Detection of Succination as a Measure of Fumarate Ester Efficacy


Reference #: 01221

The University of South Carolina is offering licensing opportunities for a technology that facilitates the measurement of protein succination levels in body fluids/tissues.



Dimethylfumarate/Monomethylfumarate-containing drug formulations are increasingly prescribed in the US for the treatment of relapsing remitting multiple sclerosis (M.S). However, despite their clinical efficacy they are associated with side effects and an increased risk of developing progressive multifocal leukoencephalopathy (PML), a deadly brain infection. To date, the only way to monitor and assess a patient's risk of developing severe infections such as PML while receiving these drugs is to regularly monitor the lymphocyte count.


Invention Description:

The subject invention seeks to determine patient responses to the drugs by measuring the degree of modification of the proteins targets or protein succination levels in body fluids/tissues (especially blood). When in contact with novel proteins targets in the brain, dimethyl fumarate (Tecfidera) binds to and modifies proteins targets.


Potential Applications:

Dimethyl fumarate (Tecfidera) may be a better neuroprotective drug than other MS therapies, though it also poses the risk of developing PML; a deadly brain infection. Currently the only option for monitor the response to DMF/Tecfidera is monitoring patient white blood cell count at 3 month intervals. The direct measurement of protein succination, a product of the drug reactivity with protein cysteine residues would provide a more direct measurement of DMF efficacy and may provide a much better correlate/indicator of the patient risk of developing lymphopenia and/or PML. Furthermore, the quantification of protein succination may be an additional biomarker that should be monitored in a patient who had a low lymphocyte count and could help determine if DMF therapy should be halted.


Advantages and Benefits:

1.       Describes a specific chemical reaction of the drugs (Tecfidera/fumarate esters) with protein thiols to generate a stable protein modification

2.       Provides a much more accurate marker of the drug's direct influence on the immune system (or any protein in the body that it reacts with, even by monitoring urinary peptides containing it).

3.       May be a much stronger predictor of patient susceptibility to further infection while on the drug, rather than monitoring white blood cell counts alone.


Patent Information:
Title App Type Country Serial No. Patent No. File Date Issued Date Expire Date Patent Status
Detection of Fumarate Ester Derived Modification in a Test Sample PCT PCT PCT/US2018/046861   8/17/2018     Published
Detection of Fumarate Ester-Derived Modification in a Test Sample Nationalized PCT United States 16/639,678   2/17/2020     Published
For Information, Contact:
Technology Commercialization
University of South Carolina
Norma Frizzell
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