MHRA Issues Notice of Acceptance for POLARIS-AD, a Phase 3 Early Alzheimer's Disease Trial Sponsored by AriBio Co., Ltd.

AriBio Co., Ltd. (AriBio) receives Notice of Acceptance for POLARIS-AD, a Phase 3 early Alzheimer's disease clinical trial from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK). The MHRA completed their review on the 21 of February and confirmed a favorable ethical opinion, the Company expects to initiate the clinical trial before the end of Q1'2024 in the UK.

POLARIS-AD is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (Mirodenafil) 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 cerebral spinal fluid (CSF) and plasma biomarkers. All early Alzheimer's disease participants enrolled and will have confirmation of amyloid.

"Acceptance of the POLARIS-AD clinical study in the UK is another achievement in the development of AR1001. This acceptance represents the third region that will be actively screening and enrolling participants in Q1'2024. As stated previously, AriBio will continue to expand the study into other regions where the regulatory and commercial markets are favorable for novel Alzheimer's disease treatments," stated James Rock, AriBio Chief Clinical Officer.

About AR1001

AR1001 is a phosphodiesterase-5 (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 demonstrating multiple mechanisms of action that may ameliorate the course of AD.

About AR1001-ADP3-US01

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.

About AriBio

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.