SEONGNAM, South Korea--(BUSINESS WIRE)--AriBio Co., Ltd., a clinical-stage biopharmaceutical company based in South Korea, announced today, 21st of January 2021, the completion of last patient last visit in a Phase 2 study of AR1001. AR1001 is a first-in-class, orally dosed investigational drug for mild to moderate Alzheimer’s disease. A total of 210 patients were enrolled, and 171 (81.4%) subjects completed 6-month dosing in the study.
“We are pleased to report the achievement of this critical milestone, and AriBio is looking forward to announcing the topline results by the end of Q1’2021. Despite the challenges presented by the COVID-19 pandemic, we were able to complete dosing and follow-up assessments in this trial. We are extremely grateful to our study participants, their family members and healthcare professionals who worked tirelessly to complete the primary assessments of the study,” said James Rock, Senior Vice President of Clinical Operations.
AriBio offered an optional 6-month extension phase of the study, where patients could either stay on active drug or be randomized to the low or high dose of active medication. “Notably, over 80% of the patients opted to participate in the extension study, signaling an excellent safety and tolerability profile of AR1001 as well as the overall patients’ positive reaction to the drug. We are encouraged to quickly generate the topline results and to move forward with a global phase 3 program,” said Dr. Matthew Choung, Chief Executive Officer.
AriBio is the first company from South Korea to successfully complete a Phase 2 study for Alzheimer’s disease in the United States. The company aims to initiate another Phase 2 study for Dementia with Lewy Bodies in 2021 and a Phase 3 program for Alzheimer’s disease in 2022.
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.
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. 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 the development of new drugs for neurodegenerative and infectious diseases. AR2001 is the lead candidate for sepsis and COVID-19 treatment, which is scheduled to enter a Phase 1 study in the United States in 2021.