What’s New in MS Research – July 2026

Frexalimab reduces disease activity by up to three years in relapsing MS

The investigational disease-modifying therapy frexalimab demonstrated sustained reductions in disease activity for up to three years in people with relapsing forms of MS.¹

That finding emerged from the open-label extension period of a Phase II trial evaluating the safety and efficacy of the medication. Frexalimab is a monoclonal antibody – a laboratory-produced protein that mimics the activity of the body’s own antibodies in targeting antigens, such as bacteria or viruses, or other molecules or substances that can harm the body. Frexalimab targets CD40L, a protein found on the surface of T cells, immune cells that play a role in multiple sclerosis.

During the double-blind period of the trial that preceded the open-label extension, 129 people with relapsing forms of MS were assigned at random to receive either: 


• Frexalimab, 1200 mg, intravenous (IV) every four weeks
• IV placebo every four weeks
• Frexalimab, 300 mg, subcutaneous (SC) every two weeks
• SC placebo every two weeks

At Week 12 of the double-blind period, frexalimab was found to be well-tolerated. Further, compared to the matching placebo group, study participants receiving IV frexalimab had an 89% reduction in new gadolinium-enhancing (Gd+) T1 lesions seen on magnetic resonance imaging (MRI).


After Week 12, 125 study participants entered the open-label extension, with those in the placebo group switching to the respective frexalimab group – depending on whether the placebo was given via IV or SC. In the SC arms, the frexalimab dose was increased to 1800 mg every four weeks, a dose that is pharmacologically comparable to the IV dose of 1200 mg every four weeks.

At Week 144, or essentially three years, 100 study participants remained on treatment. The average number of Gd+ T1 lesions remained low in all treatment groups:

• Frexalimab IV group: 0.1 (meaning that over the course of one year, one person out of 1,000 would have a Gd+ T1 lesion)
• Placebo IV transitioned to frexalimab IV group: 0.3 (three people out of 1,000)
• Frexalimab SC group: 0.0 (no individuals would have a Gd+ T1 lesion)
• Placebo SC transitioned to frexalimab SC group: 0.1 (one person out of 1,000)

Researchers added that the monthly count of new or enlarging T2 lesions seen on MRI remained low among study groups, and that 86% of participants who were assigned to receive IV frexalimab at the outset of the study remained relapse-free through Week 144. They added that no new safety signals emerged over the three-year period. 

 

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Pilates shows several benefits in people with MS

An analysis of clinical trials involving 1,009 people with MS found that performing Pilates exercises yielded benefits ranging from reduced fatigue to higher serum levels of Vitamin D.² Further, some of the most favorable outcomes were seen in people who participated in Pilates classes remotely, such as through video conferencing.



Pilates is a low-impact mind-body exercise modality that emphasizes core strength, flexibility, posture, and mindful movement. It was developed about 110 years ago by German trainer Joseph Pilates as a means of physical rehabilitation, but it has since gained widespread popularity for the fitness benefits it offers all people.

After assessing the 30 randomized clinical trials included in their analysis, the researchers found that Pilates had:

• Large significant effects on fatigue and on two key MS biochemical markers, C-C motif chemokine ligand 20 and vitamin D
• Although no significant effect on depression was seen, there were small to moderately significant effects on walking, balance, and quality of life


They concluded, “Such findings support Pilates as a complementary mind-body exercise modality for symptom management and rehabilitation in MS. ”

While it is important to check with your MS clinician before embarking on any new exercise regimen, the results of this study suggest that Pilates may be a beneficial and convenient physical activity for many people with MS. This is particularly true in terms of the benefits that can be obtained by participating from your home via live video conferencing or watching videos.

 

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Identifying the uses and challenges of patient portals in MS care

More than four out of 10 people with multiple sclerosis participating in a recent survey rely on patient portals as their primary means of communicating with their MS care team.³

The Multiple Sclerosis Association of America (MSAA) developed and distributed the survey, which found that people’s main reasons for messaging their care team via portals included medication refills (67% of respondents), medical advice (53%), follow-up scheduling (42%), urgent concerns (39%), and visit clarification (38%). [Please note that “visit clarification” refers to questions you may have about what was discussed at a previous appointment with your doctor.] Survey participants also reported using portals to view test results (85% of respondents), to complete pre-visit forms (74%), and to access medical records (73%), among other reasons.

Those findings emerged from an analysis of 424 survey responses. Respondents were primarily White (83.3%), followed by Black (10.6%), and American Indian or Alaska Native (1.9%); 85.7% identified as not Hispanic. Thirty-five percent of respondents were 55-to-64 years of age, while 27% were 65-to-74 years of age, and 20% were in the 45-to-54 years of age group.

A majority (58%) said they messaged via the portal only when necessary, while 16% reported monthly portal messaging and 8% reported weekly messaging.

