clinical trials

Fewer and less severe gastrointestinal (GI) side effects were evident in relapsing-remitting multiple sclerosis (RRMS) patients taking the investigational oral treatment Vumerity (diroximel fumarate) twice a day compared to those using Tecfidera (dimethyl fumarate), topline data from the EVOLVE-MS-2 trial show. Vumerity is a fumarate compound being developed…

Janssen has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal — a reduction in the…

The National Institutes of Health (NIH) awarded a $1.83 million grant to a Kessler Foundation researcher leading a clinical trial to test if a month-long cognitive training program can improve learning and memory in adults with multiple sclerosis (MS). Nancy Chiaravalloti, PhD, director of the Centers…

A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oral bioequivalent in treating relapsing forms of multiple sclerosis (MS), Banner Life Sciences…

Phase 3 Trial of Ibudilast Planned for SPMS Patients with Inactive Disease, MediciNova Says Though medications are approved in the U.S. to treat primary progressive multiple sclerosis and active secondary progressive MS (SPMS), no disease-modifying treatments are approved to treat the nonactive form of SPMS. This trial aims…

Treating people with relapsing forms of multiple sclerosis (MS) with opicinumab and Avonex (interferon beta-1a) for 72 weeks did not lead to a dose-dependent reduction in disability,  results of a Phase 2 trial show. However, an ongoing study is evaluating opicinumab in a subgroup with better clinical responses.

A Phase 3 trial is planned to confirm the safety and efficacy of oral ibudilast (MN-166) in treating people with secondary progressive multiple sclerosis (SPMS) without relapses, or those whose disease is not active, MediciNova announced. Data from this single Phase 3 study may be used to request…

A first group of healthy volunteers in a Phase 1 trial assessing the safety and tolerability of T20K, Cyxone‘s plant protein-derived candidate for the treatment of multiple sclerosis (MS), has been dosed in a study taking place in The Netherlands, the company announced. T20K is an investigational…

The Phase 2 clinical trial testing BrainStorm Cell Therapeutic’s investigational NurOwn therapy for progressive multiple sclerosis (MS) has added a third clinical site, the company announced. The trial (NCT03799718) now will enroll patients at the Keck School of Medicine of The University of Southern California (USC), and its academic…

EHP-101, a cannabidiol-based experimental therapy for multiple sclerosis, was able to recover myelin in damaged nerve fibers and lessen neuroinflammation in a mouse model of MS, data show. Emerald Health Therapeutics, the manufacturer of EHP-101, also announced plans to open Phase 2 clinical trials in patients by…

Treatment with Mayzent (siponimod) led to significant improvement in cognitive processing speed in patients with secondary progressive multiple sclerosis (SPMS), according to updated results of a Phase 3 trial. Novartis’ findings, presented at the European Academy of Neurology (EAN) congress that ran June 29–July 2 in Oslo,…

A protein leads to nerve fiber and myelin damage, particularly in progressive forms of multiple sclerosis, by activating brain immune cells called microglia, according to a new study. Its researchers also noted this protein is the target of experimental MS treatment called temelimab (GNbAC1), which showed potential in Phase 2 clinical trials. The…

Arbaclofen extended-release (ER) tablets taken twice a day can effectively reduce spasticity (muscle stiffness) in patients with multiple sclerosis (MS) with similar potency to that of standard and more-frequently-dosed baclofen (brand name Lioresal), Phase 3 clinical trials show. Latest trial data were presented in two posters during the 33rd Annual Meeting…

Users of the disease-modifying therapy Ocrevus (ocrelizumab) share a common complaint: the length of time the infusions take. It may seem petty, but an Ocrevus infusion consumes nearly an entire day. My typical infusion involves checking into the clinic, being screened by the infusion nurse for any changes, taking…

Cyxone Launches Phase 1 Trial Assessing T20K for MS This trial caught my eye because even though it’s a small, early trial, T20K is a medication derived from a plant. Animal studies have shown that the treatment can inhibit cytokines, substances that mediate inflammation. Cyxone launched the first-in-human Phase…

Cyxone launched the first-in-human Phase 1 clinical trial assessing the effects of T20K, its new therapeutic candidate for the treatment of multiple sclerosis (MS), in healthy volunteers. The announcement came after the company received approval from the Dutch Ethics Committee and Central Commission on Research Involving Human…

A clinical trial based at the Cleveland Clinic and the University of Nottingham, U.K., is recruiting patients with relapsing-remitting multiple sclerosis (RRMS) to compare two treatment strategies, the National Multiple Sclerosis Society announced. The Phase 4 study, called DELIVER-MS (NCT03535298), intends to enroll about 800…

