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…
Trial recruitment
TG Therapeutics has started enrolling participants in a Phase 3 trial to test a new version of Briumvi (ublituximab-xiiy) that can be injected at home. This change could offer greater convenience and flexibility for people with relapsing forms of multiple sclerosis (MS). The new formulation is given…
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…
An oral treatment that could repair nerve damage in multiple sclerosis (MS) is a step closer to a Phase 2 clinical trial. Quantum Biopharma signed a manufacturing agreement covering an oral formulation of its investigational small molecule Lucid-21-302, also known as Lucid-MS, as it prepares for the Phase 2…
A new positron emission tomography (PET) tracer may help determine the extent of nerve fiber loss in multiple sclerosis (MS) lesions, something that can’t be identified with conventional MRI imaging, according to a new study. Researchers think the new imaging tech could help track the efficacy of experimental therapies…
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…
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,…
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…
A multicenter Phase 2a clinical trial testing Tiziana Life Sciences’ foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has dosed the first patients enrolled at Yale MS Center. The Phase 2a study (NCT06292923) is assessing the treatment’s safety and efficacy against a placebo in…
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…
Bionxt Solutions is preparing to launch a pilot clinical trial to compare BNT23001, its new sublingual, or under-the-tongue, formulation of cladribine, to the original medication Mavenclad to treat multiple sclerosis (MS). Mavenclad is a tablet formulation of cladribine that’s approved for adults with relapsing forms of MS. The…
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…
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…
Indapta Therapeutics will launch a Phase 1 clinical trial in the U.S. in the second half of 2024 to explore its cell-based therapy IDP-023 in people with progressive forms of multiple sclerosis (MS). The announcement follows the U.S. Food and Drug Administration’s (FDA) clearance of the company’s investigational…
Three innovative projects aimed at addressing unmet needs in multiple sclerosis (MS) and fostering new perspectives on the disease have received incubator grants from the nonprofit MS Australia. Totaling AU$74,813 (or about $48,700), the grants will support one-year projects that focus on MS social needs, disease biomarkers, and…
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…
The U.S Food and Drug Administration (FDA) authorized an investigational new drug application from Synaptogenix, clearing the company to launch a clinical trial to test whether its lead candidate bryostatin-1 can prevent cognitive decline in people with multiple sclerosis (MS). The open-label, Phase 1 clinical trial (NCT06190912),…
A large clinical trial to test online programs for treating fatigue in people with multiple sclerosis (MS) will launch in the U.S. in the coming months. The study — the largest of its kind — will be funded by a nearly $4.5-million grant from the U.S. Department of…
Researchers at Stanford University have partnered with Kyverna Therapeutics to conduct an investigator-initiated clinical trial of the company’s cell-based therapy, KYV-101, in people with progressive forms of multiple sclerosis (MS) without relapses. The open-label Phase 1 trial (NCT06138132) will take place at the Stanford Multiple Sclerosis…
A small clinical trial in Texas is testing whether a noninvasive magnetic brain stimulation procedure can ease the symptoms of overactive bladder in adults with multiple sclerosis (MS). The randomized Phase 2 study (NCT06072703) is ongoing at Houston Methodist Hospital, and is recruiting about 29 women with stable…
Sudo Biosciences has secured an additional $30 million in funding to support the development of two TYK2 inhibitor therapies for multiple sclerosis (MS) and other neurological and skin conditions — and now is aiming to launch clinical trials later this year. With a second close of its Series…
Enrollment is nearly complete in a clinical trial of the Scone neuromodulation device in treating neurogenic, or overactive, bladder due to multiple sclerosis (MS), stroke, or spinal cord injury, SpineX, its developer, announced. Currently, 95 adult patients (more than 80% of planned total), ages 18 to…
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.
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…
A global Phase 2 clinical trial investigating the oral therapy vidofludimus calcium (IMU-838) in people with progressive forms of multiple sclerosis (MS) has reached full enrollment, the treatment’s developer, Immunic Therapeutics, reports. Called CALLIPER (NCT05054140), the trial is assessing whether the neuroprotective effects of vidofludimus calcium seen in…
People with multiple sclerosis (MS) living in the U.K. who identified as South Asian reported their first symptoms at a significantly younger age than self-reported white and Black individuals, according to preliminary data from the ADAMS project. ADAMS, which stands for the genetic Association study of individuals from…
To address knowledge gaps and avoid duplicate efforts in the lab and in trials, 10 multiple sclerosis (MS) organizations from around the world have committed to a single global research strategy to find a cure for the progressive neurodegenerative disorder. The nonprofits, with headquarters in countries ranging from the…