Pharma Focus Asia
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AriBio Granted EMA Authorization for Phase 3 Clinical Trial of AR1001 in Alzheimer’s Treatment (POLARIS-AD)

Monday, April 29, 2024

AriBio Co., Ltd. (AriBio) has received approval from the European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01), a phase 3 clinical trial targeting early Alzheimer’s disease. This approval aligns with similar authorizations from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the trial.

EMA's decision, finalized on April 24th, grants approval for the trial to proceed in several member states including the Czech Republic, Denmark, France, Germany, Italy, Spain, and The Netherlands. The trial aims to enroll 1,150 participants across 200 sites worldwide.

POLARIS-AD is a significant trial evaluating the efficacy and safety of AR1001 (Mirodenafil) in treating early Alzheimer’s disease with confirmed amyloid pathology. It employs primary and secondary endpoints accepted by FDA and EMA, including the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) and several others.

AriBio, expressed satisfaction with the trial's expansion into additional European countries, viewing it as a milestone in AR1001's registration program. He emphasized the company's dedication to efficiently expand the trial into these regions to meet the demand for alternative Alzheimer’s treatments. The global nature of the trial enhances accessibility to the treatment if its efficacy and safety are demonstrated.

AR1001 is a phosphodiesterase-5 (PDE5) inhibitor under investigation as an oral agent for Alzheimer’s disease treatment. Pre-clinical studies suggest it may offer neuroprotective effects by inhibiting neuron apoptosis and restoring synaptic plasticity, indicating potential disease-modifying effects.

The trial, AR1001-ADP3-US01 (NCT05531526), is a phase 3 double-blind, randomized, placebo-controlled, multi-center trial evaluating AR1001 in early Alzheimer’s disease patients. More information about the trial is available on



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