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…
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…
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…
December 3, 2021 News by Steve Bryson, PhD Aubagio Reduces Lesions in Children in Trial, but Relapse Data Troubled Aubagio (teriflunomide) failed to significantly reduce relapses in children with multiple sclerosis (MS), but two years of treatment decreased the number of brain lesions on MRI scans, according to the final results of the Phase 3 TERIKIDS clinical trial. Importantly, the lack of a signficantly lower relapse rate…
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…
June 15, 2021 News by Marisa Wexler, MS FDA Rejects Expansion of Aubagio for Pediatric MS The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…
May 5, 2021 News by Steve Bryson, PhD Relapsing MS Patients May Fare Better on Zeposia Than Aubagio Treatment with Zeposia (ozanimod) significantly reduces the risk of relapse, decreases the proportion of patients experiencing a relapse, and has a better safety profile than Aubagio (teriflunomide) for people with relapsing multiple sclerosis (MS), according to an indirect comparison of clinical trial data.
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…
December 7, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Quality of Life, Virtual Reality Rehab, Aubagio and Brain Atrophy, Cancer Risk Review Study Examines Factors That Affect MS Patientsā Quality of Life What affects the qualify of your life as someone who lives with MS? Fatigue is at the top of my list, followed by difficulty walking. Now, COVID-19 plus gray, winter weather have added a bit of depression. So,…
September 10, 2020 News by Marta Figueiredo, PhD #MSVirtual2020 – Ponesimod Superior to Aubagio in Delaying Disability Progression in Relapsing MS, Trial Data Show Janssen Pharmaceuticalsā investigational oral therapy ponesimod is superior to Sanofiās Aubagio (teriflunomide) in delaying disability progression in adults with relapsing multiple sclerosis (MS), according to exploratory analyses of OPTIMUM clinical trial data. These and other findings from Janssenās MS research program, including on the health…
August 19, 2020 News by Joana Carvalho, PhD Sanofi to Acquire Principia Biopharma in $3.6 Billion Transaction In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS). The decision was unanimously approved by the board of directors of…
June 25, 2020 News by Joana Carvalho, PhD 1st Relapsing MS Patient Enrolls in Phase 3 Trial of Oral SAR442168 A first person has enrolled inĀ Sanofiās Phase 3 trial evaluatingĀ SAR442168, an oral BTK inhibitorĀ intended to treat relapsing forms of multiple sclerosis (MS), Sanofiās partner, Principia Biopharma, announced. āWe are delighted that Sanofi has initiated ā¦ [this] trial in patients with relapsing MS,ā Roy Hardiman, chief…
June 16, 2020 News by Patricia Inacio, PhD Aubagio Safely Used by 5 MS Patients With Active COVID-19 Infection Five people with multiple sclerosis (MS) who tested positive for COVID-19Ā whileĀ being treated with Aubagio (teriflunomide)Ā Ā all developed a mild infection, had good outcomes, and experienced no disease relapses, a case study reported. These findings suggest that use of Aubagio, a disease-modifying therapy that acts on the immune system,…
May 4, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Diagnosis by Antibody, Ocrevus After 6 Years, Telemedicine, New DMT Pill New Nanosensor May Help to Diagnose MS at Early Stages My neurologist likes to say that “brain is time.” The sooner MS is treated the more time you can buy before the brain begins to deteriorate and MS symptoms appear. Being able to diagnose MS sooner means earlier treatment.
