Role of Biomarkers in MS Research

A biomarker is a biological sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.

Currently, MRI scans are the only biomarker – or measurement – used in MS research. But MRIs cannot accurately measure if a treatment truly promotes myelin repair, which represents the next generation of MS treatments.

Biomarkers are Instrumental in Accelerating MS Treatments

A myelin repair biomarker would speed all phases of myelin medical research – in the lab, in drug development and clinical trials. And ideally, it would be faster and less invasive to patients.

It would provide information for many types of studies and trials:

• During in vitro studies (outside of a living organism, like in a petri dish)
• For ex vivo (patient fluid sample analysis)
• For in vivo experiments (on a whole living organism, like on an animal model)
• For clinical trials (on humans)

The optimum marker would indicate the biology which drives demyelination / remyelination in MS – i.e., tell us about what is going on with the cells in the brain.

MRF’s Biomarker Goal

MRF’s goal is to identify a biomarker that will:

1. Cut time by having a marker of repair that occurs quickly (days/weeks)
2. Reduce patient numbers by allowing better patient selection (e.g., find those at risk for low repair)
3. Be found in blood so that the procedural costs and “intrusiveness” will be minimal

Our hope is to develop biomarkers that will be relevant to each of the distinct types of MS and promote the development of drugs specific to each MS type:

• RRMS - Relapsing Remitting MS
  The most common disease course – is characterized by clearly defined attacks of new or increasing neurologic symptoms.
• PPMS - Primary Progressive MS
  With PPMS, neurologic functions get steadily worse in the beginning. There are no symptom flare-ups (also called relapses or attacks). And there is no recovery (remission).
• SPMS - Secondary Progressive MS
  SPMS follows an initial relapsing-remitting course. Some people who are diagnosed with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. SPMS can be further characterized as either active (with relapses and/or evidence of new MRI activity during a specified period of time) or not active, as well as with progression (evidence of disability accrual over time, with or without relapses or new MRI activity) or without progression
• Smoldering MS
  MS characterized by the presence of shouldering lesions, a specific type of lesion observed in people living with MS that is chronically active and grows slowly over many years.
• CIS - Clinically Isolated Syndrome
  A single exacerbation / episode that may represent the onset of MS or may represent an isolated episode that does not require ongoing treatment.