I wrote in the summer about changing the disease-modifying therapy (DMT) for my multiple sclerosis (MS). I’ve familiarized myself with the available DMTs, and I plan to ask my neurologist for her recommendation next week and then make a decision. As I’ve researched my options, I’ve become interested…
Trial recruitment
Scientists at Case Western Reserve University (CWRU) in Ohio will use a new $2.5 million donation from the Thomas F. Peterson Jr. Charitable Trust to develop therapeutic strategies for multiple sclerosis (MS) and other neurological diseases. The commitment will support Paul Tesar, PhD, a CWRU professor and director of the…
Enrollment is complete for the randomized part of ENHANCE, a large clinical trial testing a new dosing schedule for Briumvi (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (MS), developer TG Therapeutics announced. This part of the Phase 3b ENHANCE study (NCT05877963) is specifically testing whether…
Bionxt Solutions has launched the final animal study needed to prepare for human testing of BNT23001, its sublingual version of cladribine, in people with multiple sclerosis (MS). The 15-day dosing optimization study will compare Bionxt’s thin-film formulation with the approved tablet version of cladribine, sold as Mavenclad, in…
The first patient has been dosed in a Phase 1 clinical trial of Autolus Therapeutics‘ experimental CAR T-cell therapy, obecabtagene autoleucel (obe-cel), in people with progressive forms of multiple sclerosis (MS) who have failed to respond to existing treatments. Dosing took place at University College London Hospitals NHS…
Enrollment is complete for a Phase 2 trial testing Zenas Biopharma’s obexelimab in people with relapsing forms of multiple sclerosis (MS). The trial, MoonStone (NCT06564311), is investigating how safe obexelimab is when given as weekly under-the-skin (subcutaneous) injections, and how well it works in approximately 93 participants…
A global clinical trial has been launched to evaluate the oral therapy candidate BMS-986368 for treating spasticity — muscle stiffness and spasms — in people with multiple sclerosis (MS). The Phase 2 study (NCT06782490), called BALANCE-MSS-1, will enroll about 200 adults with MS who have experienced spasticity…
Two of three groups — one composed of people with progressive forms of multiple sclerosis (MS), and the other comprising healthy volunteers — have been fully enrolled in a Phase 1b clinical trial that’s testing a new anti-inflammatory drug being developed by Contineum Therapeutics. The Phase 1b…
The first person with multiple sclerosis (MS) has been successfully imaged in a clinical trial evaluating a new positron emission tomography (PET) tracer designed to detect changes in myelin loss, or demyelination. The Phase 1 study (NCT04699747), a joint effort between Quantum Biopharma and Massachusetts…
A multicenter Phase 2a clinical trial testing foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has begun dosing patients at Weill Cornell Medicine Multiple Sclerosis Center in New York. The Phase 2a study (NCT06292923) is assessing the safety and efficacy of Tiziana Life Sciences‘ therapy,…
Enrollment is now complete in the twin Phase 3 clinical trials testing Immunic Therapeutics‘ oral small molecule vidofludimus calcium in adults with relapsing forms of multiple sclerosis (MS). ENSURE-1 (NCT05134441) has enrolled 1,121 patients and ENSURE-2 (NCT05201638) has enrolled 1,100 patients at more than 100…
Quantum Biopharma has signed an agreement with a global pharmaceutical contract research organization to continue advancing Lucid-21-302, its experimental therapy for promoting myelin repair with multiple sclerosis (MS). The collaboration will help the company put together an investigational new drug (IND) application for the therapy, which is also…
Bionxt Solutions is getting ready to launch a pilot clinical trial to test BNT23001, its sublingual (under-the-tongue) version of cladribine to treat multiple sclerosis (MS). The treatment would be an alternative to Mavenclad, the approved tablet form of cladribine. Bionxt‘s thin-film formulation quickly dissolves under the tongue,…
A Phase 4 observational study called ENABLE is enrolling adults with relapsing forms of multiple sclerosis (MS) across the U.S. to better understand the safety, tolerability, and efficacy of Briumvi (ublituximab-xiiy) in the real world. At least 500 patients are expected to enter ENABLE (NCT06433752) at some…
Quantum Biopharma is partnering with researchers at Massachusetts General Hospital in Boston on a clinical study to test a positron emission tomography (PET) tracer for monitoring changes in myelin content in people with multiple sclerosis (MS). The Phase 1 study (NCT04699747) is recruiting healthy adults and people…
