Trial results

The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…

People with secondary progressive multiple sclerosis (SPMS) who began treatment with Mayzent early and continued its use for years are less likely to experience disability progression than those starting the medication later in their disease course, five-year data from the EXPAND study suggest. Data from this same Phase 3…

Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…

Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…

Cognitive behavioral therapy, a type of “talk” therapy, may help ease the severity of insomnia, fatigue, and anxiety in people with multiple sclerosis (MS), improving the quality of their sleep, data from a single-site trial suggest. The study “Feasibility and Treatment Effect of Cognitive Behavioral Therapy for Insomnia…

Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show. That means Gilenya provides an effective treatment option for…

Second Phase 3 Trial of MedDay’s MD1003 for Progressive MS Fails to Meet Goals This is disappointing news about what scientists had hoped would be another oral disease-modifying therapy for multiple sclerosis. It’s doubly disappointing because MD1003 is aimed at progressive forms of MS and demyelination, and we need…

MedDay Pharmaceuticals‘ MD1003 did not ease functional disability or its progression in patients with non-active progressive multiple sclerosis, Phase 3 clinical trial data shows. The SPI2 Phase 3 study (NCT02936037) sought to confirm the positive results of a first Phase 3 trial called MS-SPI…

The Partners Multiple Sclerosis Center at Brigham and Women’s Hospital has joined BrainStorm Cell Therapeutics in a Phase 2 trial exploring the safety and efficacy of NurOwn in the treatment of progressive multiple sclerosis (MS). This is the fifth and final clinical site participating in…

Janssen has submitted an application to the European Medicines Agency (EMA) asking that ponesimod be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets the sphingosine-1-phosphate receptor…

In this column, I’ll be highlighting some of the research presented at this year’s Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held last week in West Palm Beach, Florida. #ACTRIMS2020 — Remyelination in Adult Animal Brains Possible via Cell Transplant, Study Says You’ll need…

Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…

AB Science‘s masitinib significantly slowed disability progression in people with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive MS (SPMS) at a lower dose of 4.5 mg/kg a day, top-line results from a Phase 2b/3 clinical trial show. Masitinib, formerly known as AB1010, is an oral…

Clene Nanomedicine‘s remyelination therapy candidate, CNM-Au8, showed a “robust” ability to stimulate the production of new myelin and increase the number of myelin-wrapped nerve fibers in the brain and spinal cord of animals in models of demyelinating disease, allowing mice to recover motor skills, a study reports.

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint — a significant reduction in the number of new lesions visible on a brain imaging scan — in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…

Transplanting patients’ own mesenchymal stem cells (MSCs) is a safe therapeutic approach and can delay disease progression in people with multiple sclerosis (MS), a meta-analysis review shows. The study also showed that cells transplanted to the spinal cord (intrathecal injection) were associated with significantly slower disease progression rates, compared…

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…

A new study has found a link between the amount of fat in the blood and changes to the arteries surrounding the necks and skulls of people with multiple sclerosis (MS). The finding was described in the study “Lipoprotein(a) Levels Are Associated with the…

Recovering well after a first relapse and starting a disease-modifying therapy (DMT) immediately afterward considerably increases the likelihood of slowing progression in multiple sclerosis (MS), a study suggests. Its findings support relapse recovery as a critical factor for DMT initiation, and one that should be assessed routinely in MS…

Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing — facial redness, itching or rash — in patients with relapsing-remitting multiple sclerosis (RRMS). Flushing is a common side effect of an oral MS therapy called…

A blood-cleansing process known as immunoadsorption appears to be superior to plasma exchange in treating relapses that don’t respond to conventional steroid therapy in people with multiple sclerosis (MS) or clinically isolated syndrome (CIS), a study reports. These findings were reported in “Safety and efficacy of immunoadsorption…

A single dose of CD45-ADC, an investigational targeted therapy being developed to treat different types of autoimmune diseases, is enough to reset the normal function of the body’s immune system in a mouse model of multiple sclerosis (MS), and to delay onset of the disease. Those findings…

Long-term treatment with interferon beta (IFN-beta) corrects the defective immune balance characteristic of people with relapsing-remitting multiple sclerosis (RRMS), a study has found. The study also identified more than 200 genes with significantly different activity between complete and partial responders to IFN-beta treatment, which could be used to identify which…

Acthar Gel (repository corticotropin injection) is more effective for treating flares in multiple sclerosis (MS) than other alternatives, including intravenous immunoglobulin or plasmapheresis, a claims-based study from Mallinckrodt Pharmaceuticals reports. The study “Treatment Effectiveness for Resolution of Multiple Sclerosis…

Vumerity Approved in US as Treatment for RRMS and Active SPMS By my count, Vumerity is the 18th disease-modifying therapy (DMT) that the U.S. Food and Drug Administration (FDA) has approved for multiple sclerosis (MS). It’s one of very few approved for secondary progressive MS (SPMS). I find…

Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…

A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…

The volume of atrophied (shrunken) regions in the brain, as visible through magnetic resonance imaging (MRI) scans, can predict disease progression in people with multiple sclerosis (MS), new research reveals. The finding was published in the journal Radiology in an article titled, “Atrophied Brain T2 Lesion Volume…

People with progressive forms of multiple sclerosis (MS) and past exposure to the Epstein-Barr virus are responding to a potential immunotherapy known as ATA188, tolerating the treatment well and with signs that suggest effectiveness, early updated data from an ongoing Phase 1 trial show. The research, “…

Monthly under-the-skin injections of ofatumumab are superior to Aubagio (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…