clinical trials

High-dose biotin aided walking speed in people with progressive multiple sclerosis after 12 to 15 months as an add-on treatment, an analysis of placebo-controlled clinical trials shows. However, the therapy failed to improve other measures of disability, and was associated with inaccurate lab test results caused by high levels…

The low-fat Swank diet and the Wahls elimination diet reduced fatigue and improved quality of life after three months for people with relapsing-remitting multiple sclerosis (RRMS), a clinical trial has found. “It’s encouraging that fatigue was reduced and quality of life improved in both groups,” Bruce Bebo, PhD, from…

Tysabri (natalizumab) given every six weeks was as safe and effective over nearly 1.5 years of use as its approved four-week dosing in people with relapsing-remitting multiple sclerosis (RRMS), according to top-line data from the Phase 3b NOVA study. Tysabri is typically administered every four weeks, or about…

Larger declines with treatment in blood levels of neurofilament light chain (NfL), a marker of nerve cell damage, are associated with fewer brain lesions, less brain shrinkage, and lower relapse rates in people with relapsing forms of multiple sclerosis (MS), a study reported. These results, based on a post-hoc analysis…

The U.S. Food and Drug Administration (FDA) has given the green light to a Phase 2 clinical trial that will assess the efficacy of using adult mesenchymal stem cells (MSCs) to treat the symptoms of mild to moderate multiple sclerosis (MS). The non-profit Hope Biosciences Stem Cell Research Foundation (HBSCRF),…

Low doses selected and underlying inflammatory disease may have confounded the ability of temelimab to significantly affect neuroinflammation in a Phase 2 trial in relapsing-remitting multiple sclerosis (RRMS) patients. GeNeuro‘s investigational MS therapy did, however, show other evidence of clinical benefit that supports its continued development, researchers…

Biogen Strikes Deal for Orelabrutinib, Now in Phase 2 Trial BTK inhibitors, such as orelabrutinib, are designed to selectively block the activity of an enzyme important for the activation of B-cells and microglia. Some of those cells drive the abnormal immune responses that attack the central nervous systems of…

NervGen Pharma announced the formation of its multiple sclerosis (MS) clinical advisory board, a group of experts who will work with the company as it prepares to start a Phase 2 clinical trial next year testing its lead compound, NVG-291, in people with MS. “We are honored to…

Biogen has signed a deal with InnoCare Pharma to acquire global commercialization and licensing rights to orelabrutinib, an experimental oral BTK inhibitor (BTKi) now being tested in people with relapsing-remitting multiple sclerosis (RRMS) in a Phase 2 clinical trial. Under the terms of the agreement, Biogen will have…

The U.S. Food and Drug Administration has cleared Immunic Therapeutics to initiate two clinical trials of its investigational medication IMU-838 (vidofludimus calcium) in people with relapsing-remitting multiple sclerosis (RRMS), as well as a separate trial for people with progressive types of MS. The RRMS clinical trial program, expected…

In clinical trials, the investigational anti-CD20 therapy ublituximab was the first to push the annualized relapse rate (ARR) below the 0.1 threshold among patients with relapsing forms of multiple sclerosis (MS), while improving disability outcomes in a significant proportion of patients. “The [relapse] rate was below a tenth…

Abata Therapeutics has opened with $95 million in financing, and plans to use regulatory T-cells to treat autoimmune and inflammatory diseases, starting with progressive forms of multiple sclerosis (MS). Money raised will be used to support work for three clinical trials it plans to initiate in 2025, including…

Long-term use of Kesimpta (ofatumumab) among people with multiple sclerosis (MS) did not substantially lower their antibody levels, allowing them to retain an ability to fight infections, new data from a Phase 3 clinical trial indicate. “These long-term results continue to support Kesimpta as a high-efficacy, first-choice treatment with…

In the OPTIMUM clinical trial, Ponvory (ponesimod) significantly outperformed Aubagio (teriflunomide) in reducing relapse rates, fatigue, and evidence of brain damage among people with relapsing multiple sclerosis (MS). Based on these results, Ponvory has now been approved in the U.S. and the European Union as a treatment…

