Following negative Phase 3 trial results, Sanofi announced that it will not be pursuing approval of its experimental therapy tolebrutinib for primary progressive multiple sclerosis (PPMS). Meanwhile, a decision from the U.S. Food and Drug Administration (FDA) on tolebrutinib’s use in nonrelapsing secondary progressive MS (SPMS) is likely…
Trial results
Increasing the dose of Ocrevus (ocrelizumab) by two- or threefold, depending on a person’s weight, did not provide additional benefit in slowing disability progression compared with the standard regimen in people with primary progressive multiple sclerosis (PPMS). That’s according to top-line data from the Phase 3b GAVOTTE…
Enrollment is complete for a Phase 2 trial testing Zenas Biopharma’s obexelimab in people with relapsing forms of multiple sclerosis (MS). The trial, MoonStone (NCT06564311), is investigating how safe obexelimab is when given as weekly under-the-skin (subcutaneous) injections, and how well it works in approximately 93 participants…
Autologous hematopoietic stem cell transplant (aHSCT) could slow disease progression in people with relapsing-remitting multiple sclerosis (RRMS), according to a study tracking MS patients in Sweden. The procedure was associated with sustained reductions in biomarkers linked to progressive MS. The results also showed that a significant portion of patients…
More than 90% of relapsing-remitting multiple sclerosis (RRMS) patients who received Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium have not experienced confirmed disability worsening after nearly three years. That’s according to new data from the EMPhASIS Phase 2 clinical trial (NCT03846219) and its open-label extension (OLE)…
Three months of daily supplements containing ellagic acid — an antioxidant found naturally in many fruits and plants — significantly reduced disability levels and eased fatigue, depression, and anxiety in people with multiple sclerosis (MS), according to a small clinical study from Iran. Indeed, the researchers noted a “statistically…
Foralumab was well tolerated in people with nonactive secondary progressive multiple sclerosis (SPMS), according to data from a small, open-label study conducted under an expanded access program. The therapy, being developed by Tiziana Life Sciences, also eased fatigue and lessened disability in some participants. The promising findings formed…
A high dose cholecalciferol, a form of vitamin D, significantly reduced the risk of further disease activity in people with clinically isolated syndrome (CIS), published findings from a Phase 3 trial show. Vitamin D was similarly effective for reducing disease activity among a subgroup of participants who would…
A large majority of people with relapsing-remitting multiple sclerosis (RRMS) who received Tysabri (natalizumab) in a real-world setting experienced no evidence of disease activity for as long as six years, according to a study from a single center in Hungary. No evidence of disease activity, known as NEDA-3,…
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…
By studying pairs of identical twins, researchers have identified a population of immune cells whose early activation and migration into the brain might contribute to multiple sclerosis (MS) onset. MS patients showed an altered profile of a population of immune cells called CD8 T-cells in the blood relative to…
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…
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,…
People with relapsing forms of multiple sclerosis (MS) being treated with an infusion CD20 inhibitor such as Ocrevus (ocrelizumab) can safely transition to the more recent Briumvi (ublituximab-xiiy), which is given in shorter infusion times. That’s according to data from the ENHANCE Phase 3b clinical trial…
The experimental BTK inhibitor evobrutinib was no better than Aubagio (teriflunomide) at preventing relapses, reducing brain lesions, or slowing disability progression in people with relapsing forms of multiple sclerosis (MS), according to data from two Phase 3 trials. Both medications had generally similar safety profiles, although increases…
In people with multiple sclerosis (MS) who have previously received a stem cell transplant, a second transplant can be performed safely and may help stabilize disability. That’s according to the study “Second Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis: A Single-Center Prospective Experience,” which…
Six of eight patients with nonactive secondary progressive multiple sclerosis (SPMS) being treated with foralumab nasal spray — all part of an intermediate-size expanded access program (EAP) allowing the therapy’s use — have experienced reductions in their fatigue levels. That’s according to treatment developer Tiziana Life Sciences,…
Ocrevus (ocrelizumab) did not significantly reduce the number or volume of inflammatory lesions in the meninges in people with multiple sclerosis (MS), according to a recent pilot study. While inflammation in the meninges, the protective membranes that surround the brain and spinal cord, is thought to be driven…
A six-month telehealth program designed to help participants change their dietary and lifestyle habits resulted in an increased level of physical activity and clinically relevant weight loss for most obese people with multiple sclerosis (MS) who took part, a clinical trial found. In fact, about 2 in 3 of…
A 20-week talk therapy program led to significant reductions in fatigue for people with multiple sclerosis (MS) — benefits that were sustained to the end of the year-long trial regardless of whether patients participated in additional booster sessions. Such sessions were offered two and four months after the end…
Adhering to an aerobic exercise program of moderate to intense cycling for 12 weeks significantly eased pain and fatigue in people with multiple sclerosis (MS), allowing them to be more active in daily life, a small pilot clinical trial found. Results were similar for patients in the trial’s forced…
Adhering to a low-fat diet for three months was found to significantly ease fatigue among people with multiple sclerosis (MS), according to data from a pilot clinical trial. The diet, which restricted total fat intake to less than 20% of calories per day, had a good adherence. Unlike other…
ATA188, an experimental cell therapy targeting the Epstein-Barr virus, failed to outperform a placebo at easing disability levels in people with nonactive progressive forms of multiple sclerosis (MS), according to data from the Phase 2 portion of the EMBOLD clinical trial. The medication also showed no signs of…
More than three-quarters of people with relapsing forms of multiple sclerosis (MS) who received Zeposia (ozanimod) in the RADIANCE clinical trial and its extension study still haven’t experienced confirmed disability progression after eight years of follow-up, new data shows. Among those who progressed, about half of disability progression…
Tysabri (natalizumab) significantly reduced the development of brain lesions on MRI scans in Japanese people with relapsing-remitting multiple sclerosis (RRMS), according to a new study. The therapy also eased or stabilized disability levels in most patients after five years of treatment, and significantly reduced the annual rate of…
Atara Biotherapeutics now is planning to announce in November the one-year data from its EMBOLD Phase 1/2 study, which is testing the company’s experimental treatment ATA188 for progressive forms of multiple sclerosis (MS). The results, originally expected in October, will cover the trial’s primary endpoint of…
More daily physical activity, better physical condition, and lower disability were all associated with less fatigue for people with relapsing-remitting multiple sclerosis (RRMS), according to a clinical trial in Finland. “The findings are interesting and support previous studies very well,” Marko Luostarinen, a doctoral researcher at the University of…
Nearly 80% of adults with highly active relapsing-remitting multiple sclerosis (RRMS) were free of relapses or confirmed disability worsening two years after receiving stem cell transplant, according to a real-world study in Denmark. Moreover, more than two-thirds (69%) of these RRMS patients achieved a clinical outcome called NEDA-3, or…
A microRNA called miR-548a-3p, a small molecule important for regulation of gene activity, may help to identify people with multiple sclerosis (MS) who will reach no evidence of disease activity — a status known as NEDA-3 — after treatment with Gilenya (fingolimod), a study found. Data showed that…
People with relapsing multiple sclerosis (MS) who experienced disease activity while on oral therapies had less disease activity after switching to Kesimpta (ofatumumab), according to an analysis of data from the Phase 3 ARTIOS clinical trial. The patients previously were on Gilenya (fingolimod), or fumarate-based therapies such…