Development and Validation of MAO-B-Based Analytical Method
Through Neurobiogen Clinical Trial Project Collaboration
On June 25, clinical trial sample analysis institution GCCL announced that it has established an analytical method for MAO-B (monoamine oxidase B), a central nervous system (CNS) disease biomarker, through a clinical trial contract with Neurobiogen.
MAO-B is an enzyme that breaks down monoamines such as dopamine. It is known to regulate the levels of neurotransmitters. Currently, MAO-B inhibitors are used as treatments for Parkinson's disease. In particular, MAO-B is also known to be closely associated with Alzheimer's disease and is being utilized in various studies.
The clinical trial project supported by GCCL for Neurobiogen is a "randomized, double-blind, placebo-controlled, dose-finding phase 2a clinical trial to evaluate the efficacy and safety of KDS2010 in patients with mild cognitive impairment-stage Alzheimer's disease and mild Alzheimer's disease dementia." Tisolagiline (project name KDS2010), which is under development by Neurobiogen, is a reversible and selective MAO-B inhibitor that overcomes the limitations of existing drugs in maintaining therapeutic effects during long-term administration. For this clinical trial, GCCL has developed and validated an analytical method to detect MAO-B in clinical samples.
According to GCCL, this analytical method is optimized to stably isolate MAO-B from PRP (platelet-rich plasma) in blood and to precisely measure its activity. Compared to existing methods, it can clearly distinguish the difference in MAO-B levels between Alzheimer's patients and healthy individuals. Therefore, it is expected to be highly useful in evaluating the effects of MAO-B inhibitors and in the diagnosis and research of CNS diseases in the future.
According to the research team led by Dr. Hyeon-Uk Jeon at GCCL, including senior researcher Kim Minyoung, "Existing analytical methods had limitations in MAO-B inhibitor research because the measured MAO-B activity levels were low or it was difficult to distinguish the difference in activity between healthy individuals and Alzheimer's patients." The team added, "With the establishment of this new method, we have confirmed high MAO-B activity levels in Alzheimer's patients, making it possible to distinguish the significant degree of inhibition by the inhibitory mechanism." They further emphasized the technical distinction, stating, "The MAO-B analytical method confirmed in Alzheimer's patients is expected to be fully expandable to research on other CNS diseases such as Parkinson's disease, depression, and dementia."
Kim Sangwook, CEO of Neurobiogen, stated, "Tisolagiline is an innovative drug candidate with structural differentiation targeting MAO-B, and we expect it to present a new paradigm for Alzheimer's disease treatment." He added, "The collaboration with GCCL during this clinical development process has provided an opportunity to further refine the scientific foundation of our core pipeline, Tisolagiline, through high-precision biomarker-based analysis."
Jo Kwangoo, CEO of GCCL, said, "The development of this MAO-B analytical method is the result of mobilizing all of GCCL's clinical analysis platforms and expertise, and we are very pleased to participate as an analytical partner in Neurobiogen's innovative drug development process." He continued, "We will continue to actively support new drug development companies in establishing precise and efficient clinical strategies based on advanced biomarker analysis technologies."
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