In the past year, BrainStorm Cell Therapeutics was granted four patents and is waiting for a fifth, already accepted, meant to provide protection for its NurOwn cell therapy and technology in territories around the world. NurOwn is being tested in clinical trials as a potential treatment for…

Stem Cell Transplant Trial Enrolls First Patient in Minnesota It looks as if we’re moving closer to the day when stem cell transplants become an approved MS treatment in the U.S., at least I hope so. A trial is enrolling subjects to test the stem cells against several…

A clinical trial investigating patient-derived stem cell transplants for the treatment of people with severe relapsing forms of multiple sclerosis (MS) has enrolled a patient in Minnesota. The patient was enrolled at the University of Minnesota Medical School, one of two trial sites in the state. An additional 18…

Gilenya (fingolimod) at its approved 0.5 mg daily dose continues to be the optimal dose for people with relapsing-remitting MS (RRMS), a systematic review of 11 clinical trials confirmed. A 0.25 mg/day dose, however, also showed improvement over placebo in MRI outcomes and patient satisfaction, the researchers noted, and further…

Nasally-administered foralumab, a potential treatment for neurodegenerative disorders such as progressive forms of multiple sclerosis (MS), appears safe and well-tolerated, and shows immune-modulating and anti-inflammatory effects in healthy volunteers, an updated analysis from a Phase 1 trial has found. “Nasal administration of Foralumab is a unique approach to treat…

Foralumab, an investigational anti-CD3 antibody that is administered via a nasal spray, has been given for the first time to a person with secondary progressive multiple sclerosis (SPMS). It was administered under an Individual Patient Expanded Access Program, which earned approval from the U.S. Food and Drug Administration in…

The digital therapeutics company MedRhythms is launching a clinical trial to evaluate the safety and efficacy of MR-004, an experimental product that uses rhythmic sounds to improve walking abilities in people with multiple sclerosis (MS). The randomized…

Perceptions of a medication can predict treatment adherence and persistence — sticking with the same therapy — in people with multiple sclerosis (MS), a prospective observational study found. The findings were the result of a clinical study (NCT02488343) evaluating the profile of adherence to therapy in patients ages…

Therini Bio announced raising $17 million in a financing round to speed the development of an antibody that might treat people with inflammatory conditions, such as multiple sclerosis (MS), associated with damage to blood vessels. These funds will also support work aiming to move this antibody, targeting the protein…

Although multiple sclerosis (MS) affects many different races and ethnicities and may even be more aggressive in some of these patient populations, minority representation in MS clinical trials remains critically low. Black patients made up only a fraction of the total enrollment in large-scale Phase 3 trials for three…

Phase 4 Trial Will Test if Ocrevus Can Prevent MS Onset in RIS Patients Yes, you’re reading this right. This trial aims to see if Ocrevus can stop MS before it’s officially diagnosed — when it may be smoldering and presenting a minimum of MS-like activity. In July, this…

Yale University is launching CELLO, a multicenter study to investigate the efficacy of Ocrevus (ocrelizumab) in treating people with lesions suggestive of multiple sclerosis (MS), a condition known as radiologically isolated syndrome. The Phase 4 study (NCT04877457) aims to evaluate whether short-term treatment with Ocrevus can…

Two global Phase 3 clinical trials comparing fenebrutinib, an investigational oral BTK inhibitor by Roche, with Aubagio (teriflunomide) are now enrolling adults with relapsing forms of multiple sclerosis (MS), the National MS Society announced in a press release. The twin studies, called FENhance 1 (NCT04586023)…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Vumerity (diroximel fumarate) continues to be safe and well-tolerated, in addition to reducing measures of disease activity in people…

The multiple sclerosis (MS) treatment Gilenya (fingolimod) is associated with a 16% greater risk of infections, compared with a placebo or control treatment, according to data from 12 randomized clinical trials. The findings were published in a study, “Incidence and Risk of Infection Associated With Fingolimod in Patients…

Interim data from a Phase 2 trial of Immunic Therapeutics’ investigational oral therapy IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS) patients has established a once-daily, 30 mg dose as the most appropriate for future Phase 3 trials. The…