Fifty-nine percent of survey participants said they expected a response to their messages within 24 hours. In terms of challenges with using an online portal, 26% cited a lack of response from providers, while 20% expressed uncertainty about appropriate portal use and 18% identified character limits as an issue.



The study’s authors concluded that while people with MS highly value patient portal messaging, “gaps in expectations and guidance persist. Patient advocacy organizations and clinicians can support clearer communication norms and education around appropriate portal use, potentially improving care coordination, patient experience, and clinician well-being.”

 

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Study supports Mavenclad^® as a switch option for people with disease activity on other DMTs

A recent study suggests that the disease-modifying therapy (DMT) Mavenclad^® (cladribine) is a safe and effective option for people with relapsing forms of MS who experience high disease activity while taking other DMTs.⁴

The study involved 61 people with relapsing MS who were having relapses, disability progression, or magnetic resonance imaging (MRI) evidence of disease activity despite taking a moderate- or high-efficacy DMT. Study participants had a median age of 48 years and had been diagnosed with MS a median 9.5 years before starting Mavenclad. Medications taken prior to Mavenclad included Tysabri^® (natalizumab), Lemtrada^® (alemtuzumab), anti-CD20 therapies such as Ocrevus^® (ocrelizumab), and fumarate-class medications such as Tecfidera^® (dimethyl fumarate), among others.

Just before switching to Mavenclad, the group had an annualized relapse rate (ARR) of 0.7, meaning that over the course of one year, seven people out of 1,000 would experience a relapse. That rate declined to 0.23 one year after starting Mavenclad and fell further to 0.12 at 24 months.

Meanwhile, 92% of study participants with available MRI data had no imaging evidence of disease activity 12 months after starting Mavenclad. That proportion increased to 96.3% at 24 months, with both the 12-month and 24-month numbers representing improvements from baseline.

Researchers also tracked changes in study participants’ scores on the modified Expanded Disability Status Scale (mEDSS). The scale runs from 0 to 10, with higher scores indicating a greater degree of disability. The group’s median score increased from 4.0 at baseline to 4.8 at 12 months and then stabilized at 5.0 through 24 months.



In terms of safety, 46% of study participants had at least one adverse event. Lymphopenia – or an abnormally low level of lymphocytes, white blood cells that play a key role in fighting infection – was the most common adverse event and was reported in 23% of the people studied. However, lymphocyte counts generally recovered within six months of initiating Mavenclad and then were maintained through 24 months. Only one serious adverse event – a pseudo-relapse – was reported. Two people stopped participating in the study due to safety concerns, with one discontinuing because of a rash and the other because of a low lymphocyte count. There were no deaths or malignancies.

Mavenclad is an oral medication taken over the course of two years. Each yearly course consists of two separate 4- to 5-day treatment cycles taken about a month apart, with no further treatment for the balance of the year. The dose taken is determined by a patient’s weight.⁵ The patients taking the medication as part of this study were treated at 17 centers across the United States.

While most people with relapsing MS derive benefit from their initial DMT, some will experience ongoing disease. This study underscores the fact that while this is an unwelcome development, it is not a reason for becoming discouraged or giving up hope for improvement, as other viable options are available.

 

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Examining how an MS diagnosis affects family-planning decisions

Learning that you have multiple sclerosis can prompt a re-appraisal of one’s life plans, including those related to childbearing, but relatively little research has examined just how a diagnosis of MS affects family planning.

To address that gap, two neurologists from the University of Colorado School of Medicine surveyed 177 reproductive-aged women with MS receiving care at their institution in 2024 and 2025.⁶

Thirty-nine percent of survey respondents said that MS had no impact on their plans for starting or expanding a family. By contrast, 18% reported that they had chosen not to have children because of their diagnosis and 17% reported a change in the number of children they planned to have – with 86% of the women in that group saying they now planned to have fewer children than initially intended. Just under half – 49% – said that concerns about their ability to raise a child due to their health status was a key factor in their decision-making.

The survey respondents were mostly White (83%) and non-Hispanic (82%). In terms of disease severity, 37% reported having moderate symptoms at diagnosis. Among those who pursued pregnancy, 42% said that more than two years had passed between their last relapse or MRI change and their attempt to conceive.

Beyond identifying how an MS diagnosis shapes family-planning decisions, the survey also highlighted a need for enhanced patient-neurologist communication regarding those decisions:

• 63% of respondents said they did not discuss family planning with their initial neurologist, and 33% never discussed the topic with their treating neurologist
• Just 30% of respondents said they felt completely comfortable talking with their neurologist about family planning, while 26% said they were not at all comfortable discussing the subject with their neurologist
• When family planning was discussed, 51% reported initiating the conversation themselves

The research also found that nurse practitioners, nurses, and others may be filling any gap in patient-neurologist discussion, as 90% of survey respondents said members of the neurology care team were the healthcare professionals they consulted most often on questions of family planning.

