AriBio Receives IND Approval from China’s NMPA for POLARIS-AD, a Phase 3 Trial for the Treatment of Early Alzheimer’s Disease

SEONGNAM-SI, South Korea--(BUSINESS WIRE)--AriBio Co., Ltd. (AriBio), a biotech company dedicated to pioneering treatments for neurodegenerative diseases, announces approval of the Investigational New Drug (IND) application by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the initiation of the Phase 3 Polaris-AD trial in China of AR1001 in early Alzheimer’s Disease (AD) on May 11^th, 2024.

The Phase 3 clinical trial will enroll early AD patients at up to 20 clinical trial centers in China with consistent eligibility criteria compared to other countries that are also enrolling patients. Key evaluation indicators include 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), as well as changes in cerebrospinal fluid (CSF), imaging, and plasma biomarkers.

Following the successful acceptance of the POLARIS-AD IND and clinical trial applications in 11 countries, including the United States, Korea, United Kingdom, Germany, France, Spain, Italy, Denmark, Netherlands, the Czech Republic, and now China, AriBio continues to demonstrate its global commitment to addressing the urgent need for innovative therapies in the treatment of Alzheimer's disease.

With the inclusion of China, a significant player in the global pharmaceutical market, in the Phase 3 clinical trial development of AR1001, AriBio continues to expand its reach and impact in the fight against Alzheimer's disease. The trial targets an estimated 1,150 participants enrolled across over 200 clinical centers in 11 countries.

Dr. Jai Jun Choung, CEO of AriBio, expressed his enthusiasm about this milestone, stating, “We are thrilled to receive the IND approval for AR1001 in China, a major achievement that exemplifies AriBio's unwavering dedication to advancing novel treatments for Alzheimer's disease on a global scale. With IND approval in all targeted countries, including China, we are one step closer to offering hope to millions of patients worldwide.”

Looking ahead, AriBio is poised to commence the Phase 3 clinical trial in China in Q3 2024. Dr. Choung reiterated AriBio's dedication to success, stating, “As the first Korean biopharmaceutical company to directly manage and conduct a global Phase 3 clinical trial of this scale, we are committed to achieving our mission with a sense of pride and responsibility. We are grateful for the support and attention from each country participating in our clinical trial and remain steadfast in our pursuit of groundbreaking treatments for Alzheimer's disease.”

For more information about AriBio and its innovative pipeline of therapies for neurodegenerative diseases, please visit www.aribio.com.

About AR1001

AR1001 is a phosphodiesterase-5 (PDE5) inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity, demonstrating multiple mechanisms of action for disease modifying effects that may ameliorate the course of AD.

About AR1001-ADP3-US01 (POLARIS-AD)

AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial evaluating the efficacy and safety of AR1001 in patients with early Alzheimer’s disease. The details of the clinical trial are available at ClinicalTrials.gov.

About AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease.

Forward-Looking Statements:

This press release contains forward-looking statements that are based on current expectations and beliefs and are subject to several risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. AriBio undertakes no obligation to update any forward-looking statement.