The global trial is set to randomise 1,150 participants across 200 sites. Credit: Lighthunter/Shutterstock.com.

The European Medicines Agency (EMA) has granted authorisation for AriBio’s Phase III clinical trial, POLARIS-AD (AR1001-ADP3-US01), of AR1001 for treating early Alzheimer’s disease.

This follows previous approvals by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), marking a significant milestone in the development of AriBio’s investigational oral agent AR1001.

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The EMA’s final decision allows the trial to proceed in several member states, including the Czech Republic, Denmark, France, Germany, Italy, Spain, and the Netherlands.

This global trial is expected to randomise 1,150 participants across 200 sites, testing the efficacy and safety of AR1001, a phosphodiesterase-5 (PDE5) inhibitor.

POLARIS-AD is a double-blind, placebo-controlled, multi-centre registration trial. It utilises the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as its primary endpoint, a measure accepted by both the FDA and EMA.

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Secondary endpoints include Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Geriatric Depression Scale (GDS), Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Mini-Mental Status Examination (MMSE), and changes in plasma and cerebral spinal fluid (CSF) biomarkers.

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AriBio chief clinical officer James Rock said: “This acceptance represents the fourth region that will be actively screening and enrolling participants starting from Q2’2024. The company has committed significant resources to expeditiously and efficiently expand the footprint of the Phase III programme into these regions.

“This, coupled with a strong interest in alternative treatment options for patients with AD, has fueled global interest in AR1001. Operating this study globally makes the asset extremely attractive for worldwide access should efficacy and safety be demonstrated.”

AR1001 is being developed as a potential oral therapy for Alzheimer’s. It has demonstrated neuroprotective effects in pre-clinical studies.

These effects include inhibiting neuron apoptosis and restoring synaptic plasticity, which may potentially slow the progression of the disease.

These findings suggest that AR1001 may have disease-modifying effects that could potentially alter the course of Alzheimer’s disease.