In assessing the survey results, the study’s authors concluded, “These findings underscore the need for improved patient counseling, enhanced provider education, and standardized care pathways to better support family planning goals among patients with MS.”

 

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Studies demonstrate favorable outcomes with fenebrutinib for both relapsing MS and primary-progressive MS

The investigational medication fenebrutinib significantly reduced relapse rates and magnetic resonance imaging (MRI) evidence of disease activity relative to Aubagio^® (teriflunomide) in two studies involving almost 1,500 people with relapsing MS.⁷

FENhance 1 and FENhance 2 are similarly designed Phase III studies being conducted to evaluate the safety and efficacy of fenebrutinib. The oral disease-modifying therapy (DMT) belongs to a class of medications known as Bruton’s tyrosine kinase inhibitors, or BTKis. These medications modulate both B-cells and myeloid cells – such as microglia and macrophages – which play important roles in immune function and can contribute to the development of MS. BTKi medications cross the blood-brain barrier, enabling them to impact chronic inflammation in the central nervous system.

The 1,497 people enrolled in FENhance 1 and FENhance 2 had an average age of 35.8 years. Two-thirds were female, and one-third had MRI indications of disease activity at the start of the studies. The primary endpoint for both studies was annualized relapse rate, or ARR. (In calculating this rate, researchers determine how many relapses occur over a period of time in a group of people with MS. For example, if investigators monitored a group of 100 people for one year and one of those individuals had a relapse, the ARR would be 1.0).

In FENhance 1, the ARR was 0.061 for people receiving fenebrutinib and 0.125 for those taking teriflunomide, meaning that the rate for fenebrutinib was roughly one half that of teriflunomide. The results from FENhance 2 were similar, with an ARR of 0.054 for fenebrutinib and 0.130 for teriflunomide. That translates into a 42% lower relapse rate with fenebrutinib. The differences between treatment arms in both studies were statistically significant.

Other endpoints included T1 gadolinium-enhancing lesions and new or enlarging T2 lesions seen on MRI, two imaging findings that signify disease activity. In both studies, significant relative reductions in those lesions were seen with fenebrutinib compared to teriflunomide.

Turning to safety, 90.4% of people receiving fenebrutinib in FENhance 1 had at least one adverse event, as did 88.7% of the teriflunomide group. In FENhance 2, those proportions were 93.1% for people receiving fenebrutinib and 87.4% for teriflunomide.

Investigators reported that the rates of liver enzyme elevations were comparable in the fenebrutinib and teriflunomide arms of both studies. They added that in a pooled safety analysis of the two trials, there were eight deaths from various causes among people receiving fenebrutinib versus one death in the teriflunomide group. As noted later, all of the fatalities were assessed to be unrelated to the study treatment.

These findings on the impact of fenebrutinib in relapsing MS are accompanied by positive outcomes for the medication in primary-progressive multiple sclerosis (PPMS), as reported at the May 2026 Consortium of Multiple Sclerosis (CMSC) meeting and elsewhere. 


The Phase III FENtrepid trial assessed the efficacy and safety of fenebrutinib compared to Ocrevus^® (ocrelizumab) – an intravenously infused medication that is currently the only disease-modifying therapy (DMT) approved for the treatment of PPMS – in 985 people with PPMS.

In the study, fenebrutinib had a 12% reduction in risk of disability progression compared to Ocrevus.^8,9 This reduction in disability risk – looking at time to onset of confirmed disability progression at 12-weeks – was the study’s primary endpoint. The endpoint was defined as a 12-week confirmed increase in one or more of three measures: Expanded Disability Status Scale (EDSS) score, Timed 25-Foot Walk Test, and 9-Hole Peg Test.



Conducted at 189 sites in the United States and other countries, FENtrepid enrolled people with PPMS who were 18-to-65 years old and who had an EDSS score of 3.0 to 6.5. Participants had an average age of 48.9 years at the start of the trial and a median score of 5.0 on the 10-point EDSS scale.

Study participants were assigned in random fashion to receive oral fenebrutinib 200 mg twice daily or intravenous ocrelizumab 600 mg every 24 weeks. They remained on treatment for at least 120 weeks.¹⁰

Adverse events included:

• Infections – reported in 67.0% of people receiving fenebrutinib and 70.9% of those receiving Ocrevus
• Nausea – 12.0% in the fenebrutinib group and 7.0% in the Ocrevus group
• Transient and reversible liver enzyme elevations – 13.2% and 2.9%, respectively

Serious adverse events were reported in 19.1% of participants receiving fenebrutinib and 18.9% of those treated with Ocrevus. Those side effects prompted 4.3% of patients in the fenebrutinib group and 3.0% of Ocrevus patients to withdraw from treatment. The rate of fatal cases was 1.4% in the fenebrutinib group versus 0.2% in the Ocrevus group; all of the fatalities were assessed to be unrelated to the study treatment. Further, no pattern was observed in the timing or causes of those deaths.

