Fujirebio Holdings Inc., its wholly owned subsidiary Fujirebio Diagnostics Inc. and AriBio Co. Ltd announced that they have formed a strategic partnership to advance the development of biomarkers Alzheimer's disease and other neurodegenerative diseases. The agreement allows Fujirebio to access clinical samples and data collected in the ongoing Phase 3 study in Alzheimer's disease launched in December 2022 by AriBio.

AriBio completed in 2021 a Phase 2 study in patients with mild to moderate Alzheimer's disease of its lead compound AR1001, a PDE5 inhibitor with demonstrated preclinical efficacy in inhibiting apoptosis neurons, promote neurogenesis, increase neuroplasticity and stimulate autophagy activity to eliminate toxic proteins. The Phase 3 study in patients with early-stage Alzheimer's disease, called AR1001-ADP3-US01, has been initiated in the United States with plans to expand to other countries in 2023.

Fujirebio, a trusted partner for high-quality IVD testing solutions and a pioneer in the diagnosis of neurodegenerative diseases, is committed to accelerating the development of biomarkers to improve the diagnosis of Alzheimer's disease. Fujirebio was the first company to develop and commercialize cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease testing and the first to receive FDA clearance in 2022 for its Lumipulse® G β test -Amyloid Ratio (1-42/ 1-40). Fujirebio continues to advance in this area to provide fully automated blood tests for Alzheimer's disease and other neurological disorders.

«AriBio is committed to not only advancing treatment options for the benefit of Alzheimer's disease patients and their families, but also to improving diagnostic solutions and characterization of this devastating disease. This initial partnership with Fujirebio is the first of several other collaborations that we plan to launch in the coming years, as we expand our clinical programs into other areas of neurodegeneration. For us, Fujirebio is an ideal partner and this agreement reflects our commitment to make decisive progress in this field. We look forward to working closely with Fujirebio to improve the detection of Alzheimer's disease and other neurodegenerative diseases through their pioneering tests."

“ Fujirebio continues to be at the forefront of the industry in developing high-quality functional tests that improve clinicians' ability to detect and diagnose various neurodegenerative conditions. We are constantly seeking partnerships with companies and clinical experts around the world in order to develop new avenues for earlier treatments and new diagnostic tools for simpler and more complete neurodegenerative states,” said Monte Wiltse. , CEO of Fujirebio Diagnostics Inc.

About AR1001-ADP3-US01
AR1001-ADP3-US01 (NCT05531526) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with early-stage Alzheimer's disease. The purpose of the study is to evaluate, through various cognitive and functional assessments, the efficacy and safety of AR1001 in slowing the progression of Alzheimer's disease. 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 is dedicated to developing novel therapies for neurodegenerative diseases, including Alzheimer's disease. Aribio multiplies partnerships to accelerate the development of the best treatment options and record new advances in the medical field.

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

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Contacts
James Rock – AriBio
jimrock@aribiousa.com

Chris Dague – Fujirebio
chris.dague@fujirebio-us.com

 

Source:businesswire.com

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