March 5, 2024 News by Marisa Wexler, MS ACTRIMS 2024: Evobrutinib fails to show superiority to Aubagio in Phase 3 trials 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…
February 19, 2024 News by Lindsey Shapiro, PhD Sanofi launches Phase 3 frexalimab trials after positive Phase 2 data Bolstered by Phase 2 trial data showing that frexalimab safely reduces the number of brain lesions in people with relapsing forms of multiple sclerosis (MS), developer Sanofi has launched a pair of Phase 3 studies that will test the investigational therapy in relapsing and progressive MS. One of…
December 11, 2023 News by Andrea Lobo, PhD FDA puts partial hold on Phase 3 clinical trials of fenebrutinib in MS The U.S. Food and Drug Administration (FDA) has placed a partial hold on Genentechās ongoing Phase 3 clinical trials testing fenebrutinib for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS). The decision was based on two cases of patients who experienced elevations in their…
December 7, 2023 News by Marisa Wexler, MS Phase 3 studies of BTK inhibitor evobrutinib fail to meet main goal The Phase 3 EVOLUTION clinical trials have failed to demonstrate that evobrutinib is more effective than the approved medication Aubagio (teriflunomide) at preventing disease flares in people with relapsing types of multiple sclerosis (MS). The findings, which were shared by the drug’s developer Merck KGaA (known…
October 12, 2023 News by Marisa Wexler, MS ECTRIMS 2023: Under-the-skin Ocrevus found to be powerful in MS A new under-the-skin formulation of Ocrevus (ocrelizumab) ā administered in 10 minutes ā is at least as effective as the approved intravenous, or into-the-vein, formulation among people with multiple sclerosis (MS), according to new clinical trial data. Most people given either the new subcutaneous formulation or the intravenous…
August 24, 2023 News by Marisa Wexler, MS Aubagio reduces MS risk in people with disease-like signs: Phase 3 trial Aubagio (teriflunomide) can significantly reduce the risk of developing multiple sclerosis (MS) among adults with signs of MS-like brain damage who don’t yet have any disease symptoms, according to findings from a clinical trial. The results were presented earlier this year at the American Academy of Neurology…
July 14, 2023 News by Marisa Wexler, MS Positive results found for new under-the-skin Ocrevus formulation A new formulation of Ocrevus (ocrelizumab), given as a 10-minute under-the-skin injection, was comparable to the approved intravenous version of the therapy in people with multiple sclerosis (MS), according to top-line results from a Phase 3 clinical trial. The medication’s developer, Roche, is planning to submit data from…
April 18, 2023 News by Margarida Maia, PhD Vitamin D at high dose doesn’t lower MS relapse risk, Phase 3 trial finds A high-dose vitamin D supplement did not reduce the risk of relapses in people with relapsing-remitting multiple sclerosis (RRMS) already using a disease-modifying therapy to control disease activity, according to findings of a Phase 3 clinical trial. The VIDAMS study (NCT01490502) ā standing for Vitamin D…
February 3, 2023 News by Marisa Wexler, MS Biosimilar Comparable in Safety, Efficacy to Tysabri in Phase 3 Trial PB006, a biosimilar to Biogenās approved treatment Tysabri (natalizumab), showed similar safety and efficacy as the original medication in peopleĀ with relapsing-remitting MS (RRMS), according to data from a Phase 3 clinical trial. “The Antelope trial reported equivalence between [PB006 and Tysabri] treatment across efficacy, safety, and secondary…
January 3, 2023 News by Lindsey Shapiro, PhD FDA OKs Phase 3 Trial of Masitinib for Progressive Forms of MS The U.S. Food and Drug Administration (FDA) has cleared AB Science to initiate a Phase 3 clinical trial of its investigational treatment masitinibĀ in people with progressive forms of multiple sclerosis (MS). The decision follows approvals in several European countries that will also host trial sites, including…
July 1, 2022 News by Lindsey Shapiro, PhD Phase 3 Tolebrutinib Trials Pause US Enrollment Over Safety Concerns The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials testing the investigational therapy tolebrutinib in people with multiple sclerosis (MS) and myasthenia gravis based on reports of medication-induced liver injury. Under the clinical hold, new enrollment at U.S. sites…
June 14, 2022 News by Margarida Maia, PhD Dysport Wins Positive Opinion in Europe for Treating Bladder Issues Dysport (abobotulinumtoxinA), a form of purified botulinum toxin, has received a positive opinion in Europe for managing urinary incontinence in adults with neurogenic detrusor overactivity (NDO), or overactive bladder. The opinion is specifically for those who experience bladder issues due to multiple sclerosis (MS) or spinal cord…
June 17, 2020 News by Joana Carvalho, PhD Phase 3 Trial of GA Depot for Relapsing MS Advances With $20M Support Mapi Pharma, supported by an additionalĀ $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221),Ā which opened in October 2019,…
September 13, 2019 Columns by Ed Tobias Stem Cell Program That Treated Selma Blair Closes Its Doors Richard Burt, MD, the chief of Northwestern Medicine’s immunotherapy for autoimmune diseases division, is taking a sabbatical, and the stem cell program he has headed for many years, which treated a number of people with MS, is shutting down. Burt headed a Phase 3 clinical trial…
April 12, 2016 News by Patricia Silva, PhD MedDay Raises $38.5M to Finance Phase 3 Trial Targeting Progressive MS MedDay SASĀ recently announced that it has raised ā¬34 million, about $38.5 million, in a Series B financing round. The moneyĀ will enable the company to lead a confirmatory Phase 3 clinical trial, called SPI2, in the United StatesĀ toĀ assess itsĀ lead candidate, MD1003, as a treatment for progressive multiple sclerosis (MS). MedDayĀ concluded…