Researchers reporting the outcomes of the FENhance 1 and FENhance 2 studies noted, “With positive results in both PPMS and RMS, [fenebrutinib] is the first oral BTKi to demonstrate efficacy on both relapsing and progressive biologies.”

Genentech, the biotechnology company developing fenebrutinib, said earlier this year that it planned to seek Food and Drug Administration (FDA) approval for fenebrutinib in the treatment of both PPMS and relapsing MS following release of findings from the relapsing MS studies.

 

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Keeping all of your doctors “in the loop” on all of your medications

Does your primary care provider know all of the medications you’re taking for your MS and other conditions?

In a British study involving 66 people with MS, just 12% of study participants reported that their primary care clinician had reviewed their medication list with them in the prior year.¹¹ That lack of communication is concerning due to the potential for drug-to-drug interactions.

Additionally, some medications have side effects that may be particularly problematic for people with MS. For example, 5% of study participants were taking anticholinergic medications, which can help with bladder control, but which also can increase the balance problems that are quite common among people with MS. 


The study analyzed data on people receiving care through the Lewisham & Greenwich National Health Service Trust in southeast London. Half of those people were taking Ocrevus^® (ocrelizumab) for their MS, while the other half were receiving natalizumab, a disease-modifying therapy marketed as Tysabri^® or, in biosimilar form, as Tyruko^®.

Study participants receiving Ocrevus were taking an average of 3.1 medications, while those receiving natalizumab were taking 3.7 medications. Beyond their DMTs, the participants’ most frequent types of medications are shown below:

Medication type	Ocrelizumab group (n=33)	Natalizumab group (n=33)
Antidepressants	25%	27%
Pain relievers	23%	24%
Vitamins, supplements	25%	22%
Antispasmodics	14%	19%


When it comes to ensuring that your healthcare providers are aware of all the medications you are taking, it is important to review all of them at each visit.

 

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One more reason to stop smoking: increased risk of DMT not working

Smoking significantly increases the risk that people with MS will not respond to many types of disease-modifying therapies (DMTs).¹²

Researchers reached that conclusion after looking at how factors including smoking and obesity affected response to DMTs including interferons, glatiramer acetate such as Copaxone^® and Glatopa®, fumarates, sphingosine-1-phosphate receptor modulators, Tysabri^® (natalizumab), Aubagio^® (teriflunomide), and anti-CD20 therapies. Non-response was defined as new lesions on magnetic resonance imaging and/or clinical relapse within two years of starting a medication.

The investigators reported that current smokers were 1.8-to-2.6 times more likely than non-smokers to not respond to their medication, with that range reflecting differences between types of DMTs. Meanwhile, people who were obese were 2.1 times more likely than others to not respond to interferon-based therapies. Interestingly, neither smoking nor obesity posed an increased risk of non-response to anti-CD20 medications, such as Briumvi^® (ublituximab), Kesimpta^® (ofatumumab), and Ocrevus^® (ocrelizumab).

Now for the good news: While current smoking was associated with an increased risk of non-response to many DMTs, no such association was seen in former smokers. Who says quitters never win?

 

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One study finds that stopping versus continuing Ocrevus^® impacts hospitalization rate in people over 50

Many of the decisions people face as they grow older involve determining when it’s time to stop doing something – working, residing in their long-time home, or perhaps playing a sport that is physically challenging. For some older people with MS, that decision-making also entails considering whether a long period of stability on their disease-modifying therapy (DMT) indicates that it’s safe to stop taking the medication.

A recent study involving more than 1,300 people with MS who were aged 50 years or older and taking Ocrevus^® (ocrelizumab) found that discontinuing that DMT was associated with higher hospitalization rates, length of stay in the hospital, and costs related to hospitalization.¹³

The retrospective study drew on claims data from January 2018 through June 2024 for 683 people age 50 years or older who had discontinued Ocrevus and another 683 who continued to take the medication. Discontinuation was defined as a 90-day treatment gap or switching to a lower-efficacy therapy.

Here’s how the two groups differed in the measures analyzed:

	Discontinuation Group (n=683)	Continuation Group (n=683)
Hospitalizations for any cause
Hospitalization rate per 1,000-person days	0.48	0.15
Average length of stay, days	5.1	0.9
Average inpatient costs, dollars	$10,186	$4,295
MS-related hospitalizations
Hospitalization rate per 1,000-person days	0.46	0.13
Average length of stay, days	4.5	0.8
Average inpatient costs, dollars	$6,682	$3,099

The study’s authors noted that the higher healthcare utilization and costs seen in people who stopped Ocrevus suggested that “discontinuation may be premature and linked to increased disease activity or disability progression following treatment withdrawal,” adding that “age-related immune decline and comorbidities may exacerbate disease reactivation.”

