After months of delay, the U.S. Food and Drug Administration (FDA) has rejected Sanofi‘s application seeking approval of tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (MS). While Sanofi announced earlier this month that the decision was likely to be delayed again…
Trial results
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…
A Phase 2 clinical trial testing PIPE-307, an experimental therapy designed to support myelin repair in people with multiple sclerosis (MS), has failed to meet its primary or secondary efficacy goals. The U.S.-based VISTA trial (NCT06083753) enrolled more than 180 adults with relapsing-remitting MS (RRMS). Participants received…
Genentech‘s experimental oral therapy fenebrutinib has become the first Bruton’s tyrosine kinase (BTK) inhibitor to show positive Phase 3 results in both relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS), the company announced. In what Genentech called “unprecedented results,” two late-stage trials testing…
Obexelimab, a therapy Zenas Biopharma is developing for a range of autoimmune diseases, almost completely prevented the formation of new inflammatory lesions in adults with relapsing forms of multiple sclerosis (MS) in the first three months of a clinical trial. That’s according to data from the first part…
Up to six years of continuous treatment with Briumvi (ublituximab) led to sustained reductions in relapse rates and a low rate of disability progression in people with relapsing forms of multiple sclerosis (MS), with no new safety concerns reported. That’s according to new long-term data from the…
Children and adolescents living with multiple sclerosis (MS) seem to benefit at least as much — and for some outcomes, significantly more — from Ocrevus (ocrelizumab) as from treatment with Gilenya (fingolimod), now the only MS therapy approved for pediatric patients in the U.S. That’s according to…
A stem cell transplant may offer better long-term results for people with aggressive multiple sclerosis (MS) compared with standard high-efficacy drug treatment, according to new evidence presented at a major European conference this week. Specifically, researchers found that an autologous hematopoietic stem cell transplant (aHSCT) was superior to…
Targeting a protein called SOX6 could be an effective way to promote myelin repair in people with multiple sclerosis (MS), a study found. Researchers said the results point to a way for new therapies to treat the condition. The study found SOX6 could control the maturation of oligodendrocytes, the…
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…
Fumarate-based therapies like Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate) are equally effective among Black, Hispanic, Asian, and white adults with relapsing forms of multiple sclerosis (MS) in the U.S., the largest real-world study of its kind shows. “The findings of this study suggest that fumarate medicines…
Fenebrutinib significantly reduced the occurrence of new brain lesions with active inflammation in people with relapsing multiple sclerosis (MS), a Phase 2 clinical trial found. In the open-label extension portion of the FENopta trial (NCT05119569), disease activity “remained very low” for nearly one year, researchers wrote, with 98%…
A global clinical trial has been launched to evaluate the oral therapy candidate BMS-986368 for treating spasticity — muscle stiffness and spasms — in people with multiple sclerosis (MS). The Phase 2 study (NCT06782490), called BALANCE-MSS-1, will enroll about 200 adults with MS who have experienced spasticity…
Mesenchymal stem cell (MSC) therapy is safe and well tolerated, and leads to improvements in disability and a reduction in lesion burden in people with multiple sclerosis (MS), according to a review of published studies. MSC treatments also reduced levels of biomarkers associated with nerve damage and inflammation,…
Vibration therapy, which provides mechanical stimulation to activate muscles and sensory receptors, may offer a promising new approach for easing fatigue in people with multiple sclerosis (MS), according to new data from a clinical trial. Patients who received vibration therapy reported reduced perceived fatigue and also showed significant gains…
Nearly two-thirds of people with multiple sclerosis (MS) who underwent a stem cell transplant showed no signs of confirmed disability progression five years later, according to a study tracking MS patients in the U.K. The results were generally better for people with relapsing-remitting MS (RRMS), but nearly half…
A team of U.S. and Chinese researchers appears to have unlocked a novel way to stop T-cells from attacking the body in multiple sclerosis (MS) and other autoimmune diseases, according to the findings of a new study. An experimental therapy called BiTS, developed based on these new molecular insights,…
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)…
Body mass index (BMI), a measure commonly used measure of body fat based on a person’s height and weight, does not seem to affect responses to stem cell transplant in people with multiple sclerosis (MS), a study found. While the efficacy of an autologous transplant — one that…
Clemastine fumarate, an antihistamine, boosted disease progression by more than five times in adults with progressive multiple sclerosis (MS), according to data from a Phase 1/2 trial. “Likely nobody in the MS field, us included, knew about this potential [clemastine] toxicity until we collected the data presented here,” the…
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…
Injections of methotrexate into the spinal canal given every three months were safe and well tolerated, and helped adults with progressive forms of multiple sclerosis (MS) maintain stable disease levels for up to nine years. That’s according to data from a small, open-label Phase 1 clinical study (NCT02644044)…
While a four-month progressive resistance training program improved muscle strength in people with secondary progressive multiple sclerosis (SPMS) in the Netherlands, it did not significantly change their risk of developing cardiovascular disease, a small study showed. Individual cardiovascular risk factors and 10-year risk estimation tools showed no significant changes…
Rituximab, sometimes used off-label as a multiple sclerosis (MS) treatment, may be as effective — at a much lower cost to patients — as the approved therapy Ocrevus (ocrelizumab) at managing relapsing forms of the disease, a new study from Egypt suggests. The study’s results showed that the…
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…
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…
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…
Treatment with Tysabri (natalizumab) may help delay disability progression in people with secondary progressive multiple sclerosis (SPMS) over Rebif (interferon beta-1a), an analysis of data from two clinical trials suggests. While the trials initially failed to demonstrate slowing disease progression, a significant benefit was observed when accounting…
Myrobalan Therapeutics has been awarded a grant of more than $850,000 from the National Multiple Sclerosis Society to advance its new oral candidate MRO-002 for treating progressive forms of multiple sclerosis (MS). The funding was made through the society’s Fast Forward program, which seeks to bridge the…