Aubagio (teriflunomide), an approved medicine for relapsing forms of multiple sclerosis (MS), specifically targets highly metabolic and more autoreactive T-cells, analysis of the Phase 3 TERI-DYNAMIC clinical trial data shows. The findings, contrary to expectations, support a selective effect of Aubagio on different T-cell populations. The study “Teriflunomide treatment for multiple sclerosis modulates T cell mitochondrial respiration with affinity-dependent effects” was published in the Science Translational Medicine journal. In MS, immune cells, or lymphocytes known as T-cells, attack and destroy myelin, the fat-rich substance that wraps around nerve fibers (axons). Myelin loss creates lesions that affect nerves of the brain and spinal cord. Previous evidence suggested that T-cells, depending on their active or resting state, rely on specific ways of energy production or metabolism. Aubagio, marketed by Sanofi Genzyme, is a well-known inhibitor of a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), that is crucial for the activity of T-cells. However, how Aubagio selectively targets the autoreactive T-cells is poorly understood. To shed light on this matter, an international group of researchers used data from the TERI-DYNAMIC clinical trial that tested Aubagio in patients with relapsing form of MS to better understand how the therapy inhibited the patients' self-immune responses. The Phase 3, open-label TERI-DYNAMIC trial (NCT01863888) included 70 patients from Belgium, Germany, and The Netherlands, aged 18 to 56. Participants received Aubagio as a 14 milligram (mg) once-daily, oral dose, and researchers assessed the changes in immune cells' profile up to 24 weeks. Results showed that, contrary to what was expected, Aubagio was not generally decreasing T-cell levels in treated patients. Instead, it significantly reduced a particular subset of T-cells, called "Th1 helper cells." Moreover, researchers found that the diversity of T-cell receptors — the surface proteins that can recognize a particular antigen (a protein that can elicit an immune response) — making T-cells specific to a certain target was reduced in MS patients after treatment with Aubagio. These findings suggested that some T-cells were particularly susceptible to Aubagio. Using a mouse model for MS, the experimental autoimmune encephalomyelitis (EAE) model, researchers showed that the CD4+ T-cells (helper T-cells) and CD8+ T-cells, those that reacted most strongly against self-antigens, were the most sensitive to DHODH inhibition by Aubagio. Moreover, researchers saw that Aubagio was not affecting the production of pro-inflammatory molecules — called cytokines — at the cell level, but their overall decrease probably was due to the reduction in T-cell numbers. In line with these findings, CD4+ T-cells that produced the cytokine interferon gamma were significantly reduced with Aubagio treatment, whereas CD4+ T-cells that produced interleukin 17A were unchanged. This suggests that Aubagio is able to interfere with specific sub-types of immune cells. When the team compared the metabolic profile of T-cells from healthy subjects with that from patients with relapsing-remitting MS (RRMS) in both remission and in relapse phases, they found that the metabolism of T-cells from the last group was significantly altered, and thus targetable. Altogether, the results suggested that T-cells with a high-affinity to self-antigens are more susceptible to inhibition of the DHODH enzyme by Aubagio. “Therapeutic targeting of metabolic alterations might represent an attractive concept in MS, and might represent an as yet unrecognized key mechanism of teriflunomide-mediated immune modulation in this disease,” the researchers concluded.

Cyxone Nears First-in-human Trial for Investigational Preventive MS Treatment T20K Multiple sclerosis can be treated but it can’t be prevented — at least not yet. But these researchers hope that a substance derived from a natural plant protein called T20K will be able to ease or even prevent MS…

Cyxone submitted an application to the Netherlands research ethics committee to start the first clinical trial in humans testing T20K, its investigational preventive treatment for multiple sclerosis (MS). Approval by the Netherlands regulating authority…

Corrona has expanded its collaborative multiple sclerosis (MS) U.S. patient registry to include Genentech, the first pharmaceutical company to participate. Established in 2017, the Corrona MS Registry is a real-world U.S.-based registry, developed in collaboration with the National MS Society. Its goal is to help guide treatment decisions based on…

The International Pediatric Multiple Sclerosis Study Group (IPMSSG) has updated its guidelines regarding the participation of children and adolescents with multiple sclerosis (MS) in clinical trials. The new series of guidelines were published recently in Neurology, the journal of the American Academy of Neurology (AAN), in an article titled…

The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma, in collaboration with Sanofi Genzyme, for MS and other central nervous…

MC10 and AbbVie are working together to launch clinical trials exploring the use of BioStamp nPoint, a system of wearable sensors that collects health data from multiple sclerosis (MS) patients, to determine if the information may serve as meaningful measures for clinical studies. MC10’s BioStamp…

Early, positive safety results from a Phase 1 trial testing a potential immunotherapy, ATA188, in people with progressive multiple sclerosis will be detailed at the 5th Congress of the European Academy of Neurology (EAN) late next month, its developer, Atara Biotherapeutics, announced. ATA188 is an investigational and “off-the-shelf”…

Simvastatin, a widely prescribed statin that works to lower cholesterol levels, may slow brain atrophy and disease progression in people with secondary progressive multiple sclerosis (SPMS) for reasons unrelated to changes in blood cholesterol, a new analysis of a Phase 2 clinical trial reports. These findings are in…

Investigational therapy evobrutinib, also known as M2951, can reduce relapse rates and brain lesions in people with relapsing forms of multiple sclerosis (MS), 48-week data from a Phase 2 clinical trial suggest. Updated results from the trial (NCT02975349) were presented at the recent 2019 annual…

Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior to Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial. The research, “Efficacy and Safety…

Two ongoing clinical trials may help doctors better understand which type of disease-modifying therapy — those considered highly effective or those with low-to-moderate efficacy used in an escalating treatment approach — would be best for people in the early stages of  relapsing-remitting multiple sclerosis (RRMS), according to a  …

Treatment with Ocrevus (ocrelizumab) decreases the levels of neurofilament light chain (NfL) and immune B-cells in the serum and central nervous system of patients with relapsing multiple sclerosis (MS), according to results from a Phase 3 trial. The research, “Ocrelizumab treatment reduced levels of neurofilament light chain and…