clinical trials

Immunic Therapeutics says it remains “on track” in testing its multiple sclerosis treatment candidate vidofludimus calcium in twin Phase 3 clinical trials with people who have relapsing disease — and in the Phase 2 CALLIPER study involving those with progressive forms of MS. Indeed, in a new company…

OCS-05, an experimental medication that Oculis is developing to treat acute optic neuritis, a common symptom of multiple sclerosis (MS) that can lead to vision loss, was well tolerated and improved measures of vision and eye health in a Phase 2 clinical trial. The ACUITY study (NCT04762017) included…

Treatment with Tecfidera (dimethyl fumarate) significantly reduces relapse rates for people with multiple sclerosis (MS), and most MS patients on the approved therapy remain free from disability progression for several years. That’s according to a final analysis from the Phase 4 ESTEEM clinical trial (NCT02047097), which tracked…

The team at Multiple Sclerosis News Today has brought our audience the latest news about treatments, scientific research, and clinical trials in multiple sclerosis (MS) throughout 2024. Here is a list of the top 10 most-read articles we published this year. We look forward to continuing to serve…

IMP761, an experimental immunotherapy Immutep is developing for multiple sclerosis (MS) and other autoimmune conditions, has shown a promising safety profile in an ongoing Phase 1 clinical trial  in healthy volunteers, with no treatment-related side effects reported to date, the company said. The first-in-human Phase 1 trial…

Bionxt Solutions is preparing to launch a pilot clinical trial to compare BNT23001, its new sublingual, or under-the-tongue, formulation of cladribine, to the original medication Mavenclad to treat multiple sclerosis (MS). Mavenclad is a tablet formulation of cladribine that’s approved for adults with relapsing forms of MS. The…

Tiziana Life Sciences is expanding its Phase 2 clinical trial testing foralumab nasal spray for the treatment of nonactive secondary progressive multiple sclerosis (SPMS), with six additional clinical sites across the northeastern region of the U.S. The new sites, all at top U.S. institutions, bring together leaders in…

LPX-TI641, Lapix Therapeutics‘ experimental oral therapy to restore immune system balance in people with multiple sclerosis (MS) and other autoimmune diseases, was found safe and well tolerated at all doses tested in healthy adults. That’s according to top-line data from a Phase 1 trial (NCT05853835), which…

An artificial intelligence (AI)-based tool called Muse aims to accelerate drug development by optimizing clinical trial patient recruitment. The tool, designed as part of a collaboration among Formation Bio, OpenAI, and Sanofi, is designed to be implemented across a range of areas. Sanofi will first put it…

A mesenchymal stem cell therapy led to significant improvements in quality-of-life scores for people with multiple sclerosis (MS) in a small clinical trial, according to the treatment’s developer Hope Biosciences Research Foundation (HBRF). “The results of this trial are groundbreaking for multiple sclerosis,” Donna Chang, president of HBRF,…

A first group of healthy adults has been dosed in a Phase 1 safety and tolerability trial of Lucid-21-302, a potential myelin-protective oral treatment for multiple sclerosis (MS), regardless of disease type. These initial volunteers will serve as the trial’s sentinels, an occasional study feature allowing for a…

An independent data monitoring committee has recommended that the twin ENSURE Phase 3 trials testing vidofludimus calcium in people with relapsing forms of multiple sclerosis (MS) continue as planned without adjustments. The opinion that the trials are worth continuing was based on a review of interim, unblinded trial…

Sanofi has ended a Phase 2 clinical trial into oditrasertib, an investigational RIPK1 inhibitor therapy, in people with relapsing and progressive multiple sclerosis (MS) after it failed to meet its goals. The study, which had started dosing early last year, failed to show that oditrasertib significantly lowered…

SetPoint Medical is planning to launch a clinical trial next year to investigate its nerve stimulator device, intending to support myelin repair, in people with relapsing-remitting multiple sclerosis (RRMS). The announcement comes after U.S. Food and Drug Administration (FDA) approval of an investigational device exemption, allowing the…

Acupuncture may be a promising complementary approach for easing fatigue and improving quality of life for people with multiple sclerosis (MS), according to a small review study and meta-analysis. Still, the study highlighted a need for future clinical trials that use more standardized acupuncture approaches, according to the researchers,…

