Note: This story was updated March 6, 2025, to clarify the specific disability measures and results assessed in each trial. Sanofi’s experimental BTK inhibitor tolebrutinib may be more effective at reducing the risk of disability accumulation in people with multiple sclerosis (MS) who have evidence of paramagnetic…
ACTRIMS
A new model that combines genetic and symptom-based risk scores to predict the development of multiple sclerosis (MS) could help to accelerate the disease’s diagnosis, and allow patients to receive earlier treatment, a team of U.S. researchers noted in a study. In a presentation detailing this work at this…
Proposed revisions to the McDonald criteria, a set of diagnostic guidelines for multiple sclerosis (MS), may help diagnose people who could have been missed under earlier versions, according to a recent analysis. That includes people with radiological-only onset, when there are signs of disease on MRI scans but…
Note: This study was updated March 3, 2025, to correct that a ketogenic diet is a low-carbohydrate, high-fat diet. Eating a version of the low-carbohydrate, high-fat ketogenic diet for six months led to an anti-inflammatory shift in immune cell populations among people with stable, relapsing-remitting multiple sclerosis (RRMS)…
Treatment with Ocrevus (ocrelizumab) may have a beneficial effect on paramagnetic rim lesions — known as PRL, these are a type of chronic inflammatory lesion — in people with multiple sclerosis (MS), according to a newly shared analysis. PRLs, a form of nerve damage seen in MS, have…
Immune cells from people with multiple sclerosis (MS) exhibit distinct gene activity just before patients have a disease relapse, according to recent research. The observed immune perturbations, which are no longer observed by the time the relapse is actively underway, are consistent with the body’s response to a reactivation…
People with relapsing forms of multiple sclerosis (MS) being treated with an infusion CD20 inhibitor such as Ocrevus (ocrelizumab) can safely transition to the more recent Briumvi (ublituximab-xiiy), which is given in shorter infusion times. That’s according to data from the ENHANCE Phase 3b clinical trial…
The presence of paramagnetic rim lesions (PRLs), which represent areas of damage in the brain and spinal cord with chronic active inflammation, may help identify people with multiple sclerosis (MS) who are more likely to have cognitive decline over time. That’s according to four-year data presented by Hannah Schwartz,…
The antihistamine clemastine accelerated disease progression by more than five times in some adults with progressive multiple sclerosis (MS) who received it in a Phase 1/2 trial, new data show. Joanna Kocot, PhD, a neuroscientist at the National Institutes of Health (NIH), showed that this effect is at least…
Convelo Therapeutics is developing two experimental oral treatments to promote myelin repair in multiple sclerosis (MS) and both have shown promise in preclinical models. The company is in the final stages of safety studies in large animals. Once those studies are done, it plans to start studies that…
Nearly one year of treatment with tolebrutinib, an oral small molecule being developed by Sanofi, failed to eliminate iron rim lesions in adults with multiple sclerosis (MS), according to data from a small Phase 2 clinical trial. Researchers are continuing to examine study results to determine…
The experimental BTK inhibitor evobrutinib was no better than Aubagio (teriflunomide) at preventing relapses, reducing brain lesions, or slowing disability progression in people with relapsing forms of multiple sclerosis (MS), according to data from two Phase 3 trials. Both medications had generally similar safety profiles, although increases…
Repeated treatment with the mesenchymal stem cell therapy NG-01 led to gains in mobility and cognition, along with patient-reported quality of life, for most people with progressive multiple sclerosis (MS) in an extension study. Markers of nerve damage were also reduced, indicating significant nerve-protecting effects. Dimitrios Karussis, MD,…
Treatment with Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium (IMU-838) lowered the levels of a nerve damage marker in people with all subtypes of progressive multiple sclerosis (MS), including those without recent inflammatory activity. That’s according to an interim analysis of data from a Phase 2 study,…
About two-thirds of people with relapsing forms of multiple sclerosis (MS) remained completely free from relapses over six years of treatment with Zeposia (ozanimod) in the DAYBREAK clinical trial. Most also saw no sustained disability progression during that period and the mean number of new or enlarging lesions…
Supplements of indole 3-lactate (ILA), a molecule made by gut bacteria, significantly reduced disease severity and promoted myelin repair in mouse models of multiple sclerosis (MS). That’s according to new findings presented by Larissa Jank, PhD, a postdoctoral researcher at Johns Hopkins University, at the Americas Committee for Treatment…
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Novartis’ applications for ofatumumab — which has the…
Harvard professor and scientist Francisco Quintana, PhD, has been awarded the 2019 Barancik Prize for Innovation in MS Research for his work in understanding what causes multiple sclerosis (MS), and how to stop its development. Quintana has developed innovative research programs that use cutting-edge technology to help…
Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by a frequent reference made in our forums as well as in our columns and articles.
