AriBio and Fujirebio Announce Milestone in Alzheimer’s Biomarker Development

Fujirebio Holdings Inc., along with its subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd., have announced a significant milestone in their strategic collaboration aimed at advancing biomarker development for Alzheimer’s disease (AD) and other neurodegenerative disorders. This milestone grants Fujirebio access to clinical samples and data from the ongoing Phase 3 Alzheimer’s disease study known as POLARIS-AD.

The POLARIS-AD study intends to enroll up to 1150 participants with early-stage Alzheimer’s disease, utilizing AriBio’s AR1001, a PDE5 inhibitor. AR1001 has shown promise in preventing neuron death, encouraging new neuron growth, enhancing neuroplasticity, and promoting the clearance of toxic proteins through autophagy. The Phase 3 study has now broadened its scope to include regions such as South Korea, Europe, the United Kingdom, and China.

Fujirebio, a reputable and long-standing provider of high-quality in vitro diagnostic (IVD) testing solutions, has been at the forefront of neurodegenerative disease diagnostics for over 25 years. The company was the first to receive FDA approval for an IVD test specifically for Alzheimer’s disease in May 2022. Fujirebio’s commitment to the advancement of Alzheimer’s diagnostics through the development and commercialization of innovative biomarkers remains unwavering.

James Rock, Chief Commercial Officer of AriBio, emphasized the company’s dedication to enhancing biomarker development within the Alzheimer’s disease sector. The goal is to offer precise and valuable diagnostic tools for healthcare providers, patients, and their families. Early detection and prompt treatment initiation are critical for improving patient outcomes. The discovery and refinement of new biomarkers will not only facilitate disease detection but also aid in tracking disease progression and treatment efficacy.

The AR1001-ADP3-US01 study (NCT05531526) is a Phase 3, double-blind, randomized, placebo-controlled, multi-center trial designed to evaluate the efficacy and safety of AR1001 over a 52-week period in participants with early Alzheimer’s disease. The study aims to determine the effectiveness of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. Detailed information about the clinical trial can be found on ClinicalTrials.gov.

AriBio Co., Ltd., a biopharmaceutical company based in South Korea with additional offices in the United States, specializes in developing new therapies for neurodegenerative diseases, including Alzheimer’s disease. The company continues to expand its partnerships to accelerate the development of first-in-class treatment options and advancements in neurodegeneration research.

Fujirebio, part of H.U. Group Holdings Inc., is a global leader in the field of IVD testing. With over 50 years of experience in developing and commercializing reliable IVD products, Fujirebio was the pioneer in creating and marketing cerebrospinal fluid (CSF) biomarkers under the Innogenetics brand. The company remains unique in offering a comprehensive array of both manual and fully automated neurodegenerative disease assays. Fujirebio consistently collaborates with global organizations and clinical experts to develop new, more effective diagnostic tools for early and complete detection of neurodegenerative diseases.