Trials Sponsored by: Sanofi

Tolebrutinib’s Phase II Study Results Summary:

In completed phase II study, 130 participants with relapsing remitting MS took one of 4 doses of tolebrutinib for 12 weeks either before or after taking placebo for 4 weeks.

Compared to the placebo period, treatment with the highest dose of tolebrutinib (same as used in current clinical trials) resulted in 85% to 89% relative reduction in new MS brain lesions.

The most frequently reported side effects in the phase II clinical trial were headaches, and flu-like symptoms.

How does Tolebrutinib work?

Tolebrutinib is experimental (not yet approved by health authorities) and administered orally, once daily, as a coated tablet. It inhibits an enzyme called “Bruton’s tyrosine kinase (BTK)”, reducing the activation of B cells, which are immune cells that affects the nerves in the brain and spinal cord contributing to MS. Tolebrutinib also penetrates the brain and spinal cord and may inhibit immune cells in the brain called microglia, which have been shown to play a role in MS disability progression. This mechanism of action may help strop relapses, stop the formation of new brain lesions and may stop progression of disability. Tolebrutinib is still under investigation for the treatment of MS.

 

Explore the role of immune cells inside the brain, how that may be increasingly important in the future of multiple sclerosis science and treatment.

As we learn more about MS, it is becoming clear that there are pathways inside the brain that are important for understanding the full spectrum of multiple sclerosis. This video explores the role of immune cells inside the brain, including B cells and microglia, and their pathways of cell activation, that may be increasingly important in the future of multiple sclerosis science and treatment.

Terms you need to know:

CNS: The central nervous system is represented by brain and spinal cord

B cells : A type of white blood cell that makes antibodies. These antibodies trap specific invading viruses and bacteria helping body to finish fighting most infections. B-cells also produce other substances with important role in the body immune response and inflammation.

Microglia: Microglia are specialized population of cells that reside in the brain and spinal cord. They remove damaged neurons and infections and are important for maintaining the health of the CNS.

Enzyme: An enzyme is a substance produced by the body to assist in breaking down chemicals.

Immune pathways involving cells compartmentalized in the CNS: Defense pathways which involve different type of cells which reside in the brain and spinal cord.

Immune and inflammatory mediators: substances with important role in the body defense against infections and in the inflammation.

More Information on Tolebrutinib is Available:

  • View the full Sanofi Tolebrutinib press release online here.
  • Download the full Sanofi- press release PDF here.
  • “Crossing Barriers to Deliver New Medicines” on the Sanofi Genzyme website  here.

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