It is a question that multiple sclerosis (MS) patients, loved ones, and the larger community have asked for some time: “Will there be a cure for multiple sclerosis?” MS News Today had the opportunity to ask that question of leaders at the Americas Committee for Treatment and Research in…
Jeffrey Cohen, MD, director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, is the newly named president of ACTRIMS, the Americas Committee for Treatment and Research in Multiple Sclerosis. Cohen’s appointment concluded the 2019 ACTRIMS Forum that ran…
The Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) has awarded five young investigators for their research work on multiple sclerosis (MS). The awards were presented at the ACTRIMS Forum 2018, held Feb. 1-3 in San Diego,…
TG Therapeutics‘ ublituximab (TG-1101) led to a remarkable reduction in multiple sclerosis patients’ brain and spine lesions, a Phase 2 clinical trial showed. In fact, none of the treated patients had new gadolinium-enhancing lesions — or damaged nerve cell areas — six months after treatment, researchers said. Their analysis covered patients…
A University of Cambridge researcher, Robin Franklin, has been awarded the 2017 Barancik Prize for Innovation in MS Research for his work on myelin repair and as a potential way of treating multiple sclerosis (MS). Franklin is a senior scientist at the Wellcome Trust-MRC Cambridge Stem Cell…
Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28. The presentations will offer new insights into the therapy's mechanisms, safety and effectiveness in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities. MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease. The information Genentech plans to present will demonstrate "the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,” Dr. Sandra Horning, the company's chief medical officer and head of its Global Product Development arm, said in a press release. Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy's favorable benefit-risk profile, Genentech added. Two presentations will cover new ways that doctors can look for signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another is tracking slowly evolving lesions. Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials, whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients' disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients' disease. Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus' ability to treat primary progressive MS. It will look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevus’ safety — based on open-label extension studies — will be another component of the presentations. So far, researchers have detected no new safety issues. Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company's scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute — as opposed to chronic — disease activity. In addition to "two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,” Horning said. One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits. The research team believes the FLOODLIGHT method may be be able to detect subtle changes better. This could make it a better predictor of disease activity and long-term patient outcomes. In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS. The U.S. Food and Drug Administration approved Ocrevus in March 2017.
The 7th Joint ECTRIMS-ACTRIMS Meeting, the world’s largest annual international conference devoted to basic and clinical research in multiple sclerosis, will run from Oct. 25 to 28 in Paris — the city of Jean-Martin Charcot, the “Father of Neurology,” who provided the first detailed description of multiple sclerosis (MS)…
#MSParis2017 – Gilenya Reduces Relapses in Children and Adolescents with MS, Novartis Trial Shows
Gilenya decreased relapses in children and adolescents with multiple sclerosis in the phase 3 PARADIGMS trial, according to the therapy's developer, Novartis. The Swiss company will present the trial's results at the 7th Joint ECTRIMS-ACTRIMS meeting, set for Oct. 25-28 in Paris. The study addressed the safety and efficacy of an oral, once-daily dose of Gilenya in 215 MS patients aged 10 to 17. Participants received 0.5 mg or 0.25 mg of Gilenya, according to their body weight, and results were compared with those of intramuscular Avonex (interferon beta-1a given once weekly). The trial — conducted at 87 sites in 25 countries — was designed in partnership with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Pediatric Multiple Sclerosis Study Group. Gilenya led to a "clinically meaningful decrease in the number of relapses" over a period of up to two years, compared to Avonex, according to the trial. The safety results of Gilenya matched those observed in previous trials, with adverse events more likely among the Avonex group. Importantly, the PARADIGMS trial is the first-ever randomized, controlled Phase 3 study of a disease-modifying therapy in pediatric MS. No treatment is currently available for children and adolescents with MS. Novartis will now complete a thorough evaluation of the results and later submit Gilenya for approval by regulatory agencies. It will also extend the study to a five-year period.
