Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data. Information from another trial also…
clinical trials
Ublituximab, an experimental therapy for relapsing multiple sclerosis (MS) patients, outperformed Aubagio on a number of disability-related outcomes in the ULTIMATE clinical trials, new data show. The findings were presented in a series of posters at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in…
The U.S. Food and Drug Administration (FDA) has cleared a Phase 1b/2a trial of PIPE-307, Pipeline Therapeutics‘ investigational myelin-restoring treatment, in people with relapsing-remitting multiple sclerosis (RRMS). The trial will enroll about 45 RRMS patients from multiple U.S. sites who will be randomized to receive either three months…
Eight weeks of hormone therapy was tolerable, and its use may ease the hot flashes and greater disease-related disability this life transition can cause in menopausal women with multiple sclerosis (MS), according to results of a small Phase 1b/2a trial of Duavee, an approved therapy. Public concerns over the safety of…
Higher doses of temelimab were generally safe and resulted in beneficial trends on key neurodegeneration markers in adults with relapsing forms of multiple sclerosis (MS) who already were on rituximab treatment, according to top-line data from the ProTEct-MS Phase 2 clinical trial. While the study’s small size…
NervGen Pharma has been cleared to enroll a second group of healthy volunteers into the multiple ascending dose portion of its Phase 1 clinical trial of NVG-291, a therapeutic candidate for multiple sclerosis (MS). The trial’s Safety Review Committee approved the second group after seeing promising safety data…
PIPE-307, an investigational myelin-restoring medication being developed by Pipeline Therapeutics for the treatment of multiple sclerosis (MS), appears to be safe and well tolerated in healthy adults. The results are from a Phase 1 clinical trial (NCT04725175) that evaluated the safety and tolerability of PIPE-307 in 70…
The National MS Society, together with a number of its corporate healthcare partners, want to help correct the lack of diversity in clinical trials as part of an effort toward resolving healthcare inequities in the MS community. To address these disparities, the National MS Society’s Corporate Healthcare Roundtable, a…
Administering the stem cell therapy NG-01 — designed to have neuroprotective and neuro-regenerative properties — directly into the spinal canal can significantly reduce the levels of neurofilament light chain (NfL), a neuronal damage biomarker, in people with active, progressive forms of multiple sclerosis (MS). These are the new…
Masitinib, AB Science’s experimental oral therapy, significantly slows disability progression in adults with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive MS (SPMS), according to final data from the AB07002 Phase 2b/3 clinical trial. These findings, indicating that the trial met its main goal, support…
The experimental medication ublituximab significantly reduces the number of new brain lesions with severe nerve cell degeneration in people with relapsing multiple sclerosis (MS) as compared with Aubagio (teriflunomide), according to new data from the Phase 3 ULTIMATE clinical trials. The findings showed that ublituximab induces a rapid…
Machine learning — using computer algorithms — can be used to identify people with primary progressive multiple sclerosis (PPMS) who are more likely to respond to treatment, a new study shows. The ability to predict treatment response could allow clinical trials to be designed more efficiently, researchers said. Jean-Pierre…
Synaptogenix announced plans to advance bryostatin-1, its lead candidate, into clinical trials for multiple sclerosis (MS), marking the third neurological disease the small molecule therapy is being developed to potentially treat. “Multiple sclerosis joins Alzheimer’s disease (“AD”) and Fragile X syndrome as our third indication with potential clinical…
Multiple sclerosis (MS) patients who experience reductions in spasticity after a four-week course of inpatient rehabilitation can sustain those improvements in the long term using an app-based self-training program, according to data from a clinical trial. The app also led to better adherence to the self-training program than…
VISIONARY-MS, a Phase 2 clinical trial evaluating the safety and effectiveness of CNM-Au8 in people with relapsing multiple sclerosis (MS) with disease-related visual impairment, will conclude early due to COVID-19 pandemic-related challenges. The release of trial data is expected in the second half of this year, according to…
