According to a recent article in Business Wire, it is estimated that five million people in the United States over the age of sixty-five are coping with Alzheimer’s at this moment. At the same time, there are about one million Americans living with Parkinson’s disease.
Scientific studies suggest that both diseases actually begin about twenty years before there is any evidence of symptoms.
It is for this reason that it is critical to be able to locate measurable substances to indicate the presence of a disease (biomarkers) or develop treatments for use around the time of the onset of a disease.
Neurodegenerative brain diseases include, among others, Parkinson’s disease, Alzheimer’s disease, and Lewy body dementia. Dementia is a condition that describes symptoms that interfere with a person’s daily activities such as loss of judgment, memory loss, and cognitive abilities.
The Phase 1 CST-2032 Clinical Trial
In response, CuraSen Therapeutics, a biotechnology company, is conducting a Phase 1 trial investigating its new therapy called CST-2032 in Belgium and New Zealand. This week CuraSen announced that Phase 1 trial participants (n70) have just received the first dosing of CST-2032. The therapy is being tested for the treatment of Alzheimer’s, Parkinson’s, and other neurodegenerative diseases.
CuraSen designs its drugs to activate specific receptors in the brain. This action compensates for the loss of glial and neuronal functions resulting from deterioration, aging, wear and tear, or injury.
The researchers used dosing levels of single and multiple ascending components. Biomarker assessments were used including autonomic testing to gauge how the nervous system controls heart rate, blood pressure, and sweating.
CST-2032 is a selective receptor modulator (SRM) that affects different tissues in various ways, often referred to as “tissue-selective” drugs.
It is a drug that targets critical receptors in limbic and cortical areas of the brain. CST-2032 targets receptors that have lost the ability to communicate nervous energy in the brains of people who have neurodegenerative diseases.
CuraSen’s studies are designed to measure the drug impact on symptoms of diseases such as memory, mood, arousal, cognition, metabolic health, and brain inflammation.
Restoring the Function of Cell Types
CST-2032 activates certain receptors in the brain, thus restoring normal function to the following cell types:
- Neurons – one of two main cell types (together with glial cells) in the central nervous system
- Astrocytes – a type of glial cell with many functions
- Microglia – search the brain tissue to protect the Central Nervous System from plaques, pathogens, damaged neurons, and other potential threats.
- Pericytes – situated along capillary walls; functions include the formation of blood vessels, maintaining the blood barrier, regulating the entry of immune cells to the central nervous system, and controlling brain blood flow.
CuraSen’s spokesman commented that developing a drug and moving it to a clinical trial in under two years is quite an accomplishment.
CuraSen’s CST-2032 approach uses different types of cells (heterocellular) and has the potential for improving cerebral function and integrity.
The company had conducted three earlier clinical trials using drugs that had already been established. The company attempted to establish clinical endpoints, biomarkers, and most effective dosing. The trials focused on the effect of the drug on brain function.
The measures used by the company included:
- Chemical biomarkers – molecules in the blood, tissues, or body fluids that are signs of normal or abnormal disease.
- Neuroimaging– the imaging of the anatomy and function of the CNS in disease and in health
- Autonomic testing
The last component will be the evaluation of patients after they have received CST-2032 therapy.
The company is anticipating a Phase 2 trial in 2021.