The central nervous system controls how we move, think, and feel. Naturally, it can be severely impacted by neurological disorders. Diseases and disorders of the central nervous system are also known as neurological or neurodegenerative disorders and include stroke, Alzheimer’s, Parkinson’s, and autism spectrum disorder. Although no cures are available, biomarkers are used in the drug development of CNS diseases. This blog post will look at what biomarkers are and which ones are used in CNS drug development.
What Are Biomarkers?
Biomarkers, or biological markers, is an umbrella term that includes a wide range of measurable characteristics that indicate conditions, processes, or states within the body. A biomarker is a medical sign, not a reported symptom, that can provide evidence of disease, treatments, and other internal processes. The WHO defines biomarkers as ‘almost any measurement reflecting an interaction between a biological system and an environmental agent.’ These markers can be biological, chemical, or physical.
As mentioned, biomarkers include nearly anything that can be measured within the body. This includes blood pressure, BMI, heart rate, and other factors that can be measured at a routine doctor visit, but also protein levels in bones, tumor molecules, and so much more.
They can be classified based on their primary application and include the following categories:
- Pharmacodynamic / Response
- Susceptibility / Risk
These markers are crucial for drug development because scientists use them during the clinical phase to measure the effects of drugs and therapeutic treatments on a patient.
What Biomarkers Are Used For CNS Drug Development?
The brain and spinal cord comprise the central nervous system (CNS), and diseases that develop within them are known as neurological disorders. CNS disorders include Alzheimer’s disease, Multiple sclerosis (MS), and Parkinson’s disease, and can occur due to several factors, including congenital disabilities, infections, and age-related degeneration.
CNS diseases often result in debilitating and life-changing effects; Thus, there is an urgent need for therapeutic agents that positively affect the treatment and management of central nervous system diseases and disorders. However, CNS drug development is costly and comes with many challenges, often reducing novel drug success rates. On the positive side, specific CNS biomarkers are essential for CNS drug development and are more frequently used in therapeutic developments.
Some CNS biomarkers commonly used in drug development for neurological diseases include electroencephalographic (EEG) biomarkers, exosomes and cerebrospinal fluid (CSF), just two of the immunological biomarkers, and lipids. Although lipids are not new in drug development, they are being used as biomarkers for brain diseases. Lipids and lipoproteins play a crucial role in the functions and structure of the brain, including impulse conduction, insulation, neurogenesis, signaling, and more. Due to the high concentration of lipids in the central nervous system, using them as biomarkers provides a wealth of information about brain function, cell signals, and metabolism. It is believed that changes in lipid metabolism are a key factor in neurodegenerative diseases1.
Synexa: Biomarkers and Drug Development
Synexa Life Sciences has provided state-of-the-art biomarker and bioanalytical services to biopharma customers for nearly 20 years. We provide and validate biomarker assays that can be used with lipids to develop therapeutic targets for those involved in central nervous system drug development.
Contact us for more information on how biomarkers are used in CNS drug development or to learn more about our services.
- Wenk, M., (2005) The emerging field of lipidomics https://pubmed.ncbi.nlm.nih.gov/16052242/
- Mandal, A. (2019) What is a Biomarker? https://www.news-medical.net/health/What-is-a-Biomarker.aspx
- Strimbu, K., and Tavel, J. (2010) What are Biomarkers? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078627/
- IPCCS. (1993) Biomarkers and Risk Assessment: Concepts and Principles https://apps.who.int/iris/bitstream/handle/10665/39037/9241571551-eng.pdf
- Manzanares, J. (2022) Comprehensive Pharmacology https://www.sciencedirect.com/science/article/pii/B9780128204726000608
- Yash, B., Tarasenko, M., and Light, G., (2019) Handbook of Behavioural Neuroscience https://www.sciencedirect.com/science/article/abs/pii/B9780128031612000126