AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Strategic Partnership to Advance Biomarker Development for Alzheimer�s Disease and Neurodegeneration

SAN DIEGO & TOKYO & MALVERN, Pa.–(BUSINESS WIRE)–#AR1001–Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced a strategic partnership to advance the development of biomarkers for Alzheimer�s disease and other neurodegenerative conditions. The agreement provides Fujirebio access to clinical samples and data collected as part of the ongoing Phase 3 Alzheimer’s disease study launched by AriBio in Dec. 2022.

AriBio completed a Phase 2 study in 2021 in mild to moderate Alzheimer’s disease patients with their lead compound AR1001, a PDE5 inhibitor with preclinical efficacy shown to inhibit neuron apoptosis, promote neurogenesis, increase neuroplasticity, and stimulate autophagy activity to remove toxic proteins. The Phase 3 study in patients with early Alzheimer’s disease, AR1001-ADP3-US01, has been launched in the United States and plans to expand to other countries in 2023.

Fujirebio, a trusted partner for high-quality IVD testing solutions and a pioneer in neurodegenerative disease diagnostics is committed to the advancement of biomarkers to improve diagnosis of Alzheimer’s disease. Fujirebio was the first company to develop and market cerebrospinal fluid (CSF) biomarkers for Alzheimer’s disease testing and the first to receive FDA authorization in 2022 for its Lumipulse® G ?-Amyloid Ratio (1-42/ 1-40) test. Fujirebio continues to make advances in the field to provide fully automated blood-based tests for Alzheimer’s disease and other neurological disorders.

“AriBio is committed to advancing not just the treatment options for patients with Alzheimer’s disease and their families, but also the development of better diagnostics and improved characterization of this devastating disease. This initial partnership with Fujirebio is the first of several we plan to launch in the next few years as we expand our clinical programs into other areas of neurodegeneration. Fujirebio is an ideal partner for us and reflects our commitment to advancements in this space. We look forward to working closely with Fujirebio to improve the detection of Alzheimer’s disease and other neurodegenerative diseases with their pioneering assays,” commented James Rock, President of AriBio Co., Ltd US Office.

“Fujirebio continues to lead the industry in the development of high quality, functional tests to improve clinicians’ ability to detect and diagnose a variety of neurodegenerative conditions. We continue to partner with organizations and clinical experts across the world to develop new pathways for earlier, easier, and more complete neurodegenerative diagnostic tools,” stated Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. 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. The company continues to expand its partnerships to accelerate best-in-class treatment options and further advancements in the field of medicine.

About Fujirebio

Fujirebio Diagnostics, Inc., a wholly owned subsidiary of H.U. Group Holdings, Inc. and Fujirebio Holdings, Inc., is a premier diagnostics company and the industry leader in cancer biomarker tests. Fujirebio Diagnostics specializes in the contract development and manufacturing for the diagnostics industry leaders and market development of novel in-vitro diagnostic products for the management of human disease states. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio.com. H.U. Group Holdings, Inc. (formerly known as Miraca Holdings Inc.) is a listed company on the Tokyo Stock Exchange – TYO: 4544.

Contacts

James Rock – AriBio

jimrock@aribiousa.com

Chris Dague – Fujirebio

chris.dague@fujirebio-us.com