SEONGNAM-SI, South Korea–(BUSINESS WIRE)–AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China. The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease. The trial is using the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted primary endpoint Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as well as secondary endpoints including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), in addition to changes in Cerebrospinal fluid (CSF) and plasma biomarkers levels.
AriBio received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) this August in South Korea and submitted the Clinical Trial Application (CTA) to Center for Drug Evaluation under National Medicinal Products Administration (NMPA) this September in China with approvals expected by the end of 2023. With the adoption of scientific advice from the Committee for Medicinal Products for Human Use (CHMP) in Europe, AriBio plans to submit the CTA to EMA and MHRA by the end of 2023 with approvals expected in the first-half of 2024.
“The Polaris-AD global expansion plan not only helps facilitate recruitment and enrollment into the trial, but also allows the collection of efficacy and safety data as needed to justify new drug applications in these regions. This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies. AriBio is well positioned and adequately financed to execute on this global expansion”, stated Matthew Choung, Chairman and Chief Executive Officer (CEO) of AriBio.
AR1001 is a PDE5 inhibitor being developed as an investigational oral agent 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 has also demonstrated robust reduction of hyperphosphorylated tau proteins in pre-clinical models and in a Phase 2 trial.
AR1001-ADP3-US01 (NCT05531526) is Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. The study aims to assess the efficacy and safety 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.
AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. The company continues to expand its partnerships to accelerate the development of meaningful treatment options for neurodegenerative diseases.