Decisions regarding continuing or stopping a DMT can be complex, and should be made in consultation with your MS clinician. An MS specialist can provide key guidance regarding your current status and possible disease course, the impact of comorbidities, potential drug-to-drug interactions, and other factors that merit careful consideration.

 

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Studies examine the extent and impact of accelerated brain aging in MS

Two separate studies conducted by researchers at Wayne State University, the University of Michigan, and other institutions, used neuroimaging and artificial intelligence (AI) to assess the gap between brain age and chronological age in people with MS. These studies also looked to determine how accelerated brain aging in MS correlates with functional deficits.

In the first study, investigators obtained whole-brain magnetic resonance imaging (MRI) sequences from 124 people with MS and 33 healthy controls. They then assessed those images to determine each person’s “brain age” based on standard values for key anatomical characteristics of the brain at different chronological ages. The images were assessed through AI, using the “brainageR” package to determine brain-predicted age estimates.¹⁴

Study participants with MS had an average age of 39 years but a median brain-predicted age of 53.3 years (a difference of 14.3 years). By comparison, the healthy controls had an average age of 30 years and a median brain-predicted age of 31.8 years (a difference of 1.8 years), which is a much smaller gap between chronological age and age indicated by brain characteristics seen on MRI. Further, the study participants with MS showed a significantly greater loss of gray matter and white matter volume than the controls.

In the second study, researchers explored a potential relationship between accelerated brain aging and functional limitations in people with MS.¹⁵

The investigators assessed MRI images from 43 people with MS to predict those people’s ages based on different brain characteristics. In this second study, the images were assessed through AI, using the “PyBrainAge” system to determine brain-predicted age estimates.

They then compared those brain-predicted ages with the people’s chronological ages. They found that study participants had an average brain-predicted age 8.4 years greater than their chronological age. Versus the first study, this second study showed a smaller, but still significant gap in chronological age versus brain age.

The researchers then examined whether that brain-predicted age difference (Brain-PAD) among participants in this second study correlated with people’s performance on various mobility tests and real-world physical activity. They found that Brain-PAD could predict mobility outcomes even after accounting for a person’s chronological age and disability status.

Noting that their study “is among the first to link MRI-derived biological brain aging to both objective motor impairment and real-world behavior in MS,” the researchers concluded, “These findings support Brain-PAD as a sensitive biomarker of functional vulnerability and highlight its potential utility for identifying individuals who may benefit from early, targeted mobility and neuroprotection strategies.”

 

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Phase IV trial demonstrates improved quality of life in people newly diagnosed with relapsing-remitting MS taking Kesimpta^®

People with very early relapsing-remitting MS who received Kesimpta^® (ofatumumab) in a Phase IV trial reported improved quality of life and no increase in functional disability over 18 months of treatment.¹⁶

Kesimpta is a disease-modifying therapy (DMT) administered by subcutaneous injection. It works by binding to a protein called CD20 on the surface of B cells. These white blood cells are a component of the immune system and normally protect a person’s health.

In multiple sclerosis, however, B cells mount an autoimmune response, mistakenly attacking the myelin sheath around nerves in the brain and spinal cord. By binding to and ultimately destroying B cells, Kesimpta dampens this autoimmune response, reducing relapses and slowing disability progression. The Phase IV AGNOS trial is an 18-month, open-label, multicenter study assessing the safety and efficacy of Kesimpta in previously untreated patients 18-to-35 years of age who were diagnosed with MS within six months of trial entry. For comparative purposes, the study also includes “healthy controls,” which are people in the same age range who don’t have MS.

In a recently reported analysis from the trial, people in the Kesimpta group were an average age of 28.1 years, and 75% were female. Median time from first MS symptoms to starting treatment was just over one year. The average age of people in the control group was 27.4 years, and 61% were female.

Using a test called the Quality of Life in Neurological Disorders (Neuro-QOL), researchers found that people in the Kesimpta group and control group both had favorable changes in their average “t scores” from the start of the study to Month 18 in all domains measured (“t scores” refer to a standardized score that assesses how much one value differs from the average score).

In general, fatigue, sleep disturbance, anxiety, and depression decreased for both groups, with improvements in fatigue and sleep disturbance being significantly greater in the Kesimpta group. In addition, lower- and upper-extremity function improved for both groups, but the treated group experienced roughly twice the degree of improvement over the placebo group. Cognitive function increased for both groups, although the change was much smaller for the treated group versus those taking the placebo.

People in the Kesimpta group were also assessed with an instrument called the Patient Determined Disease Steps (PDDS). After a slight average decline in their PDDS scores at the six-month mark, those scores stabilized at Month 12 and remained stable at Month 18. In previously published study results, 81% of trial participants receiving Kesimpta had no evidence of relapse, confirmed disability progression, or magnetic resonance imaging indications of disease activity from study months six to 18.

