The Patient-Centered Outcomes Research Institute (PCORI) has awarded the Cleveland Clinic $6.7 million to identify optimal treatment strategies for people with relapsing-remitting multiple sclerosis (RRMS). The funds will support the extension study of the multicenter DELIVER-MS (NCT03535298) clinical trial. The study is comparing two MS treatment approaches…
clinical trials
Bionxt Solutions is getting ready to launch a pilot clinical trial to test BNT23001, its sublingual (under-the-tongue) version of cladribine to treat multiple sclerosis (MS). The treatment would be an alternative to Mavenclad, the approved tablet form of cladribine. Bionxt‘s thin-film formulation quickly dissolves under the tongue,…
A single 600 mg dose of Briumvi (ublituximab-xiiy) — instead of the approved 150 mg initial dose plus a 450 mg dose two weeks later — was well tolerated by adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from the ENHANCE Phase…
Kyverna Therapeutics’ CAR T-cell therapy candidate KYV-101 was deemed safe and well tolerated, and showed preliminary signs of efficacy, in people with progressive forms of multiple sclerosis (MS) in clinical testing. That’s according to data from two investigator-initiated Phase 1 trials, which enrolled individuals with secondary progressive…
Frexalimab, an experimental antibody-based medication, was well tolerated and maintained disease control over two years in adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from an open-label extension to a Phase 2 clinical trial (NCT04879628) in which frexalimab outperformed a placebo at reducing…
Clinical improvements in vision and cognition linked to the use of treatment candidate CNM-Au8 were correlated with signs of nerve cell repair and remyelination among people with relapsing-remitting multiple sclerosis (RRMS), according to new data. Remyelination is the process by which myelin, the fatty substance surrounding nerve cells…
Sanofi‘s oral BTK inhibitor tolebrutinib significantly delayed the onset of six-month confirmed disability progression compared with a placebo, by 31%, in people with nonrelapsing secondary progressive multiple sclerosis (SPMS). That’s according to recently published data from the HERCULES Phase 3 trial (NCT04411641), where the experimental therapy…
A Phase 4 observational study called ENABLE is enrolling adults with relapsing forms of multiple sclerosis (MS) across the U.S. to better understand the safety, tolerability, and efficacy of Briumvi (ublituximab-xiiy) in the real world. At least 500 patients are expected to enter ENABLE (NCT06433752) at some…
Quantum Biopharma is partnering with researchers at Massachusetts General Hospital in Boston on a clinical study to test a positron emission tomography (PET) tracer for monitoring changes in myelin content in people with multiple sclerosis (MS). The Phase 1 study (NCT04699747) is recruiting healthy adults and people…
No added benefit was found in increasing the dose of Genentech’s Ocrevus (ocrelizumab) — to two to three times the currently approved 600 mg dose — in slowing disability progression in adults with relapsing multiple sclerosis (MS), according to new data from a Phase 3 clinical study. The…
The AdventHealth Neuroscience Institute is recruiting patients for a Phase 1b clinical trial testing IDP-023, an off-the-shelf cell-based treatment that Indapta Therapeutics is developing for primary or nonactive secondary progressive multiple sclerosis (MS). The company delayed the study’s expected launch in the second half of last…
A multicenter Phase 2a clinical trial testing Tiziana Life Sciences’ foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has dosed the first patients enrolled at Yale MS Center. The Phase 2a study (NCT06292923) is assessing the treatment’s safety and efficacy against a placebo in…
In a new deal, TG Therapeutics will use MaxCyte’s engineering technology to develop and manufacture its off-the-shelf CAR T-cell therapy candidate azercabtagene zapreleucel — azer-cel for short — for adults with progressive forms of multiple sclerosis (MS). The experimental treatment is being advanced toward a Phase 1…
A Phase 2 clinical trial is currently recruiting adults with relapsing types of multiple sclerosis (MS) to investigate Zenas Biopharma’s experimental therapy obexelimab as a weekly subcutaneous, or under-the-skin, injection, the company has announced in a press release. The study, called MoonStone (NCT06564311), is open to…
A 14-week regimen of physical therapy combined with PoNS — a neurostimulator device used to improve mobility — led to significant gait improvements in people with multiple sclerosis (MS), with evidence that its benefits are sustained over time, according to new data from the real-world PoNSTEP clinical study.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has cleared Pheno Therapeutics to initiate a first-in-human Phase 1 clinical trial to test its oral candidate PTD802 in healthy volunteers. The therapy is a selective small molecule antagonist, or inhibitor, of the GPR17 receptor and is designed to restore…
TG Therapeutics is working to develop a subcutaneous, or under-the-skin, version of Briumvi (ublituximab-xiiy), its approved therapy for relapsing forms of multiple sclerosis (MS). The company said it plans to start a pivotal clinical program this year which could support an application seeking approval of the…
Cabaletta Bio is getting set to launch a clinical trial testing its cell therapy resecabtagene autoleucel (rese-cel) in people with relapsing and progressive forms of multiple sclerosis (MS). The company sought permission last year from the U.S. Food and Drug Administration (FDA) to start the study. Once such…
Patient enrollment has been completed ahead of schedule in a Phase 2 clinical trial evaluating Contineum Therapeutics‘ PIPE-307, an oral therapy aiming to restore myelin — a process known as remyelination — in people with relapsing-remitting multiple sclerosis (RRMS), the company announced. The VISTA trial (NCT06083753), launched…
A Phase 1 clinical trial that is investigating a new vaccine against the Epstein-Barr virus (EBV), a well-established risk factor for developing multiple sclerosis (MS), in healthy volunteers has dosed its first participant. The vaccine, called MDX2201, is being developed by Modex Therapeutics, an Opko Health company,…
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,…
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