Novartis Announces New Clinical Data Demonstrating Mayzent's Significant Benefit on Cognitive Processing Speed in Secondary Progressive Multiple Sclerosis

In March this year, Mayzent (siponimod), developed by Novartis, received FDA approval for the treatment of patients with multiple sclerosis (MS). Recently, at the annual meeting of the American Academy of Neurology (AAN), Novartis presented further analyses of data from the Phase 3 clinical trials of this new drug. The latest analysis indicates that Mayzent can provide clinically meaningful improvements in cognitive processing speed (CPS) for patients with secondary progressive multiple sclerosis (SPMS).

Multiple sclerosis (MS) is a chronic central nervous system (CNS) disease caused by the immune system attacking the myelin sheath that protects nerves, affecting 2.3 million people worldwide. MS can be classified into three major types: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). SPMS is a stage that develops after RRMS, during which patients experience continuous neurological decline, leading to progressively worsening disability.

Cognitive decline is one of the key contributors to disability in multiple sclerosis (MS), affecting approximately 50–70% of MS patients and being more severe in those with secondary progressive multiple sclerosis (SPMS). These patients still have significant unmet needs.

Mayzent is a next-generation, selective S1P receptor modulator. It selectively binds to the S1P1 and S1P5 receptor subtypes. It not only prevents lymphocytes from entering the central nervous system (CNS), thereby exerting anti-inflammatory effects, but also directly penetrates the CNS to bind to receptors on oligodendrocytes and astrocytes, promoting remyelination.

▲Molecular structure of Mayzent (Image source: Vaccinationist [Public domain])

In the EXPAND trial, a randomized, double-blind, placebo-controlled Phase 3 clinical study, patients with secondary progressive multiple sclerosis (SPMS) across varying levels of disability received treatment with Mayzent or placebo. Previous data analyses have demonstrated that Mayzent reduced the risk of disability progression by 21%. Furthermore, in patients with SPMS, Mayzent reduced the rate of brain volume loss by more than 20% (p=0.0002). Brain atrophy is closely associated with cognitive decline and disability.

In the trial, researchers assessed patients’ cognitive processing speed using the Symbol Digit Modalities Test (SDMT). Cognitive processing speed is crucial for patients’ daily functioning, and its decline is often the earliest manifestation of cognitive impairment in patients with multiple sclerosis (MS), significantly adversely affecting their quality of life.

Trial data demonstrated that the proportion of patients treated with Mayzent who achieved sustained improvement in SDMT scores was significantly higher than that in the control group (p=0.0131). Moreover, patients receiving Mayzent treatment in the early stages of the disease derived greater cognitive benefits from the therapy.

“Cognitive decline is a major concern for patients with multiple sclerosis (MS), and this concern is even more pronounced in those with secondary progressive multiple sclerosis (SPMS),” said Dr. Ralph Benedict, Professor of Neuropsychology at Buffalo General Medical Center and one of the investigators of the EXPAND trial. “The results of this study represent an exciting finding for both SPMS patients and the scientific community. We are pleased to see that Mayzent can prevent cognitive decline, as preserving cognitive function is one of the key goals of disease-modifying therapies for MS.”

References:

[1] Novartis data at AAN show Mayzent's® positive impact on cognitive processing speed, a core element of cognitive function, in people living with secondary progressive MS. Retrieved May 9, 2019, from https://www.novartis.com/news/media-releases/novartis-data-aan-show-mayzents-positive-impact-cognitive-processing-speed-core-element-cognitive-function-people-living-secondary-progressive-ms

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