TG Therapeutics will discuss ublituximab's ability to deplete B-cells linked to multiple sclerosis and to reduce inflammatory brain lesions at the 7th Joint ECTRIMS–ACTRIMS Meeting in Paris next month. The three presentations will cover preliminary results of a Phase 2 clinical trial of ublituximab's safety and effectiveness as a treatment for relapsing forms of MS, the company said in a press release. The conference will be Oct. 25-28. Dr. Amy E. Lovett-Racke of Ohio State University will discuss ublituximab's ability to decrease B-cells associated with MS after six months of treatment. Ublituximab is an antibody that targets B-cells carrying the CD20 protein on their cell surfaces. These cells are thought to play a role in MS development. Dr. Matilde Inglese of the Icahn School of Medicine at Mount Sinai in New York will discuss ublituximab's ability to decrease study participants' inflammatory brain lesions. And Dr. Edward Fox of Central Texas Neurology Consultants, the trial's principal investigator, will do a poster-session presentation on the study's patient characteristics and preliminary results as a whole, including safety. The ongoing Phase 2 trial is still recruiting patients with relapsing forms of MS. Researchers are randomly assigning participants to receive intravenous infusions of either ublituximab or a placebo. One of the study’s primary goals is to see how well ublituximab depletes B-cells 28 days after the start of treatment. Another primary goal is to see how safe the therapy is, with the measurement being treatment-related adverse events that patients experience over six months. Ublituximab’s ability to reduce relapses will be a secondary measure of the trial. Researchers will assess it after 48 weeks of treatment. Fox, who is the director of the Multiple Sclerosis Clinic of Central Texas, and a clinical assistant professor at the University of Texas Medical Branch in Round Rock, made a ublituximab presentation at the 3rd Congress of the European Academy of Neurology in June. It revealed that the therapy nearly depleted B-cells only four weeks after treatment started. Earlier data suggests that ublituximab can be administered in only one hour. Ocrevus, the only approved MS therapy that targets B-cells with CD20, requires 3 1/2 hours. Although the Phase 2 trial is continuing, the data generated so far supports plans for two Phase 3 trials, TG Therapeutics said. They will randomize patients to receive either ublituximab or Aubagio. The trials, which the company hopes to start by the end of September, will be conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. It allows the FDA to evaluate the design and population size of a trial a company intends to use to seek a drug's regulatory approval. The FDA has refused to approve therapies whose trial design it believed to be flawed. Obtaining a design sign-off before a trial improves the chance of a treatment being approved if it meets the study's objectives.
#MSParis2017 – MediciNova to Share Results of Ibudilast Trial in Progressive MS at October Summit
MediciNova will present data from its clinical trial of ibudilast (MN-166) in progressive multiple sclerosis (MS) at the upcoming 7th Joint ECTRIMS – ACTRIMS Meeting in Paris. The European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) selected the presentation “…
Atara Biotherapeutics recently published an update of the company’s quarterly financial results and operational highlights, including the advancement of its T-cell based immunotherapy strategies for multiple sclerosis (MS) and cancer. One of the investigational therapies featured in the report is ATA188, a potential treatment for MS.