United States Food and Drug Administration (FDA), Division of Neurology 1. The EOP2 meeting, which occurred April 28th on Thursday morning Eastern Standard Time (EST), included several individuals from different departments within the FDA, including non-clinical, clinical, biostatistics, and Dr. Billy Dunn, the Director from the Office of Neuroscience. “AriBio is very appreciative of the time and attention the FDA provided in preparation for and during this EOP2 meeting,” said James Rock, CEO of AriBio USA, INC.
“Importantly, AriBio was able to discuss the Phase 3 program including the target Alzheimer’s population and thoughts on acceptable endpoints for the study. We now have a clear understanding of FDA current thinking on drug development for the Alzheimer’s population, and the endpoints for a Phase 3 program,” stated Dr. Matthew Choung, CEO of AriBio Co., Ltd.
Attendees on behalf of AriBio included clinical, non-clinical, medical, statistics and regulatory experts with a deep understanding of drug development for the Alzheimer’s population. At this juncture of development, AriBio will move forward with protocol development and wait for the meeting minutes from the FDA to ensure alignment with our clinical program. AriBio recognizes some additional safety studies will be required in renal and hepatic impaired subjects and some additional non-clinical studies will also be necessary to complete a regulatory submission to seek FDA approval.
David Greeley MD FAAN, Associate Professor from the University of Washington and a practicing neurologist in the greater Spokane, Washington area, was the Primary Investigator in AriBio’s Double-Blind, Randomized and Placebo-Controlled Phase 2 Study to Evaluate Efficacy and Safety of 52-Week Treatment in Patients with Mild to Moderate Alzheimer's disease. Dr. Greeley commented that the meeting was efficient and extremely well run with the FDA providing very important feedback on trial design.
About AR1001
AR1001 is a first-in-class oral drug with novel polypharmacological mechanisms for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity. AR1001 also has demonstrated notable effects against amyloid plaques and tau proteins via autophagy activation. The results of a Double-Blind, Randomized and Placebo-Controlled Study to Evaluate Efficacy and Safety of 52-Week Treatment in Patients with Mild to Moderate Alzheimer's disease was reported at 14th Conference of Clinical Trials on Alzheimer’s Disease (CTAD) that was held in Boston, USA, from November 9-12, 2021. The study provided encouraging evidence of the tolerability and activity of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments, subject to ongoing clinical testing.
About AriBio Co., Ltd.
AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with a focus on the development of new drugs for neurodegenerative disease. AR1001 is the lead candidate for Alzheimer's disease, which is scheduled to enter a multinational Phase 3 study in the United States, Europe, and Korea in 2022. AriBio is also developing several other drug candidates for the treatment of neurodegenerative diseases.
