SAN DIEGO, CA / TOKYO, Japan / MALVERN, PA — Fujirebio Holdings Inc., its subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. have announced the successful completion of a prospective sample acquisition, marking a significant milestone in their strategic partnership to advance biomarker development for Alzheimer’s disease and other neurodegenerative conditions. The achievement is tied to the POLARIS-AD Phase 3 clinical trial, which is investigating early Alzheimer’s disease.
The POLARIS-AD trial has enrolled over 1,150 participants globally, exceeding its enrollment targets. The study’s innovative design features an extensive biobank of plasma and cerebral spinal fluid samples collected both at baseline and after 52 weeks of treatment. This comprehensive dataset is further strengthened by a one-year extension phase, adding valuable longitudinal samples to the repository. The resulting biobank is among the largest of its kind, providing deep insights into this population and paving the way for critical advancements in diagnostic research.
Fujirebio Diagnostics, Inc., a leader in neurodegenerative disease diagnostics, continues its role at the forefront of Alzheimer’s biomarker development. Known for pioneering the first FDA-authorized in vitro diagnostic test for Alzheimer’s in 2022, Fujirebio brings 25 years of expertise in the development and commercialization of novel neurodegenerative biomarkers. The plasma samples obtained as part of the POLARIS-AD trial are instrumental in Fujirebio’s clinical performance evaluations of blood-based biomarkers aimed at detecting amyloid pathology, a hallmark feature of Alzheimer’s disease.
Commenting on this milestone, James Rock, Chief Commercial Officer of AriBio, recognized the critical role patient involvement has played in the study’s progress. “We can’t thank the patients, family members, and the Alzheimer’s community enough for such overwhelming support for this trial. AriBio will continue to conduct research and help expand biomarker development in this space with other committed parties. There is still tremendous need for understanding disease progress and patient responses to treatment. We hope these samples can be utilized to move us closer to answering these important questions,” Rock stated.
The collaboration between Fujirebio and AriBio represents a significant step forward in the understanding and treatment of Alzheimer’s disease. By leveraging an expansive biobank and advanced biomarker development capabilities, the partnership aims to address critical gaps in diagnosing and monitoring neurodegenerative conditions.
This achievement signals a promising future for Alzheimer’s research. The data derived from the POLARIS-AD trial not only advances the understanding of disease pathology but also strengthens the scientific foundation for innovative diagnostic tools. With continued efforts, this partnership could help transform how Alzheimer’s disease is understood, diagnosed, and treated, offering hope to millions affected by the disorder worldwide.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.