Trial results

A Phase 2 clinical trial into the safety and tolerability of higher-dose temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer, GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…

Tecfidera (dimethyl fumarate) appears to have similar benefits to Gilenya (fingolimod) in preventing relapses and the loss of motor function and cognition in people with multiple sclerosis (MS), a study with real-world data found. The two medications also led to similar findings on MRI scans, including in…

Acthar Gel (repository corticotropin injection) may be useful for managing disease relapses in people with relapsing-remitting multiple sclerosis (RRMS) who fail to respond to treatment with corticosteroids, according to results from a small clinical trial. The study, “Results from a multicenter, randomized, double-blind, placebo-controlled study…

Ocrevus (ocrelizumab) may be more effective than Gilenya (fingolimod) at preventing relapse in relapsing-remitting multiple sclerosis (RRMS) patients who recently transitioned from Tysabri (natalizumab), according to a new study. Ocrevus is “potentially a better exit strategy than [Gilenya] after [Tysabri] cessation, with an impressive reduction [in] risk…

The French Health Authority has approved AB Science’s request to launch a Phase 3 clinical trial to confirm the safety and effectiveness of its lead candidate masitinib in adults with primary progressive multiple sclerosis (PPMS) and nonactive secondary progressive MS (SPMS). “We are very excited to initiate…

MS-STAT2, a clinical trial testing whether the cholesterol-lowering medication simvastatin might slow disability progression in secondary progressive multiple sclerosis (SPMS), has finished enrollment. A total of 964 people are now in the trial (NCT03387670), making it the largest progressive MS trial not run by a commercial…

Treatment with a newly discovered subset of regulatory B-cells (Bregs) — a type of immune cell that dampens immune responses — significantly reduced symptoms in a mouse model of multiple sclerosis (MS), a study shows. Similar effects were observed in a mouse model of uveitis, an inflammatory eye disease triggered…

A new subset of type 3 innate lymphoid cells (ILC3s) — a type of immune cell known mostly for its anti-inflammatory and immunosuppressive effects in the gut — infiltrates the brain and promotes the abnormal immune attacks that drive multiple sclerosis (MS), according to a study in a mouse model…

Taking the hormone melatonin may increase overall sleep quality in people with multiple sclerosis (MS), a clinical trial found. The compound, available as an over-the-counter dietary supplement, was particularly effective at extending sleep time in patients. Of note, sleep time decreased with age, meaning that “younger participants may have…

Aubagio (teriflunomide) failed to significantly reduce relapses in children with multiple sclerosis (MS), but two years of treatment decreased the number of brain lesions on MRI scans, according to the final results of the Phase 3 TERIKIDS clinical trial. Importantly, the lack of a signficantly lower relapse rate…

People in a Neural Sleeve gait study were reported to show an “average improvement” of 143% in foot drop, a common symptom of multiple sclerosis (MS) and other conditions that hinder mobility, its developer, Cionic, reports. The wearable “bionic” device — which analyzes, predicts,…

Into-the-vein treatment with mesenchymal stem cells (MSCs) failed to significantly reduce brain inflammation or improve clinical conditions among adults with active multiple sclerosis (MS) in an international Phase 2 clinical trial, according to final study data. The trial, which used magnetic resonance imaging (MRI) scans to assess…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13–15. Go here to see the latest stories from the conference.

Increasing the activity of a gene called Myc can make oligodendrocyte precursor cells, or the cells that repair myelin, more efficient — “ground-breaking research” that could have implications for advancing MS treatments, according to a new study by Cambridge researchers. The study, “Myc determines the functional age…

TG Therapeutics  has applied to the U.S. Food and Drug Administration (FDA) for approval of ublituximab, the company’s investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…

The therapeutic administration of mesenchymal stem cells can improve functional abilities and promote the restoration of lost myelin in rodent models of multiple sclerosis (MS), according to a new analysis of published studies. The findings highlight the potential of these stem cells, but also point to a need for…

  An extended-release formulation of amantadine, ADS-5102 was significantly more effective than a placebo at increasing walking speed in multiple sclerosis (MS) patients who had difficulty with this, particularly younger patients with a shorter disease course, the INROADS Phase 3 trial demonstrated. Further clinical work on this investigative…

Getting the Pfizer-BioNTech vaccine for COVID-19 does not increase the risk of multiple sclerosis (MS) relapses in the two months following vaccination, according to a new study. The results support recommending COVID-19 vaccines for people with MS, its researchers said. “The incidence of relapses in the 2 months before and…

Sonoma Biotherapeutics has raised $265 million in investment funding to support the development and production of novel immune T-cell therapies to treat severe autoimmune and inflammatory diseases, such as multiple sclerosis (MS). “We are ushering in a new era of medicine, using immune cells as living therapies that…

Clene’s investigational oral therapy CNM-Au8 improved energy metabolism in the brain of adults with relapsing-remitting multiple sclerosis (RRMS), according to top-line results from the REPAIR-MS trial. This open-label Phase 2 pilot study (NCT03993171), taking place in Texas, is running in parallel with REPAIR-PD, another Phase 2…

Removing an ion channel called Piezo1 from immune T-cells lessened disease severity in a mouse model of multiple sclerosis (MS), a study showed. Notably, these beneficial effects were associated with an expansion of regulatory T-cells (Tregs) — a type of immune cell that typically dampens immune and inflammatory responses —…

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…

Tecfidera has a lower risk of discontinuation due to treatment failure than Aubagio in people with multiple sclerosis (MS), a new observational study in Norway suggests. In the study, people receiving Tecfidera (dimethyl fumarate) were 38% less likely to experience treatment failure and stop use than those receiving…

High-potency therapies are more effective at reducing the frequency of symptom relapses in people with secondary progressive multiple sclerosis (SPMS) than low-potency medications, a 10-year study showed. Notably, there was no difference in the effectiveness of either high- or low-potency medicines to limit the progression of disability. “When the…

Could a cannabis spray be just what the doctor ordered to treat our MS symptoms? I’m talking about Sativex (nabiximols), which has been developed as a treatment for moderate and severe MS spasticity. Sativex combines THC, the chef intoxicant in marijuana, with CBD, marijuana’s nonpsychoactive component. It’s sprayed…

The Multiple Sclerosis Society of Canada has granted its International Progressive MS Alliance (Alliance) Research Challenge Awards to 19 researchers for their work on progressive forms of multiple sclerosis (MS). Among them is Jennifer Gommerman, PhD, a professor at the University of Toronto, in Canada, who will use…

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…

A computer-based training program that exercises distinct components of attention and working memory can improve cognition in young people with pediatric-onset multiple sclerosis (POMS), a new study indicates. Findings also support a common pencil-and-paper measure of cognition, called the Symbol Digit Modalities Test (SDMT), in detecting clinically meaningful changes…

Nasal Foralumab Led to Promising Immune Effects in Phase 1 Trial It sure would be nice to have a nasal spray to treat MS, but this research is still in its early stages. This study looked only at the safety and preliminary effectiveness of nasal foralumab on healthy volunteers.