The U.S. Food and Drug Administration (FDA) has placed a partial hold on Genentech’s 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…
clinical trials
Treatment with Mavenclad (cladribine) over two years significantly improved physical and mental health aspects of quality of life in people with highly active relapsing multiple sclerosis (MS), according to a final analysis of data from the Phase 4 CLARIFY-MS study. Mavenclad is an oral medication approved for people with…
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…
A new clinical trial in Australia, called PLATYPUS, will simultaneously test two medications that have already been approved for other conditions in people with progressive forms of multiple sclerosis (MS). The study, expected to launch in January, will use an adaptive design, meaning data will be analyzed as…
Tiziana Life Sciences has dosed four new participants in an expanded access program investigating its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS), the company announced. A total of 10 SPMS patients are now being followed outside of clinical trials in foralumab’s expanded…
A novel therapy in which neural stem cells are injected into the brain was well tolerated by 15 people with secondary progressive multiple sclerosis (SPMS) in a pilot clinical trial. Participants’ disability levels and cognition, as well as markers of inflammation and nerve damage, all remained stable for up…
Extending Tysabri (natalizumab) dosing intervals based on the drug’s blood levels was as effective at controlling disease activity in people with relapsing-remitting multiple sclerosis (RRMS) as the approved four-week dosing regimen. That’s according to results from NEXT-MS (NCT04225312), a Phase 4 clinical trial studying whether tailoring Tysabri’s…
The Patent and Trademark Office intends to grant a U.S. patent covering all dosing regimens of vidofludimus calcium — being developed as IMU-838 — for the treatment of multiple sclerosis (MS). That includes the doses being used in developer Immunic Therapeutics’ ongoing clinical program, according to a…
Nearly two years of treatment with Vumerity (diroximel fumarate) significantly reduced relapse rates by more than 80% in people with relapsing-remitting multiple sclerosis (RRMS), according to the final published details of the EVOLVE-MS-1 clinical trial. MRI scans also showed the number of active inflammatory lesions and new…
InSilicoTrials (IST) has received this year’s Innovation Radar Prize for its efforts to harness artificial intelligence (AI) to advance clinical trials and predictive technologies that may benefit people with multiple sclerosis (MS) and other diseases. Launched in 2015 by the European Commission, the award recognizes European Union (EU)-funded…
A commercial probiotic supplement containing the yeast Saccharomyces boulardii significantly eased pain and fatigue, and improved mental health and quality of life, in people with relapsing-remitting multiple sclerosis (RRMS), according to data from a clinical trial in Iran. The probiotic, BioDigest, also reduced inflammation and oxidative stress, a form…
ChariotMS, the world’s first clinical trial to test whether Mavenclad (cladribine) can slow the worsening of upper limb function in people with progressive multiple sclerosis (MS), has now enrolled 100 participants. The announcement means the Phase 2 trial (NCT04695080) has reached 50% of its target recruitment goal.
ATA188, an experimental cell therapy targeting the Epstein-Barr virus, failed to outperform a placebo at easing disability levels in people with nonactive progressive forms of multiple sclerosis (MS), according to data from the Phase 2 portion of the EMBOLD clinical trial. The medication also showed no signs of…
The Swank and Wahls diets — two dietary strategies often adopted by people with multiple sclerosis (MS) — were similarly effective at easing functional disability after six months among people with relapsing-remitting MS (RRMS), according to data from a small clinical trial. These functional gains were mostly driven…
A Phase 1 clinical trial evaluating LPX-TI641, Lapix Therapeutics‘ experimental therapy for multiple sclerosis (MS) and other autoimmune diseases, has dosed its first participants. The first-in-human trial (NCT05853835) of healthy adult volunteers follows the recent clearance of an investigational new drug application by the U.S. Food…
The use of a computer-based program called BrainHQ led to significantly improved scores on cognitive tests among people with multiple sclerosis (MS), according to data from a small clinical trial in Nebraska. The study was led by Samantha Jack, PhD, as part of work she did as a…
Immunic Therapeutics has been notified of the intent to grant a U.S. patent covering the use vidofludimus calcium (IMU-838) in treating relapsing forms of multiple sclerosis (MS)Â at a daily dose of about 10 to 45 mg. That range covers the two IMU-838 doses shown to be…
Advanced Innovative Partners (AIP) has agreed to assist GlobeStar Therapeutics Corporation and SMI Healthcare in designing and running clinical trials to evaluate Project Amethyst, a patented triple combination of U.S.-approved medications aiming to prevent neurodegeneration due to multiple sclerosis (MS). This definitive agreement follows a…
Six months of treatment with foralumab, administered into the nose, led to decreases in microglial activity in five of six people with nonactive secondary progressive multiple sclerosis (SPMS) involved in an expanded access program. Microglia are resident immune cells in the brain believed to play a role in driving…
Treatment with the investigational therapy fenebrutinib significantly reduced the number of new inflammatory lesions visible on MRI scans in people with relapsing forms of multiple sclerosis (MS). Pharmacological data from the study suggest the anti-inflammatory experimental medication can get into the brain and spinal cord at levels high…
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…
Five of six people with secondary progressive multiple sclerosis (SPMS) treated with an experimental oral therapy called OCH saw no disease activity over six months in a small clinical trial. That’s compared with 0% of the SPMS patients given a placebo, according to new data presented by Tomoko Okamoto,…
A new under-the-skin formulation of Ocrevus (ocrelizumab) — administered in 10 minutes — 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…
Vidofludimus calcium (IMU-838), an investigational oral therapy being developed by Immunic Therapeutics for all types of multiple sclerosis (MS), has demonstrated neuroprotective effects in people with progressive forms of the disease, interim clinical trial data show. The experimental therapy was associated with reductions in neurofilament light chain (NfL)…
Six months of treatment with the experimental oral therapy vidofludimus calcium (IMU-838) led to significant reductions in a marker of nerve damage among people with relapsing-remitting multiple sclerosis (RRMS), according to a new analysis of data from a Phase 2 clinical trial. Previous data indicated the therapy significantly reduced…
The Accelerated Cure Project for Multiple Sclerosis and the Arab Board for Clinical Research have partnered with the Association of Diversity in Clinical Trials (AOD) to drive diversity and inclusion in clinical trials, including in those of multiple sclerosis (MS). The intent of the collaboration is to build…
Tiziana Life Sciences has started to recruit clinical sites for a Phase 2a clinical trial that will investigate its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS). The announcement follows a meeting with the principal investigators of the trial at Brigham and Women’s…
Over more than a decade of treatment with Lemtrada (alemtuzumab), relapse rates were low and about half of people with relapsing-remitting multiple sclerosis (RRMS) remained free of confirmed disability worsening, according to final results from the open-label TOPAZ clinical trial. “To our knowledge, this report represents the longest…
For older adults with multiple sclerosis (MS) who have highly active disease, most neurologists recommend starting treatment with a high-efficacy therapy, according to a survey study. Neurologists also generally agreed that patients with MS should continue on treatment into the latter decades of life, and that older MS patients…
FSD Pharma’s Lucid-21-302 — an oral treatment candidate known as Lucid-MS, for all types of multiple sclerosis (MS) — was found safe and well tolerated across multiple doses in healthy volunteers, according to interim data from a Phase 1 clinical trial. The newly released data are from the…