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…
clinical trials
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…
Lucid-MS, an oral small-molecule being developed by Quantum Biopharma for treating multiple sclerosis (MS), was found to be safe and well tolerated in healthy adult volunteers when given daily in a clinical study, according to the company’s latest CSR, or clinical study report. An earlier Phase 1…
Medications that can promote the repair of the myelin sheath — the protective coating around nerve cells in the body — may also help limit nerve damage in multiple sclerosis (MS), according to a new analysis of data from a small clinical trial testing an anticancer therapy called bexarotene…
Fenebrutinib significantly reduced the occurrence of new brain lesions with active inflammation in people with relapsing multiple sclerosis (MS), a Phase 2 clinical trial found. In the open-label extension portion of the FENopta trial (NCT05119569), disease activity “remained very low” for nearly one year, researchers wrote, with 98%…
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…
Vibration therapy, which provides mechanical stimulation to activate muscles and sensory receptors, may offer a promising new approach for easing fatigue in people with multiple sclerosis (MS), according to new data from a clinical trial. Patients who received vibration therapy reported reduced perceived fatigue and also showed significant gains…
In healthy adults, a single low dose of Immutep’s immunosuppressive candidate IMP761 continues to be safe and appears to reduce the activity of T-cells — immune cells that become overactive in multiple sclerosis (MS) and other autoimmune diseases. This is according to data from an ongoing Phase…
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…
More than 90% of relapsing-remitting multiple sclerosis (RRMS) patients who received Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium have not experienced confirmed disability worsening after nearly three years. That’s according to new data from the EMPhASIS Phase 2 clinical trial (NCT03846219) and its open-label extension (OLE)…
A CAR T-cell therapy from Iaso Biotherapeutics was tolerated well and led to marked improvements in disability for three people with progressive forms of multiple sclerosis (MS), according to early data from a Phase 1 clinical trial. After a single dose of equecabtagene autoleucel, patients saw rapid and…
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,…
Ambio Life Sciences has launched a clinical program to test ibogaine — an experimental, naturally occurring psychedelic — for neurodegenerative conditions such as multiple sclerosis (MS). The program aims to offer therapeutic support in a safe, medically supervised setting. Now open to the public following a soft launch…
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…
Almost two years of treatment with fenebrutinib — an investigational oral tablet for multiple sclerosis (MS) — helped patients with relapsing forms of the disease remain nearly free of relapses and disability progression. That’s according to new data from the open-label extension of FENopta (NCT05119569), a Phase…
Clemastine fumarate, an antihistamine, boosted disease progression by more than five times in adults with progressive multiple sclerosis (MS), according to data from a Phase 1/2 trial. “Likely nobody in the MS field, us included, knew about this potential [clemastine] toxicity until we collected the data presented here,” the…
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…
Stem cells from donated placentas appear safe and may help reduce symptoms of secondary progressive multiple sclerosis (MS), according to a small, open-label Phase 1 clinical trial involving five patients. “Our results suggest possible neuroprotective effects” from these stem cells, researchers wrote in “Cell therapy with placenta-derived mesenchymal…
Three months of daily supplements containing ellagic acid — an antioxidant found naturally in many fruits and plants — significantly reduced disability levels and eased fatigue, depression, and anxiety in people with multiple sclerosis (MS), according to a small clinical study from Iran. Indeed, the researchers noted a “statistically…
Quantum Biopharma intends to ask the U.S. Food and Drug Administration (FDA) this year for permission to start a Phase 2 clinical trial testing Lucid-21-302, its novel therapy for promoting myelin repair, in people with multiple sclerosis (MS). The company announced that it has completed dosing in a…
Injections of methotrexate into the spinal canal given every three months were safe and well tolerated, and helped adults with progressive forms of multiple sclerosis (MS) maintain stable disease levels for up to nine years. That’s according to data from a small, open-label Phase 1 clinical study (NCT02644044)…
Vidofludimus calcium, an experimental oral therapy from Immunic Therapeutics, reduced the risk of confirmed disability worsening and slowed brain shrinkage in people with progressive forms of multiple sclerosis (MS). That’s according to top-line data from CALLIPER (NCT05054140), a Phase 2 clinical trial testing a daily dose of…
The Patient-Centered Outcomes Research Institute (PCORI) has awarded the Cleveland Clinic $6.7 million to identify optimal treatment strategies for people with relapsing-remitting multiple sclerosis (RRMS). The funds will support the extension study of the multicenter DELIVER-MS (NCT03535298) clinical trial. The study is comparing two MS treatment approaches…
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 single 600 mg dose of Briumvi (ublituximab-xiiy) — instead of the approved 150 mg initial dose plus a 450 mg dose two weeks later — was well tolerated by adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from the ENHANCE Phase…
Kyverna Therapeutics’ CAR T-cell therapy candidate KYV-101 was deemed safe and well tolerated, and showed preliminary signs of efficacy, in people with progressive forms of multiple sclerosis (MS) in clinical testing. That’s according to data from two investigator-initiated Phase 1 trials, which enrolled individuals with secondary progressive…
Frexalimab, an experimental antibody-based medication, was well tolerated and maintained disease control over two years in adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from an open-label extension to a Phase 2 clinical trial (NCT04879628) in which frexalimab outperformed a placebo at reducing…
Clinical improvements in vision and cognition linked to the use of treatment candidate CNM-Au8 were correlated with signs of nerve cell repair and remyelination among people with relapsing-remitting multiple sclerosis (RRMS), according to new data. Remyelination is the process by which myelin, the fatty substance surrounding nerve cells…
Sanofi‘s oral BTK inhibitor tolebrutinib significantly delayed the onset of six-month confirmed disability progression compared with a placebo, by 31%, in people with nonrelapsing secondary progressive multiple sclerosis (SPMS). That’s according to recently published data from the HERCULES Phase 3 trial (NCT04411641), where the experimental therapy…