clinical trials

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…

Nearly one year of treatment with frexalimab, an antibody being developed by Sanofi, significantly reduced the blood levels of neurofilament light chain (NfL), a biomarker of nerve cell damage that typically is elevated in people with multiple sclerosis (MS). That’s according to new data from a company-sponsored…

The U.S Food and Drug Administration (FDA) authorized an investigational new drug application from Synaptogenix, clearing the company to launch a clinical trial to test whether its lead candidate bryostatin-1 can prevent cognitive decline in people with multiple sclerosis (MS). The open-label, Phase 1 clinical trial (NCT06190912),…

A three month cognitive rehabilitation program, with or without aerobic exercise, increased tissue volume and activity in brain regions linked to cognition among people with progressive forms of multiple sclerosis (MS), clinical trial data suggests. The MRI findings offer potential biological explanations about why cognitive rehabilitation leads to cognitive…

A large clinical trial to test online programs for treating fatigue in people with multiple sclerosis (MS) will launch in the U.S. in the coming months. The study — the largest of its kind — will be funded by a nearly $4.5-million grant from the U.S. Department of…

Charles River Laboratories has joined up with FibroBiologics to manufacture the company’s spheroids for clinical trials in multiple sclerosis (MS) and several other conditions. The spheroids are groups of fibroblast cells arranged in a three-dimensional (3D) structure that more closely resemble how cells organize in living tissues.

A lower dose of the experimental oral therapy vidofludimus calcium (IMU-838) was not as effective as higher doses at reducing lesions in people with relapsing-remitting multiple sclerosis (RRMS), extended data from the therapy’s Phase 2 EMPhASIS trial show. “We found that doses of 30 mg and 45 mg,…

Fully 70% of patients with nonactive secondary progressive multiple sclerosis (SPMS) who received foralumab nasal spray in an expanded access program (EAP) experienced a lessening in fatigue levels after six months of treatment. That’s according to early findings from the EAP — a program that enables patients with serious…

Two years of treatment with Briumvi (ublituximab) in clinical trials resulted in a confirmed reduction in disability for more than 1 in 10 people with early relapsing multiple sclerosis (MS) who had not received any prior treatment. That’s according to new data from the ULTIMATE Phase 3 trials,…

Long-term treatment with Clene Nanomedicine‘s experimental oral therapy CNM-Au8 led to signs of sustained improvements in nerve and myelin health for people with relapsing-remitting multiple sclerosis (RRMS) over three years, according to new data from the VISIONARY-MS clinical trial. The findings continue to support Clene’s plans to…

Ocrevus (ocrelizumab) had similar benefits in Black and Hispanic multiple sclerosis (MS) patients as earlier clinical trials with white patients did, one-year data from the CHIMES clinical trial indicates. About half of the CHIMES participants achieved no evidence of disease activity, or NEDA, which is defined as the…