The finding that people with very early relapsing-remitting MS “moved in the same direction” as people without MS, showing improvement in seven areas affecting quality of life, provides encouragement to people newly diagnosed with multiple sclerosis and underscores the importance of prompt initiation of treatment.

 

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Investigational medicine vidofludimus calcium shows safety similar to placebo in Phase II trial

Researchers reported that the investigational disease-modifying therapy vidofludimus calcium demonstrated safety and tolerability similar to that of placebo in the Phase II CALLIPER trial, assessing its role in the treatment of progressive forms of MS.¹⁷

CALLIPER was a randomized, double-blind, placebo-controlled trial that enrolled 467 participants aged 18 to 65 years. Of that total, 152 study participants had been diagnosed with primary-progressive MS, while 315 had secondary-progressive MS.

The participants were randomly assigned on a 1:1 basis to receive either 45 mg of vidofludimus calcium (VidoCa) or placebo. The duration of the study’s double-blind treatment period was up to 120 weeks.

In focusing on the study’s safety data, the researchers reported that the frequency of adverse events and infections were similar between both groups. Headache and back pain were experienced more often in the placebo group, while serious treatment-emergent adverse effects were higher in the treatment group. The specific findings are shown in the chart to follow:

	VidoCa Group (n=235)	Placebo group (n=232)
Any treatment-emergent adverse event (TEAE), % of patients affected	69.4	68.5
Infections, %	68.5	65.5
Urinary tract infection, %	16.6	15.5
Headache, %	4.3	6.9
Back pain, %	3.8	7.3
Serious TEAEs, %	8.1	6.5

Additionally, researchers said that levels of the liver enzyme aspartate aminotransferase more than three-times the upper limit of normal (ULN) were observed in 2.2% of people in both the treatment and placebo groups, while such elevations of the liver enzyme alanine aminotransferase occurred in 3.0% of people in the VidoCa group and in 2.6% of those receiving placebo. 


Summarizing their findings, the researchers said, “These observations confirm the favorable safety profile of VidoCa.”

Researchers reporting the CALLIPER study’s safety data at the May meeting of the Consortium of Multiple Sclerosis Centers (CMSC) noted that efficacy results from the trial showed positive trends in confirmed disability worsening in the overall study population as well as across subpopulations and disability end points. 


Vidofludimus calcium activates nuclear receptor-related 1 (NURR1), a protein that helps to regulate genes that enhance the survival of neurons. Growing evidence supports NURR1 playing a protective role in neurodegenerative diseases. In addition, VidoCa is a selective inhibitor of an enzyme (dihydroorotate dehydrogenase) believed to play a role in the development of autoimmune diseases.

To date, no NURR1 activators have been approved by the Food and Drug Administration (FDA) to treat multiple sclerosis. If VidoCa should secure FDA approval on the basis of clinical trial results, it would provide clinicians with a new means of treating MS by targeting a previously unaddressed disease mechanism.

 

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Drawing on patient and clinician insights to speed MS diagnosis and enhance care

Three quarters of people with multiple sclerosis participating in a recent survey had symptoms of the disease for more than one year before being diagnosed with MS, with more than 40% experiencing diagnostic delays of five years or longer.¹⁸

Developing strategies to eliminate such delays is one of the goals of the Multiple Sclerosis Implementation Network (MSIN). MSIN is a patient-driven practice-based research network bringing together MS clinicians, patient advocacy organizations, clinical and implementation science researchers, and industry partners to improve care quality and outcomes.

More than 400 people with MS completed the survey. Those individuals, who live in 43 states across the country, reported that common reasons for delayed diagnosis include a lack of recognition of initial symptoms by patients (cited by 46% of respondents) and symptoms being dismissed or not recognized by providers (38%). They added that key barriers to receiving quality MS care are insurance or medication approval delays (35%), high out-of-pocket costs (23%), and poor communication among doctors (15%).

Beyond surveying people with multiple sclerosis, MSIN drew on its community of practice (CoP), which connects MS healthcare professionals and clinics to share best practices and address challenges, to obtain insights from clinicians. MS providers at 15 MSIN clinical sites who participated in virtual meetings said that the people at highest risk for a delayed diagnosis of MS include those with:

• Lower socioeconomic status
• Rural residence
• Atypical/mild symptoms
• Limited access to primary care

Clinicians participating in the CoP discussions added that barriers to optimal MS care include restricted access to high-efficacy therapies due to insurance processes, fragmented care coordination, limited multidisciplinary support, and inadequate tools to detect subtle disease progression.

Turning to solutions, patients and clinicians identified several key strategies: early use of high-efficacy therapies, education, care navigation, expanded access to multidisciplinary and lifestyle-focused care, and use of biomarkers to inform treatment decisions and monitoring.

