The effectiveness of Mayzent (siponimod) in both the brain and the body make it an oral therapy tailored for people with early secondary progressive multiple sclerosis (SPMS), according to Dan Bar-Zohar, MD, top executive with Novartis, the treatment’s developer.
Mayzent was recently approved by the U.S. Food and Drug Administration (FDA) for adults with relapsing forms of multiple sclerosis (MS), which, besides “active” SPMS, included clinically isolated syndrome and relapsing-remitting disease (RRMS).
In studies like the pivotal EXPAND Phase 3 clinical trial (NCT01665144), “we saw an effect on brain volume loss reduction which may be indicative for increased remyelination and a decrease in the diffuse damage, and we’re very excited about that,” Bar-Zohar, global head of neuroscience development at Novartis, said in an interview last week with Multiple Sclerosis News Today.
The decision to develop the therapy was based on the efficacy of compounds known as S1P receptor modulators in MS. Gilenya (fingolimod, also marketed by Novartis), is such an example, as it targets the S1P1 subtype found in nerve cells and immune brain cells called microglia.
Mayzent also has very high affinity for another subtype, called S1P5.
“The thinking with siponimod [Mayzent] is that it tickles different subsets of S1P receptors, and the thought was that it could be more effective, particularly in progressive MS than, for example, fingolimod (Gilenya),” Robert Fox, a neurologist at the Cleveland Clinic, said in a separate interview.
That’s because Mayzent enters the brain “avidly,” Fox and Bar-Zohar said, where two cell types implicated in the accumulation of injury contain high levels of S1P5: astrocytes, involved in the formation of the blood-brain barrier, and oligodendrocytes, the cells that form the myelin sheet around nerve fibers.
Preclinical work in animals suggested that Mayzent acts through S1P5 on these cells to ease clinical symptoms of progressive disease. This work “suggests that Mayzent has beneficial effects through these cells, through … astrocyctes and through oligodendrocytes in order to ameliorate clinical symptoms of progressive disease,” Bar-Zohar said.
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