The trial plans to enrol nearly 1,150 Alzheimer’s patients across more than 200 clinical centres in 11 countries. Credit: CGN089 / Shutterstock.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.