The AdventHealth Neuroscience Institute is recruiting patients for a Phase 1b clinical trial testing IDP-023, an off-the-shelf cell-based treatment that Indapta Therapeutics is developing for primary or nonactive secondary progressive multiple sclerosis (MS). The company delayed the study’s expected launch in the second half of last…
Four more people with nonactive secondary progressive multiple sclerosis (SPMS) have received foralumab nasal spray — Tiziana Life Sciences’ therapy candidate for SPMS — via an expanded access program, the biotechnology company announced. That program allows patients who do not qualify for an ongoing Phase 2a clinical…
A Phase 2 clinical trial is currently recruiting adults with relapsing types of multiple sclerosis (MS) to investigate Zenas Biopharma’s experimental therapy obexelimab as a weekly subcutaneous, or under-the-skin, injection, the company has announced in a press release. The study, called MoonStone (NCT06564311), is open to…
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has cleared Pheno Therapeutics to initiate a first-in-human Phase 1 clinical trial to test its oral candidate PTD802 in healthy volunteers. The therapy is a selective small molecule antagonist, or inhibitor, of the GPR17 receptor and is designed to restore…
Patient enrollment has been completed ahead of schedule in a Phase 2 clinical trial evaluating Contineum Therapeutics‘ PIPE-307, an oral therapy aiming to restore myelin — a process known as remyelination — in people with relapsing-remitting multiple sclerosis (RRMS), the company announced. The VISTA trial (NCT06083753), launched…
A Phase 1 clinical trial that is investigating a new vaccine against the Epstein-Barr virus (EBV), a well-established risk factor for developing multiple sclerosis (MS), in healthy volunteers has dosed its first participant. The vaccine, called MDX2201, is being developed by Modex Therapeutics, an Opko Health company,…
Tiziana Life Sciences is expanding its Phase 2 clinical trial testing foralumab nasal spray for the treatment of nonactive secondary progressive multiple sclerosis (SPMS), with six additional clinical sites across the northeastern region of the U.S. The new sites, all at top U.S. institutions, bring together leaders in…
An artificial intelligence (AI)-based tool called Muse aims to accelerate drug development by optimizing clinical trial patient recruitment. The tool, designed as part of a collaboration among Formation Bio, OpenAI, and Sanofi, is designed to be implemented across a range of areas. Sanofi will first put it…
SetPoint Medical is planning to launch a clinical trial next year to investigate its nerve stimulator device, intending to support myelin repair, in people with relapsing-remitting multiple sclerosis (RRMS). The announcement comes after U.S. Food and Drug Administration (FDA) approval of an investigational device exemption, allowing the…
A clinical trial is evaluating whether combining a cognitive rehabilitation program with a virtual reality (VR)-based aerobic exercise regimen will improve learning and memory in people with multiple sclerosis (MS) and motor disability. Researchers expect the approach will show cognitive benefits via positive effects on a brain region called…
A specific epigenetic marker, or a chemical modification in DNA that alters gene activity, may explain why adult oligodendrocyte progenitor cells respond differently to therapies aiming to restore myelin than their neonatal counterparts, a study reports. The modification, called a lysine eight acetylation on histone H4, helps to regulate…
TG Therapeutics plans to soon launch a Phase 1 clinical trial to investigate the CAR T-cell therapy azercabtagene zapreleucel, or azer-cel, in people with progressive forms of multiple sclerosis (MS). The announcement comes after the U.S. Food and Drug Administration (FDA) cleared TG’s…
PIPE-307, an experimental oral therapy that’s currently in Phase 2 testing for relapsing-remitting multiple sclerosis (RRMS), was shown to promote myelin repair in a mouse model of multiple sclerosis (MS). The preclinical findings were published in PNAS, in the study “Targeting the muscarinic M1 receptor…
A PhD student at the UMass Chan Medical School will use funding from a newly awarded fellowship to advance his research into the mechanisms used by cells to repair myelin, the protective sheath around nerve cells that’s damaged in multiple sclerosis (MS) and other demyelinating conditions. The ongoing…
A team of Kessler Foundation researchers has been granted more than $700,000 by the National Multiple Sclerosis Society for work that seeks to better understand the brain networks associated with primary fatigue in people with multiple sclerosis (MS). The grant, totaling $722,602, was awarded to Glenn Wylie, PhD,…