 

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Assessing the safety of anti-CD20 medications when given via home infusions

Overseen and administered by a nurse, home administration of intravenously infused anti-CD20 medications is a safe, convenient alternative to having people with MS travel to a medical facility for infusions, a recent study found.¹⁹

The retrospective chart review examined 520 home visits to 223 patients with MS. The visits occurred between December 2021 and March 2024. Anti-CD20 medications are disease-modifying therapies (DMTs) that target and destroy B cells – a type of white blood cell that plays a role in MS – by binding to the CD20 protein on the surface of those cells.

While anti-CD20 medications are considered highly efficacious in treating MS, they can cause allergic reactions and other infusion-related side effects. Most of these reactions are mild, but some can be severe, making it important to assess the safety of administering the medications in a patient’s home rather than in a medical setting.

Adverse events occurred with 22% of the home infusions, but none were serious. Just under half occurred during or following the infusion. When a patient experienced a side effect, the home visit was an average of 24 minutes longer than visits without an adverse event, but did not entail longer administration time of the medication. Meanwhile, home infusion enabled people receiving the therapy to avoid an average 1.7 hours of travel time to and from a doctor’s office or similar medical facility.

 

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Tiziana reports key milestone in trial of intranasal foralumab

The Phase IIa INFORM-MS trial evaluating the investigational medication intranasal foralumab for treatment of non-active secondary-progressive multiple sclerosis (na-SPMS) marked a key milestone recently, when the study’s last patient received an initial dose of the medication.²⁰

Tiziana Life Sciences, the Boston-based biotechnology company developing intranasal foralumab, reported the news in a June 25, 2026 press release, adding that topline data from the trial is expected late in the third quarter or early in the fourth quarter of 2026.

When a medication is given intranasally (into the nostrils), it is less invasive than an injection or infusion, reducing the risk of systemic side effects. The nasal mucosa is a layer of tissue that lines the nasal cavities and connects with the brain and respiratory tract. This form of administration allows for the quick absorption of a medication and improves its bioavailability, which is the amount of medication entering the blood system. With oral medications, a portion of the medication is digested, so less gets into the bloodstream.

INFORM-MS is a randomized, double-blind, placebo-controlled Phase IIa trial assessing the safety, tolerability, and efficacy of two doses of intranasal foralumab versus placebo in up to 48 patients with na-SPMS. The study includes multiple US investigational sites and is assessing imaging biomarkers and clinical outcomes.

Foralumab is an anti-CD3 fully human monoclonal antibody. Monoclonal antibodies (mAbs) are laboratory-produced proteins that mimic the immune system’s antibodies. Like antibodies produced by the human body, mAbs locate and bind to a single type of target – an antigen – such as a protein on a cancer cell, virus, or inflammatory cell. Foralumab targets CD3, a protein complex on the surface of T cells, which are immune cells that have been shown to play a role in multiple sclerosis.

Foralumab is the only fully human anti-CD3 mAb currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases, including MS.

 

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Findings presented on Ocrevus^® exposure just before and during pregnancy

Women with MS who potentially were exposed to Ocrevus^® (ocrelizumab) just before conceiving or while pregnant had pregnancy outcomes similar to those of other women with MS not exposed to the disease-modifying therapy (DMT).²¹

That reassuring finding emerged from an analysis of 1,309 pregnancies in women who had been prescribed Ocrevus. Of that total, 763 (58%) of the pregnancies occurred in women potentially exposed to Ocrevus within three months of their last menstrual period (LMP) or during pregnancy, while 546 were in women not exposed to Ocrevus during that timeframe.

The majority of potential exposures – 513 of the 763 – occurred in the three months prior to a woman’s last menstrual period, while only 24 occurred in the second or third trimester. Potential exposure was determined by considering how long Ocrevus was likely to remain in a woman’s system based on chemical characteristics such as its half-life, which is the estimated time it takes for the active ingredient of a medication to decrease by half within the body.

The researchers examined several pregnancy outcomes in the women who potentially had been exposed to Ocrevus and those who had not been exposed, with the following results:

Pregnancy outcome	Potentially exposed pregnancies (n=763)	Non-exposed pregnancies (n=546)
Live birth	86.9%	89.9%
Preterm birth	9.2%	6.9%
Spontaneous abortion (Miscarriage)	6.7%	8.1%
Stillbirth	0.4%	0.0%

The researchers found a higher rate of elective or therapeutic pregnancy terminations, or abortions, in the potentially exposed group: 5.4% versus 1.5% in the non-exposed group. They reported that women in the two groups had similar reasons for the terminations and that most terminations occurred early in gestation.

In summarizing their findings, the researchers noted maternal exposure to the medication “did not increase risk of adverse pregnancy or infant outcomes compared with epidemiological rates in both the MS and general populations.”

In keeping with similar guidance for other DMTs, the prescribing information for Ocrevus advises women of reproductive potential to use effective contraception while receiving Ocrevus and for six months after their last infusion of the medication.²²

While it remains essential to follow that guidance, and to talk with your MS clinician before discontinuing family planning methods or pursuing pregnancy.

