Research News
By Tom Garry
Edited by Susan Wells Courtney
Reviewed by Dr. Barry A. Hendin, MSAA’s Chief Medical Officer
MSAA’s MSIN® Initiative Assesses the Evidence for a Wide Range of MS Interventions Beyond DMTs
While extremely important, comprehensive management of MS entails far more than taking disease-modifying therapies (DMTs). Health promotion, attention to symptoms, and supportive care all play critical roles, but often are not as rigorously studied as DMTs, which must be evaluated in large clinical trials to receive United States Food and Drug Administration (FDA) approval. As a result, it can be difficult for people with MS and their clinicians to know which other interventions have solid evidence supporting their efficacy and safety.
As an initial step toward bridging that evidence gap, the Multiple Sclerosis Implementation Network® (MSIN®) conducted a scoping review to assess the breadth and focus of research into various facets of MS management.1 “A scoping review is useful to map the literature on evolving or emerging topics and to identify gaps.”2
MSAA’s MSIN initiative evaluated 1,049 articles in medical and scientific journals before identifying 208 studies that met its inclusion criteria. Those studies were authored by researchers in 33 countries, with the United States, Iran, Italy, Turkey, and Spain accounting for 69% of the studies.
The five most frequently studied aspects of MS outside of DMTs were symptom management (53.8%), motor function and disability (44.2%), activities of daily living (29.3%), cognitive function (21.2%), and psychological well-being (20.2%). In terms of the types of interventions evaluated, exercise led the way, representing 47.6% of the studies.
Roughly 14% of studies looked at multi-component interventions, such as programs that combined education, rehabilitation, exercise, and brain stimulation. Dietary and nutritional interventions constituted the least-researched area, being the focus of only 1.4% of studies. The authors of the scoping review noted that most of the evidence-based interventions evaluated were developed by single research teams without independent replication, a detail that is critical for validating study data.
As a next step from the scoping review, “each intervention will be prioritized based on the strength of the evidence, potential impact on patient outcomes, alignment with patient and stakeholder priorities, and feasibility of adoption and implementation across MSIN [clinical] sites.”1
By carefully assessing and implementing various health promotion, symptom management, and supportive steps in this manner, MSIN’s effort can help drive adoption of truly comprehensive MS care.
Sandoz Announces Launch of Tyruko®
Tyruko® (natalizumab-sztn), the first approved biosimilar for the long-term treatment of multiple sclerosis (MS), is now available in the United States. Marketed by Sandoz, Tyruko is a biosimilar to Tysabri® (natalizumab), and as with Tysabri, Tyruko is approved to treat relapsing forms of MS.
Because it is a biosimilar to Tysabri, Tyruko is given at the same dosage and via the same administration as Tysabri (IV infusion every four weeks), while also carrying the same benefits and risks. A rare but serious risk of Tysabri, as well as certain other immunosuppressants, is the development of progressive multifocal leukoencephalopathy (PML), an often-fatal viral infection of the brain. Caused by the John Cunningham virus (JCV), the risk of developing PML can be reduced by testing for JCV antibodies in advance.
Although Tyruko was originally approved by the Food and Drug Administration (FDA) in 2023, the November 2025 launch of Tyruko was initially delayed as the makers waited for the approval of a JCV antibody test.
Similar to Tysabri, Tyruko is available through a Risk Evaluation and Mitigation Strategy (REMS) program to inform healthcare providers and patients about the risk of PML associated with this treatment. Sandoz has partnered with Labcorp in developing this JCV testing, and Sandoz will cover the cost for eligible patients.
Trio of MS Medication Trials Yield Disappointing Results
The closing weeks of 2025 brought news of three MS medication studies that did not meet their primary endpoints.
In the first study, dubbed MS-STAT2, British researchers examined whether the cholesterol medication simvastatin could slow disability progression in secondary-progressive multiple sclerosis (SPMS).3 A Phase II study lent support to this idea by showing that people with SPMS taking simvastatin daily had less brain atrophy over time than others with SPMS who received placebo.
On the basis of those findings, the British researchers proceeded to the Phase III, randomized, MS-STAT2 study, which involved 964 people with SPMS. Unfortunately, as reported in October in the Lancet medical journal, the study did not show simvastatin to be beneficial in reducing six-month confirmed disability progression (CDP), which occurred in 36% of people in the placebo group and 40% of those receiving simvastatin.
Late November brought news that PIPE-307, an investigational medication being developed by Contineum Therapeutics, did not meet its primary or secondary efficacy endpoints in the Phase II VISTA trial assessing its use in people with relapsing-remitting MS.4 PIPE-307 belongs to a class of medications known as M1 receptor antagonists. These medications block the neurotransmitter acetylcholine at muscarinic M1 receptors in the central nervous system (CNS), which can have an impact on nerve signaling.
And finally, in December, the French biopharmaceutical company Sanofi announced that the Phase III PERSEUS study evaluating its investigational medication tolebrutinib did not meet its primary endpoint of delaying time to six-month composite confirmed disability progression (cCDP) in study participants with primary-progressive multiple sclerosis (PPMS). Tolebrutinib is an investigational, oral, brain-penetrant Bruton’s tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS.
Although Sanofi will no longer pursue regulatory registration of tolebrutinib for PPMS given these disappointing study results,5 they are continuing to seek approval of tolebrutinib for use in non-relapsing secondary-progressive MS (nrSPMS). However, while a decision on whether to approve tolebrutinib for use in nrSPMS was expected in December from the United States Food and Drug Administration (FDA), they instead issued a complete response letter asking Sanofi to provide more data to support its application for the approval.6
While these developments would seem to affirm the notion that “bad news comes in threes,” there undoubtedly are silver linings within the findings from all three studies in terms of data points and patterns that can help researchers refine approaches, shift focus, and hopefully achieve better results going forward.
Medical details and study results provided in MSAA’s published materials are for informational purposes only and are not to be considered as treatment advice or recommendations. Readers are encouraged to consult a healthcare professional before making any changes to their current treatment regimen.
References
1. Obekpa EO, Silveira SL, Yamal J-M, et al. Evidence-based health promotion, symptom management, and supportive care interventions for people with multiple sclerosis: a scoping review. P433. ECTRIMS 2025.
2. Mak S, Thomas A. Steps for Conducting a Scoping Review. J Grad Med Educ. 2022 Oct;14(5):565-567.
3. Chataway J, Williams T, Blackstone J, et al. Effect of repurposed simvastatin on disability progression in secondary progressive multiple sclerosis (MS-STAT2): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025;406 (10512):1611-1624.
4. Contineum Therapeutics. Contineum Therapeutics reports topline data from its phase 2 PIPE-307 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS). San Diego, CA. November 20, 2025.
5. Sanofi. Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis. Paris, France. December 15, 2026.
6. Sanofi. Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis. Paris, France. December 24, 2026.