Daily treatment with high-dose simvastatin, a widely used cholesterol-lowering medication, failed to slow disability progression in adults with secondary progressive disease or SPMS, according to top-line data from a Phase 3 clinical study. Jeremy Chataway, PhD, a professor of neurology at University College London (UCL) in the U.K.,…

Sanofi’s tolebrutinib significantly delayed disability progression, by 31%, and increased the rates of disability improvement compared with a placebo in people with nonrelapsing secondary progressive multiple sclerosis (SPMS), according to new data from the HERCULES Phase 3 clinical trial. The investigational BTK inhibitor also was found to significantly…

A year of treatment with the experimental BTK inhibitor fenebrutinib was safe and nearly entirely suppressed signs of disease activity, including relapses, disability progression, and brain lesions, in people with relapsing forms of multiple sclerosis (MS), according to new data from the open-label extension part of a Phase…

Treatment with the investigational BTK inhibitor tolebrutinib significantly delayed the onset of confirmed disability progression in people with nonrelapsing secondary progressive multiple sclerosis (SPMS) compared with a placebo, meeting the primary goal of the HERCULES Phase 3 trial. A preliminary analysis of liver safety was consistent with previous…

The U.S. Food and Drug Administration (FDA) has given the green light to Immpact Bio to conduct a Phase 1 clinical trial to test IMPT-514, its experimental cell therapy, in people with multiple sclerosis (MS). With the investigational new drug (IND) clearance by the FDA, Immpact Bio now…

A potential treatment of relapsing-remitting multiple sclerosis (RRMS), arsenic trioxide (ATO) has been patented in the European Union based on findings in preclinical studies. Notice of an intent to grant patent EP18722530, titled “Method for treating relapsing-remitting multiple sclerosis using arsenic trioxide,” was given by the European Patent…

A Phase 1 clinical trial that’s testing IMP761, an experimental treatment for multiple sclerosis (MS) and other autoimmune conditions, has dosed its first healthy participant, the therapy’s developer has announced. Immutep received regulatory clearance to start the first-in-human trial of IMP761 in the Netherlands about a…

TG Therapeutics plans to soon launch a Phase 1 clinical trial to investigate the CAR T-cell therapy azercabtagene zapreleucel, or azer-cel, in people with progressive forms of multiple sclerosis (MS). The announcement comes after the U.S. Food and Drug Administration (FDA) cleared TG’s…

Indapta Therapeutics will launch a Phase 1 clinical trial in the U.S. in the second half of 2024 to explore its cell-based therapy IDP-023 in people with progressive forms of multiple sclerosis (MS). The announcement follows the U.S. Food and Drug Administration’s (FDA) clearance of the company’s investigational…

Iaso Biotherapeutics has received the green light from the U.S. Food and Drug Administration (FDA) to start clinical trials of its investigational CAR T-cell therapy equecabtagene autoleucel (eque-cel) in people with multiple sclerosis (MS). The FDA’s clearance of the company’s investigational new drug (IND) application makes MS the…

Kesimpta (ofatumumab) is more effective than Aubagio (teriflunomide) among people with multiple sclerosis (MS) from ethnically diverse groups, including Black and African American, Hispanic and Latino, and Asian individuals, according to an analysis of pooled clinical trial data. “Determining whether there are differences in how people respond…

Immutep has been cleared to start a Phase 1 clinical trial in the Netherlands to test IMP761, its experimental antibody therapy for autoimmune diseases such as multiple sclerosis (MS), in healthy volunteers. The first-in-human Phase 1 clinical trial seeks to assess the safety and pharmacological properties of IMP761.

Treatment with modafinil, a stimulant approved in the U.S. for treating certain sleep-related disorders, significantly reduced fatigue and improved overall quality of life when used in clinical trials for people with multiple sclerosis (MS), according to a review of published study data. However, its use was linked to a…

People with multiple sclerosis (MS) tend to experience a short-term reduction in disability and brain lesion volume after receiving stem cell therapy, according to a meta-analysis of nine studies detailing randomized clinical trials. After six and 12 months, however, the researchers found no differences in disability between patients…

Abata Therapeutics is expected to launch a Phase 1 clinical trial by the end of the year to test ABA-101, its experimental therapy for progressive multiple sclerosis (MS), after getting a green light from the U.S. Food and Drug Administration (FDA). The FDA approved Abata’s investigational new drug…