 

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References

1. Vermersch P, Granziera C, Mao-Draayer Y et al. Efficacy and safety of frexalimab in participants with relapsing multiple sclerosis: 3-year results from the phase 2 open-label extension. DMT01. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
2. Najafi P, Huynh TLH, Declerck L, Motl RL. Pilates in multiple sclerosis: a systematic review and meta-analysis of biochemical, psychological, and physical outcomes. CAM01. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
3. Hersh CM, Kline A, Rivera Y, et al. Patient perspectives on portal messaging in multiple sclerosis care: insights and opportunities. QOL22. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
4. Hendin B, Kaplan J, Hooshmand SI, et al. Effectiveness and safety of switching to cladribine tablets in people in the United States with relapsing multiple sclerosis experiencing high disease activity or disease breakthrough despite current disease-modifying therapy use. DMT14. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
5. EMD Serono. Mavenclad^® (cladribine) tablets 10 mg, Dosing Guide. April 2022. Rockland, Massachusetts.
6. Upchurch M, Shah A. Evaluation of the impact of a diagnosis of multiple sclerosis on family planning: a survey-based study. MOC07. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
7. Oh J, Bar-Or A, Giovannoni G, et al. Efficacy and safety of fenebrutinib vs teriflunomide in relapsing multiple sclerosis: results of the FENhance 1 and 2 studies. LBA01. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
8. Genentech. Genentech’s fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS). February 7, 2026. Available at https://www.gene.com/media/press-releases/15098/2026-02-07/genentechs-fenebrutinib-is-the-first-inv. Accessed February 25, 2026.
9. Bar-Or A, Oh J, Giovannoni G, et al. Efficacy and safety of fenebrutinib vs ocrelizumab in primary progressive multiple sclerosis: primary results of the Phase III FENtrepid Study. DMT06. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
10. National Library of Medicine. A study to evaluate the efficacy and safety of fenebrutinib compared with ocrelizumab in adult participants with primary progressive multiple sclerosis (FENtrepid). (NCT04544449.) Available at https://clinicaltrials.gov/study/NCT04544449. Accessed March 21, 2026.
11. Changaradil DV, Perfect L. Polypharmacy in multiple sclerosis: a cross-sectional analysis and development of a clinical assessment tool. SYM03. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
12. Kumar G, Massey K, Khan M, Allushi B, Pardo G. Distinct demographic and inflammatory modifiers of treatment nonresponse across multiple sclerosis therapies. EP102. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
13. Pineda ED, Patel A, Sheinson D, et al. Real-world impact of discontinuing ocrelizumab on health care resource utilization and cost among older adult patients with multiple sclerosis in the United States. DMT20. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
14. Bao F, Nourelden AZ, Memon B, et al. Accelerated brain aging and volume loss in multiple sclerosis: a cross-sectional MRI study. IMG06. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina
15. Monaghan PG, Takla TN, Cole JH, et al. Accelerated brain aging identifies functional deficits not captured by chronological age in multiple sclerosis. WHI01. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
16. Hendin B, Wray S, Chinea AR, et al. Patient-reported outcomes in treatment-naive patients with very early relapsing-remitting multiple sclerosis treated with ofatumumab: results from the AGNOS Study. QOL02. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
17. Muehler A, Sciacca V, Ondrus M, et al. Safety and tolerability of vidofludimus calcium, a direct nuclear receptor-related 1 activator and selective dihydroorotate dehydrogenase inhibitor: data from the Phase 2 CALLIPER trial. DMT11. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
18. Freeman L, Balasubramanian B, English AS, et al. Mapping the multiple sclerosis care journey: integrating lived experience and clinician insight to drive implementation through the Multiple Sclerosis Implementation Network. MDC02. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
19. Pitts S, Wright L, Johnson J, Bridges G. Real-world patient safety and experience trends for anti-CD20 home infusion: a 120-week review. DMT49. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.
20. Tiziana Life Sciences, Ltd. Tiziana announces last patient successfully dosed in its Phase 2 INFORM-MS trial. June 26, 2026. Available at https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-announces-last-patient-successfully-dosed-its-phase-2. Accessed July 10, 2026.
21. Krysko KM, Dobson R, Vukusic S, et al. A decade of pregnancy outcomes in women with multiple sclerosis receiving ocrelizumab: analysis of over 5000 pregnancies. DMT05. Consortium of Multiple Sclerosis Centers 2026 Annual Meeting, May 27-30, 2026, Charlotte, North Carolina.


22. Ocrevus^® (ocrelizumab) injection, for intravenous use. Prescribing information. May 2026. Genentech, Inc. South San Francisco, California.

 

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For More Information

For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Tom Garry, Medical Writer
Reviewed by Dr. Barry Hendin, MSAA Chief Medical Officer
Edited by Susan Wells Courtney, MSAA Senior Writer

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.