AriBio Gets China's NMPA IND Approval for POLARIS-AD Alzheimer's Phase 3 Trial

AriBio Co., Ltd. (AriBio), a pioneering biotech firm focused on neurodegenerative disease treatments, has secured approval for their Investigational New Drug (IND) application from China's National Medical Products Administration (NMPA). This approval, granted on May 11, 2024, allows AriBio to initiate the Phase 3 Polaris-AD trial for AR1001 in early-stage Alzheimer's Disease (AD) patients in China.

The Phase 3 trial will take place across up to 20 clinical centers in China, maintaining consistent eligibility criteria with trials conducted in other countries. Key metrics for evaluation in the trial include the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), Amsterdam-Activities of Daily Living Questionnaire (A-iADL-S-QV), Geriatric Depression Scale (GDS), Mini-Mental State Examination (MMSE), and changes observed in cerebrospinal fluid (CSF), imaging, and plasma biomarkers.

AriBio's acceptance of the POLARIS-AD IND and associated clinical trial applications in 11 countries - including the United States, South Korea, the United Kingdom, Germany, France, Spain, Italy, Denmark, the Netherlands, the Czech Republic, and now China - highlights their commitment to innovative Alzheimer's therapies on a global scale.

China's inclusion, given its significant role in the global pharmaceutical market, enhances the impact of AriBio's Phase 3 trial development for AR1001. The trial aims to enroll around 1,150 participants across more than 200 clinical centers worldwide.

Dr. Jai Jun Choung, CEO of AriBio, expressed his enthusiasm regarding this development, describing the IND approval in China as a significant milestone. "Receiving IND approval in China is a major achievement, underscoring AriBio's dedication to advancing novel Alzheimer's treatments globally. With this approval, we are one step closer to providing hope to millions of patients."

AriBio is set to begin the Phase 3 clinical trial in China by the third quarter of 2024. Dr. Choung emphasized the company's commitment and responsibility as the first Korean biopharmaceutical firm to manage and conduct a global Phase 3 trial of this magnitude. "We are committed to our mission with pride and responsibility, and we appreciate the support from each country involved in our clinical trials. We continue our pursuit of groundbreaking Alzheimer's treatments," Dr. Choung added.

AR1001, the investigational drug in question, is a phosphodiesterase-5 (PDE5) inhibitor developed as an oral treatment for Alzheimer's Disease. Pre-clinical studies have demonstrated AR1001's neuroprotective effects, including inhibiting neuron apoptosis and restoring synaptic plasticity. The drug exhibits multiple mechanisms that can potentially modify the disease course of Alzheimer's Disease.

The AR1001-ADP3-US01 (POLARIS-AD) trial, registered under NCT05531526, is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial evaluating the efficacy and safety of AR1001 in early Alzheimer's Disease patients. Further details about this clinical trial are available on ClinicalTrials.gov.

AriBio Co., Ltd., based in South Korea with offices in the United States, focuses on developing novel therapies for neurodegenerative diseases, including Alzheimer's Disease.

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