AriBio's POLARIS-AD Phase 3 Alzheimer's Trial Gets MHRA Green Light

AriBio Co., Ltd., a biopharmaceutical enterprise based in South Korea with a presence in the United States, has been granted approval to proceed with a Phase 3 clinical trial for POLARIS-AD, which is aimed at treating early Alzheimer’s disease. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has given AriBio the green light to initiate the trial, which is expected to commence before the end of the first quarter of 2024.

The POLARIS-AD trial is designed as a double-blind, randomized, and placebo-controlled study that will span 52 weeks. It will assess the effectiveness and safety of AR1001, also known as Mirodenafil, in patients diagnosed with the early stages of Alzheimer’s. The trial will utilize the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as its primary endpoint, a measure recognized by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additional secondary endpoints will include a range of cognitive and functional assessments, as well as biomarker evaluations in cerebral spinal fluid and plasma. Participants in the trial will have confirmed amyloid presence, a key factor in Alzheimer’s disease.

James Rock, AriBio’s Chief Clinical Officer, has expressed that the acceptance of the POLARIS-AD study in the UK is a significant milestone in the advancement of AR1001. He also mentioned that AriBio plans to expand the trial to other regions with favorable regulatory and commercial conditions for innovative Alzheimer’s treatments.

AR1001 is an investigational oral medication that functions as a phosphodiesterase-5 (PDE5) inhibitor. Pre-clinical research has indicated that AR1001 has neuroprotective properties, potentially reducing neuronal cell death and enhancing synaptic plasticity, which are crucial for improving the Alzheimer’s disease trajectory.

Furthermore, AR1001-ADP3-US01 (NCT05531526) is a Phase 3 clinical trial that seeks to evaluate the efficacy and safety of AR1001 in mitigating the progression of Alzheimer’s disease over a 52-week period. The trial’s details can be accessed on ClinicalTrials.gov.

AriBio is dedicated to pioneering new treatments for neurodegenerative disorders, with a particular focus on Alzheimer’s disease. The company’s commitment to advancing AR1001 underscores its dedication to improving patient outcomes and contributing to the field of neurology.