The Swedish Medical Products Agency has approved AB Science’s request to launch in the country a confirmatory Phase 3 clinical trial of its lead candidate masitinib in adults with primary progressive multiple sclerosis (PPMS) and nonactive secondary progressive MS (SPMS). The decision comes on the heels of a similar authorization by the…
As usual, I’ve gone for what I hope to be an intriguing headline, because you’ve got to grab a reader by any means necessary. If you’ve read this far, I’m winning! This saga goes back well over a year, when my neurologist suggested I participate in a clinical trial for…
A novel algorithm that combines genetic, environmental, and clinical data could be useful for predicting whether people with a first onset of multiple sclerosis (MS)-like disease — known as clinically isolated syndrome (CIS) — will experience relapses or a worsening of their disease over time. The…
A Phase 2 clinical trial into the safety and tolerability of higher-dose temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer, GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…
A Kessler Foundation scientist has been awarded nearly $600,000 to support the development and testing of a behavioral therapy intervention aiming to improve quality of life for people with multiple sclerosis (MS). An upcoming clinical trial into the intervention (NCT05195320), expected to begin…
Acthar Gel (repository corticotropin injection) may be useful for managing disease relapses in people with relapsing-remitting multiple sclerosis (RRMS) who fail to respond to treatment with corticosteroids, according to results from a small clinical trial. The study, “Results from a multicenter, randomized, double-blind, placebo-controlled study…
The ENSURE-2 Phase 3 clinical trial, evaluating Immunic Therapeutics’ experimental oral therapy IMU-838 (vidofludimus calcium) in adults with relapsing-remitting multiple sclerosis (RRMS), has enrolled its first patient. The milestone, announced in an email to Multiple Sclerosis News Today, follows the recruitment of the first RRMS patient in…
Emerald Health Pharmaceuticals will soon begin enrollment in a Phase 2a clinical trial investigating its cannabidiol-derived therapy EHP-101 in relapsing forms of multiple sclerosis (MS). The trial (NCT04909502) aims to recruit 50 patients, ages 18-55, with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
Atara Biotherapeutics has partnered with Imeka to use its proprietary biomarker imaging technology in the ongoing EMBOLD Phase 2 clinical trial, which is investigating ATA188 for the treatment of progressive forms of multiple sclerosis (MS). The imaging technology will be used to determine if Atara’s ATA188…
A Phase 1 clinical trial investigating the safety and tolerability of Anokion‘s ANK-700 in people with relapsing-remitting multiple sclerosis (RRMS) has begun enrolling patients for its multiple ascending dose part. This opening of the study’s second part follows positive safety signs in patients given the one of two doses of…
The French Health Authority has approved AB Science’s request to launch a Phase 3 clinical trial to confirm the safety and effectiveness of its lead candidate masitinib in adults with primary progressive multiple sclerosis (PPMS) and nonactive secondary progressive MS (SPMS). “We are very excited to initiate…
Other autoimmune conditions, particularly those characterized by the presence of anti-TPO antibodies, should not preclude patients with multiple sclerosis (MS) from receiving treatment with Lemtrada (alemtuzumab), according to an analysis of pooled data from clinical trials and post-market data. The study, “Autoimmunity and long-term safety and efficacy…
Adults with multiple sclerosis (MS) and depression or anxiety, especially those of minority groups, are being asked to join a clinical trial assessing the benefits of eSupport Health’s online support group program, the National MS Society announced in a press release. The CONNECT study is particularly focused on Black and…
NervGen Pharma has received approval to begin testing multiple ascending doses of NVG-291, its lead therapeutic candidate for multiple sclerosis (MS) and other neurologic conditions, in a Phase 1 trial with healthy volunteers. This multiple ascending dose (MAD) part, in which participants will receive increasing doses of NVG-291…
MS-STAT2, a clinical trial testing whether the cholesterol-lowering medication simvastatin might slow disability progression in secondary progressive multiple sclerosis (SPMS), has finished enrollment. A total of 964 people are now in the trial (NCT03387670), making it the largest progressive MS trial not run by a commercial…