Mayzent (siponimod), an approved oral therapy for active secondary progressive multiple sclerosis (SPMS), promotes a more regulatory immune system, which may explain its added benefits for SPMS, new clinical data show.
The study “Siponimod enriches regulatory T and B lymphocytes in secondary progressive multiple sclerosis” was published in the journal JCI Insight.
Novartis’ therapy is approved in Europe, Australia, and in the United States — where it also is approved for treating adults with clinically isolated syndrome (CIS) and relapsing-remitting disease (RRMS) — following the positive results of the Phase 3 EXPAND clinical trial (NCT01665144).
Active SPMS is defined by the presence of evident disease relapses or the detection of inflammatory activity in brain lesions on imaging scans.
Mayzent works by binding to two sphingosine-1-phosphate (S1P) receptors on the surface of immune cells, leading to the internalization and degradation of these receptors. This prevents immune cells in the lymph nodes from reaching the brain and spinal cord, which reduces the inflammatory processes that promote MS development and progression.
The mechanisms underlying Mayzent’s effects on the immune system remain unclear. However, its success in “slowing progression in active SPMS provides the first opportunity to determine the relevance of immune system modulation to disease progression in SPMS,” researchers wrote.
Researchers at the University of Michigan Medical School conducted an observational study, AMS04 (NCT02330965), that enrolled 36 SPMS patients who had participated in the EXPAND trial. Thirteen participants were assigned randomly to receive a placebo, and 23 participants received Mayzent. Participants were followed for up to 12 months.
The team investigated how Mayzent modulated gene levels by analyzing the transcriptome of patient’s blood samples. The transcriptome is the entire set of gene transcripts, meaning messenger RNA molecules constituting copies of the DNA sequence used to create proteins.
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