clinical trials

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 new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS). At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms…

Trials testing new immunotherapies for multiple sclerosis (MS) should focus more on patients’ experiences and on symptoms relevant for them such as fatigue, depression, and cognitive difficulties, a German working group recommends. According to the team, which is working on developing new standards for planning MS trials, clinical…

Measuring the speed of signals sent to the brain by nerves in the eye could help assess if remyelination is taking place, a study in cats suggests. Such measurements could be useful in evaluating multiple sclerosis (MS) treatments aiming to repair myelin in clinical trials — of particular interest…

Mount Sinai Medical Center has joined with BrainStorm Cell Therapeutics to explore the safety and efficacy of NurOwn as a potential treatment for progressive multiple sclerosis (MS) in an ongoing Phase 2 trial. The New York center is the fourth clinical site participating in the trial, in addition…

GeNeuro is collaborating with clinical researchers at the Karolinska Institutet and the Academic Specialist Center (ASC) in Stockholm to open a new clinical trial of temelimab in people whose multiple sclerosis (MS) is progressing in the absence of relapses. Fredrik Piehl, MD, PhD, a professor of neurology at…

Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared to Tecfidera (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these two relapsing-remitting multiple sclerosis (RRMS) treatments show. These results were presented at the 27th Annual Meeting of the European Charcot Foundation,…

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…

MMJ International Holdings announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule — a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) — in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).

BrainStorm Cell Therapeutics received a $495,330 grant from the National Multiple Sclerosis (MS) Society  to support biomarker studies in its ongoing clinical trial testing the cell therapy NurOwn in patients with progressive multiple sclerosis (MS). NurOwn is a treatment based on the patients’ own bone marrow-derived mesenchymal stem…

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…

Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…

Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…

#ECTRIMS2019 – Are Injectables Inappropriate for Active Relapsing MS Treatment? Injectable disease-modifying therapies (DMTs) have been around for a long time. I took part in a Phase 3 clinical trial for Avonex (interferon beta-1a) in the mid-1990s. These treatments were the only game in town back then, and…

The National Multiple Sclerosis Society awarded more than $339,000 to Clene Nanomedicine to support clinical tests into its lead candidate CNM-Au8 in treating multiple sclerosis (MS) by protecting nerve cells and restoring myelin. The grant was awarded under the National MS Society’s Fast Forward program, which aims…

Ofatumumab, an investigational B-cell therapy being developed by Novartis, demonstrated encouraging results in lowering relapse rates and active brain lesions in people with relapsing multiple sclerosis (MS) enrolled in the ASCLEPIOS trials. For Stephen L. Hauser, MD, an investigator in the ASCLEPIOS trials, these results represent a…

Immunic Therapeutics announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapy for relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule. The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210…

FeetMe, a medical device company dedicated to the development of devices and digital health services to improve patients’ mobility, has raised €9.4 million ($10.25 million) in Series A funding to boost the commercialization of its innovative technology for clinical trials and regular clinical practice in hospitals and…

ExeGi Pharma announced a new clinical trial testing its probiotic Visbiome in people with multiple sclerosis (MS). The study will further evaluate whether changing bacteria in the gut could be therapeutically beneficial in MS. The human body hosts millions upon millions of bacterial guests, the majority of which…

EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinib in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is…

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, “…

Actelion‘s ponesimod, an investigational oral treatment, is superior to Sanofi‘s Aubagio (teriflunomide) in lessening the frequency of relapses and easing fatigue symptoms in adults with active, relapsing multiple sclerosis (MS), results of the OPTIMUM trial show. These data will lay the ground for submissions…

Mayzent (siponimod) reduces the risk of people with secondary progressive multiple sclerosis (SPMS) becoming dependent on a wheelchair, a new analysis of the EXPAND study shows. These findings further corroborate prior trial data demonstrating that Mayzent use delays disability progression and cognitive decline in SPMS patients. The results…

Oxcarbazepine, an anti-epileptic medicine, given in combination with a disease-modifying therapy (DMT) may help to stop disability progression in multiple sclerosis (MS) patients, results of Phase 2 trial suggest. Monica Marta, PhD, with Queen Mary University of London and Barts Health NHS Trust/The Royal London Hospital presented the data at the…

Richard Burt, MD, the chief of Northwestern Medicine’s immunotherapy for autoimmune diseases division, is taking a sabbatical, and the stem cell program he has headed for many years, which treated a number of people with MS, is shutting down. Burt headed a Phase 3 clinical trial…

Transplanting mesenchymal stem cells (MSCs) is safe and can delay disease progression in people with active, progressive multiple sclerosis (MS), according to results from a single-center clinical trial conducted in Israel. Six months after the transplant, a considerable proportion of patients showed no signs of disease activity, compared to…

Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning — unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, “…

Treatment with a potential remyelinating agent called liothyronine was safe and well-tolerated by people with multiple sclerosis (MS) in a Phase 1b trial. Preliminary results also suggested benefits in cognition, motor function, and fatigue. The study, “A Phase 1b, open-label study to evaluate the safety…

NervGen Pharma announced plans to open clinical trials evaluating the potential of its lead candidate NVG-291 to treat multiple sclerosis (MS) and spinal cord injury. NVG-291 is an investigational peptide that has shown an ability to stimulate nerve regeneration following an injury in several animal models of disease.

Oral ozanimod is more effective at reducing the frequency of relapses than Avonex (interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), and does so with reasonable safety, results of Phase 3 trial show. These findings were described in the study, “Safety and efficacy of ozanimod…