AriBio Co., Ltd., a biotechnology company dedicated to leading the treatment of neurodegenerative diseases, announced that the National Medical Products Administration of China, along with the Center for Drug Evaluation (CDE), has approved an investigational new drug (IND) application to initiate the Phase 3 Polaris-AD trial of AR1001 for early Alzheimer's disease (AD) in China on May 11, 2024.

This Phase 3 clinical trial will recruit patients with early-stage Alzheimer's disease at as many as 20 clinical trial centers in China. Compared with other countries that are also recruiting patients, the eligibility criteria for patient enrollment in Chinese clinical trial centers are consistent. The main evaluation indicators include Clinical Dementia Rating Sum Scale (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13), Amsterdam Activities of Daily Living Questionnaire (A-iADL-s-QV) ), Geriatric Depression Scale (GDS), Mini-Mental Function Evaluation (MMSE), and changes in cerebrospinal fluid (CSF), imaging, and plasma biomarkers.

Eleven countries including the United States, South Korea, the United Kingdom, Germany, France, Spain, Italy, Denmark, the Netherlands, the Czech Republic, and China have officially approved POLARIS-AD IND and clinical trial applications. AriBio continues to deliver on its global commitment to address the urgent need for innovative therapies to treat Alzheimer's disease.

AriBio continues to expand its presence in the fight against Alzheimer's disease with the addition of China, a key player in the global pharmaceutical market, through AR1001's Phase 3 clinical development trial. The trial involved approximately 1,150 participants at more than 200 clinical sites in 11 countries.

AriBio CEO Dr. Jai Jun Choung expressed his joy at this milestone, saying, "We are delighted to receive IND approval for AR1001 in China! This significant achievement reflects AriBio's unwavering commitment to advancing globally New treatment for Alzheimer's disease. With IND approval in all target countries, including China, we are one step closer to bringing hope to millions of patients around the world."

AriBio is preparing to start this Phase 3 clinical trial in China in the third quarter of 2024. Dr. Choung reiterated AriBio's dedication to success, saying, "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 pride and responsibility. . We are grateful for the support and interest of every country participating in our clinical trials and remain steadfast in our pursuit of breakthrough treatments for Alzheimer's disease."

AR1001 is a phosphodiesterase-5 (PDE5) inhibitor being developed as an investigational oral drug for the treatment of Alzheimer's disease. Preclinical studies have confirmed that AR1001 has neuroprotective effects by inhibiting neuronal apoptosis and restoring synaptic plasticity, demonstrating multiple mechanisms of disease modulation that may improve the course of AD.

AR1001-ADP3-US01 ( NCT05531526 ) is a Phase 3 double-blind, randomized, placebo-controlled, multicenter trial evaluating the efficacy and safety of AR1001 in patients with early-stage Alzheimer's disease. For more information about clinical trials, visit ClinicalTrials.gov and the National Medical Products Administration website.

 

Source: businesswire.com

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