April 24, 2020 News by Marisa Wexler, MS Sanofi’s BTK Inhibitor Seen to Effectively Reduce Brain Lesions in Phase 2 Trial The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…
April 20, 2020 News by Marisa Wexler, MS Sanofi to Detail Trial Results of Oral Relapsing MS Therapy Online on Thursday Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…
November 6, 2019 News by Alice MelĆ£o, MSc European 3TR Project Unites Experts in Effort to Make Treatment More Personal and Effective A new public-private initiative brings academic and industry researchers from 15Ā European countries together in a large-scale effort to understand differences and commonalities in seven immune-mediated and inflammatory diseases, including multiple sclerosis, so to better predict a patient’s likely response to treatment and likely disease progression. The project, called 3TR…
September 23, 2019 News by Jose Marques Lopes, PhD Partnership Aims for FDA-approved App That Aids Mental Health in MS, Sanofi Announces SanofiĀ is working with Happify HealthĀ to develop an app that addresses the mental health of people with multiple sclerosis (MS) through cognitive behavior therapy. The physical symptoms of MS, such as fatigue and spasticity, are well-documented. But many patients also struggle with bouts of depression,…
May 24, 2019 News by Vijaya Iyer, PhD First Patient Dosed in Phase 2B Trial Testing SAR442168 Therapeutic Candidate for RRMS 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,Ā in collaboration withĀ Sanofi Genzyme, for MS and other central nervous…
May 13, 2019 News by Patricia Inacio, PhD #AANAM – Aubagio at Higher Dose Shows Long-term Efficacy in Variety of Patients, Trial Data Show AubagioĀ taken as 14 milligram (mg) tablet once daily significantly reduces the risk of relapse in people with relapsing multiple sclerosis (MS) over time irrespective of their prior treatment history, a pooled analysis of Phase 2 and Phase 3 trial results show. The findings were presented at the 2019…
November 20, 2018 News by Alice MelĆ£o, MSc FDA Approves Generic Version of Aubagio to Treat Relapsing MS, Glenmark Pharma Says The U.S. Food and Drug Administration (FDA) has approved a generic version of Ā Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer,Ā Glenmark Pharmaceuticals. The FDAās decision to approve the company’s application for teriflunomide tablets at two…
November 6, 2018 News by Jose Marques Lopes, PhD Denali and Sanofi Partner to Develop Potential Treatments for MS, Other Neurological Disorders Denali Therapeutics andĀ SanofiĀ will collaborateĀ to develop a compound called DNL747 that may treatĀ multiple sclerosis (MS) and other neurodegenerative disorders. The companies will also jointly work on the development of a separate possible therapy, DNL758, for systemic inflammatory diseases such as rheumatoid arthritis and psoriasis. Both DNL747 and DNL758…
October 5, 2018 Columns by Ed Tobias Could Government Probe Threaten Pharma Patient Assistance Programs? Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…
August 10, 2018 News by Jose Marques Lopes, PhD Hair Loss Seen in RRMS Patients Using Aubagio Often Temporary and Mild, Study Says Hair thinning in relapsing-remitting multiple sclerosis (RRMS) patients usingĀ AubagioĀ is usually mild and temporary, and does not require stopping treatment, a small real-world study reports. The research, āReal-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical…
August 2, 2018 News by Alice MelĆ£o, MSc Potential B-cell Targeting Oral MS Treatment, PRN2246, Shows Ability to Reach Brain in Phase 1 Study Results from a first-in-human study assessing the safety and early activity of PRN2246Ā confirmed that the oral compound can reach into the brain and spinal cord. This finding adds new evidence that PRN2246 has the potential to target the immune cells that drive the inflammatory process involved in multiple sclerosis…
July 13, 2018 Columns by John Connor Steering My Own Boat and Making a Splash The U.K.’s National Health Service (NHS) turned 70 last week. In England, yes, we are mourning our semi-final defeat by Croatia in the World Cup, but to most of us, the NHS is the U.K.’s crowning glory. There are innumerable problems and proposed solutions involving the institution, yet…
May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
October 30, 2017 News by Patricia Silva, PhD #MSParis2017 ā Aubagio Can Help Slow Progression to an MS Diagnosis, Researcher Says Aubagio (teriflunomide)Ā can help to delay first clinical signs of multiple sclerosis (MS) from progressing to a definite diagnosis in a person, and treatment should likely begin as soon as that first episode is confirmed,Ā Robert Zivadinov, a professor of neurology and director of the Buffalo Neuroimaging Analysis Center, said…
October 27, 2017 News by BioNews Staff #MSParis2017 ā Lemtrada Shows Good Safety and Lasting Efficacy Over 7 Years, Doctor Says in Interview Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview atĀ the…