March 6, 2024 News by Margarida Maia, PhD ACTRIMS 2024: Tolebrutinib fails to eliminate iron rim lesions in Phase 2 trial Nearly one year of treatment with tolebrutinib, an oral small molecule being developed by Sanofi, failed to eliminate iron rim lesions in adults with multiple sclerosis (MS), according to data from a small Phase 2 clinical trial. Researchers are continuing to examine study results to determine…
October 16, 2023 News by Lindsey Shapiro, PhD ECTRIMS 2023: Tolebrutinib found to show benefits for up to 3 years Treatment with tolebrutinib for up to nearly three years was tied to low relapse rates, stable disability, and few new brain lesions among people with relapsing forms of multiple sclerosis (MS), according to new data from the long-term safety (LTS) extension of a Phase 2b trial. The data…
April 26, 2023 News by Lindsey Shapiro, PhD AAN 2023: Tolebrutinib safely lowers relapse rates over 2.5 years About 2.5 years of treatment with tolebrutinib was associated with low relapse rates and stable disability levels among people with relapsing forms of multiple sclerosis (MS), according to data in an ongoing, open-label extension of a Phase 2b trial. The oral treatment also continued to show a “favorable”…
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…
May 2, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: PoNS, MS Survey, Nerve Damage Biomarker, Tolebrutinib PoNS Device for MS-associated Gait Problems Now Available in US One clinical trial showed that MS patients who used the portable neuromodulation stimulator (PoNS) device as part of an exercise program had greater improvements in gait than those using only the exercise program. A second trial showed that those…
April 28, 2022 News by Marisa Wexler, MS #AAN2022 ā Tolebrutinib Reduces Brain Damage Up to 1.5 Years in Trial Long-term treatment with tolebrutinib significantly reduced signs of disease-related brain damage in people with relapsing multiple sclerosis (MS), according to new data from a Phase 2 clinical trial and its extension study. Specifically, the investigational oral therapy was found to keep the number of inflamed brain lesions…
April 22, 2022 News by Lindsey Shapiro, PhD Chinese Authorities Approve Trial of SN1011; US Study on Horizon The National Medical Products Administration (NMPA) of China has agreed to approve a Phase 2 trial testing the safety and efficacy of the investigational therapy SN1011 in people with multiple sclerosis (MS). SN1011 is being developed by SinoMab Bioscience to treat a range of autoimmune and inflammatory…
March 7, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: ‘Cog Fog,’ Tolebrutinib, Ublituximab, Spinal Atrophy #ACTRIMS2022 ā Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…
March 3, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Tolebrutinib More Potent Than Other BTK Blockers Tolebrutinib, an investigative inhibitor of Brutonās tyrosine kinase (BTK) being developed byĀ SanofiĀ to treat all forms ofĀ multiple sclerosis (MS), shows the potential to be more potent than other BTK inhibitors also in advanced clinical trials, scientists reported. The findings, based on preclinical data, were shared at the Americas…
November 15, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: NVG-291, Ocrevus, Tolebrutinib, Tecfidera Nerve Repair Therapy NVG-291 Safe, Well-tolerated in Healthy People This experimental therapy has a long way to go before it becomes reality. But it’s encouraging that this first step found NVG-291’s side effects to be mild and short-lasting. NVG-291 is designed to promote remyelination by modulating an enzyme called…
November 12, 2021 News by Patricia Inacio, PhD Phase 3 Trials of Tolebrutinib in MS Forms to Include Digital Measures Sanofi GenzymeĀ has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS). Through this joint effort, Koneksaās digital biomarkers were applied to clinical trials of Parkinsonās…
November 9, 2021 News by Marisa Wexler, MS Ocrevus Still Top Therapy for Progressive MS Forms, Report Finds Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…
July 30, 2021 Columns by Ed Tobias Could BTK Inhibitors Be the Next Big MS Treatment? Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is. Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells…
March 30, 2021 News by Forest Ray PhD Sanofi Genzyme Launches Recruitment Website for Tolebrutinib Trials Sanofi Genzyme has launched a website to help connect people with multiple sclerosis (MS) to one of the company’s four ongoing clinical trials testing its investigational therapy tolebrutinib. Interested men and women may qualify for a clinical trial if they are…
December 21, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Stem Cell Study, Protein Predictor, Tolebrutinib and STEP Trials Stem Cell Therapy Shows 2-year Benefit for Progressive MS Patients in Phase 1 Trial Stem cell studies always catch my eye. This very small study involves people treated with their own bone marrow, which was collected and expanded to give it the ability to modulate the MS immune response…
December 17, 2020 News by Joana Carvalho, PhD Progressive MS Patients Urged to Enroll in Phase 3 Trials of Tolebrutinib Investigators are looking for people with progressive forms of multiple sclerosis (MS) to participate in two Phase 3 clinical trials assessing the safety and effectiveness of tolebrutinib (SAR442168), an oral BTK inhibitor that is being investigated as a potential treatment, the National Multiple Sclerosis SocietyĀ announced…
December 14, 2020 News by Diana Campelo Delgado Sanofi Enrolling for 2 GEMINI Trials Testing Tolebrutinib vs. Aubagio for Relapsing MS Two global Phase 3 clinical trials, both comparing Sanofi Genzymeās investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies ā dubbed GEMINI 1 and GEMINI 2 ā will…
September 11, 2020 News by Joana Carvalho, PhD #MSVirtual2020 – Tolebrutinib Prevents Myelin Loss in Mouse Model of MS-like Demyelination Tolebrutinib (SAR442168), an investigational oral BTK inhibitorĀ to treat relapsing forms of multiple sclerosis (MS), was seen to prevent the loss of myelinĀ when given to a mouse model of demyelination in a preclinical study. The investigative therapy achieves this by preventing…