China’s National Medical Products Administration (NMPA) has approved AriBio’s investigational new drug (IND) application to begin a Phase III clinical trial of AR1001 for early Alzheimer’s disease (AD).

The Polaris-AD trial will enrol patients at up to 20 trial sites in China, keeping the same eligibility criteria as other countries participating in the trial.

The double-blind, placebo-controlled study is designed to assess the efficacy and safety of AR1001, an oral phosphodiesterase-5 (PDE5) inhibitor, in patients with early AD.

Key assessment indicators for the trial include the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), and the Amsterdam-Activities of Daily Living Questionnaire (A-iADL-S-QV).

Additional measures such as the Geriatric Depression Scale (GDS), Mini-Mental State Examination (MMSE), and changes in cerebrospinal fluid (CSF), imaging and plasma biomarkers will also be used to gauge the product’s impact.

The Polaris-AD IND and trial applications have now been accepted in China, the US, the UK, Germany, France, South Korea, Italy, Denmark, the Netherlands, Spain and the Czech Republic.

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The trial aims to enrol an estimated 1,150 participants across more than 200 clinical centres in these countries.

AriBio CEO Dr Jai Jun Choung said: “With IND approval in all targeted countries, including China, we are one step closer to offering hope to millions of patients worldwide.

“As the first Korean biopharmaceutical company to directly manage and conduct a global Phase III clinical trial of this scale, we are committed to achieving our mission with a sense of pride and responsibility.”

AriBio is set to begin the Polaris-AD trial in China in the third quarter of this year.

In pre-clinical studies, AR1001 showed neuroprotective effects such as hindering neuron apoptosis and restoring synaptic plasticity, suggesting it may alter the course of Alzheimer’s disease through multiple mechanisms of action.