Topline results expected early 2021
SEONGNAM, South Korea--(BUSINESS WIRE)--AriBio, a clinical-stage biopharmaceutical company based in South Korea, announced today, June 17th 2020, the completion of enrollment in a Phase 2 study of AR1001, a first in class, orally dosed investigational drug for mild to moderate Alzheimer’s disease. A total of 210 patients are enrolled in the study, and the company is expecting to announce the topline results by early 2021.
“The completion of enrollment is a significant milestone for AriBio, and the company is extremely thankful for the combined efforts of our researchers, partners and the patient community. Advancing safe, effective and meaningful therapies for this devastating disease is our top priority at AriBio, and we look forward to presenting this data in the future,” said James Rock, Senior Vice President of Clinical Operations.
“Patients participating in the study are showing extremely low drop-out rates despite the COVID-19 pandemic and the safety profile of the drug has been encouraging,” said Matthew Choung, Chairman and CEO.
AriBio is the first company from South Korea to fully enroll a Phase 2 study for Alzheimer’s disease in the United States. The company aims to initiate another Phase 2 study for Mixed Dementia in 2021.
AR1001 is a first in class oral therapy 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 positive effects against amyloid plaques and tau proteins.
AR1001-ADP2-US01 (NCT03625622) is A Double-Blind, Randomized and Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients with Mild to Moderate Alzheimer's disease. The study aims to assess the safety and efficacy of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments. Last patient visit is expected to occur by the end of 2020. The details of the clinical trial are available at ClinicalTrials.gov.
About AriBio Co., Ltd.
AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with a focus on neurodegenerative and infectious diseases. AR1003 is the lead candidate for sepsis and COVID-19, which is preparing to enter a Phase 1 study in the United States by early 2021.