GCCL advance Alzheimer’s R&D with new MAO-B biomarker assay for NeuroBiogen

GCCL (Global Clinical Central Lab) said Thursday it established an assay for monoamine oxidase B (MAO-B), a central nervous system (CNS) disease biomarker, under a contract research agreement with NeuroBiogen.

MAO-B is an enzyme that breaks down monoamines such as dopamine and is known to regulate neurotransmitter levels. MAO-B inhibitors are currently used to treat Parkinson's disease.

NeuroBiogen’s phase 2a clinical trial -- funded by GCCL -- is a randomized, double-blind, placebo-controlled, and dose-exploratory study designed to evaluate the efficacy and safety of KDS2010 in patients with Alzheimer’s disease and mild Alzheimer’s disease dementia at the mild cognitive impairment stage.
Tisolagiline (project name: KDS2010), being developed by NeuroBiogen, is a reversible and selective MAO-B inhibitor designed to overcome the limitations of existing drugs in maintaining long-term therapeutic efficacy. For this trial, GCCL has developed and validated an assay to detect MAO-B in clinical samples.

According to GCCL, the assay has been optimized to reliably isolate MAO-B from platelet-rich plasma (PRP) in blood and to accurately measure its activity. Compared to existing methods, the new assay can clearly differentiate MAO-B levels between Alzheimer’s patients and individuals without the disease. It is also expected to be used in the future to evaluate MAO-B inhibitor effectiveness and to support diagnosis and research of CNS diseases.

“Previous assays have been limited in studying MAO-B inhibitors due to low measurable activity levels or the difficulty in distinguishing activity differences between healthy individuals and Alzheimer’s patients,” said Dr. Hyun Jae-wook, who leads the research team at GCCL. “With this new assay, we can identify elevated MAO-B activity in Alzheimer’s patients and determine the degree of significant inhibition achieved through the drug’s mechanism.”

The company believes the MAO-B assay identified in Alzheimer’s patients could be extended to other CNS diseases such as Parkinson’s, depression, and dementia.

“Tisolagiline is an innovative drug candidate with structural differentiation that targets MAO-B and is expected to offer a new paradigm for Alzheimer’s treatment,” said Kim Sang-wook, CEO of NeuroBiogen. “Our collaboration with GCCL in this clinical development process has strengthened the scientific foundation of our core pipeline, tisolagiline, through high-precision, biomarker-based assays.”

GCCL CEO Cho Kwan-goo added that the development of the MAO-B assay was the result of fully leveraging the company’s clinical analytics platform and expertise. “We will continue to actively support drug development companies in designing precise and efficient clinical strategies based on advanced biomarker analysis technologies,” he said.

*Links: GCCL, NeuroBiogen advance Alzheimer’s R&D with new MAO-B biomarker assay (Korea biomedical Review, https://www.koreabiomed.com/news/articleView.html?idxno=28029)