clinical trials

Increasing the dose of the infusion therapy Ocrevus (ocrelizumab) does not provide additional benefit compared with the approved regimen in slowing disability progression for people with relapsing forms of multiple sclerosis (MS) or primary progressive MS. That’s according to final data from two global Phase 3b clinical…

The U.S. Food and Drug Administration (FDA) has given Pheno Therapeutics the green light to begin clinical testing of PTD802, the company’s oral lead treatment candidate for boosting myelin repair in people with multiple sclerosis (MS) and other neurological diseases. The experimental remyelination therapy aims to potentially…

Imviva Biotech is cleared to launch a basket Phase 1b trial testing its investigational off-the-shelf CAR T-cell therapy CTA313 in progressive multiple sclerosis (MS) and other B-cell-mediated autoimmune diseases. The announcement follows the clearance of the company’s investigational new drug (IND) application by the U.S. Food and Drug…

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Quantum Biopharma’s application seeking clearance to begin a Phase 2 trial testing Lucid-MS in people with multiple sclerosis (MS). Quantum said the FDA requested further information before clearing the investigational new drug (IND) application and…

First-line treatment with TG Therapeutics’ Briumvi (ublituximab) in clinical trials among people with relapsing forms of multiple sclerosis (MS) led to significantly fewer relapses, reduced signs of MRI disease activity, and better disability outcomes compared with those given the older drug Aubagio (teriflunomide) as their initial therapy.

Patient enrollment is complete in a Phase 2a clinical trial testing Tiziana Life Sciences‘ foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS), a form of multiple sclerosis (MS) with limited treatment options. “Reaching full enrollment in this landmark study is a testament to the strong…

Liberate Bio’s investigational CAR-M cell therapy LIB820 may help successfully eliminate disease-driving B-cells in autoimmune diseases such as multiple sclerosis (MS) without causing severe side effects, according to new preclinical data. The therapy is designed to genetically engineer two types of immune cells — monocytes and macrophages — within…

The U.S. Food and Drug Administration (FDA) has formally agreed that the design and planned analysis of an upcoming Phase 3 trial testing privosegtor in people with optic neuritis could support a future application seeking the therapy’s approval if the trial succeeds. Optic neuritis, or inflammation of the…

The first participant has been dosed in an investigator-initiated Phase 2 clinical trial testing Neuraly‘s experimental medication pegsebrenatide as a potential treatment for progressive forms of multiple sclerosis (MS). Called TAG-MS (NCT07497399), the study is being led by Ellen Mowry, MD, at…

A pilot clinical trial in the U.S. is enrolling people with relapsing-remitting multiple sclerosis (RRMS) to test Setpoint Medical’s implantable nerve stimulation device, which is designed to reduce inflammation and promote myelin repair. The trial (NCT06796504) is enrolling up to 60 people, ages 22-50, and will evaluate…

Ocrevus (ocrelizumab) delayed disability progression and worsening hand function among a large group of people with primary progressive multiple sclerosis (PPMS), including those who were older and had more advanced disease. The data, which come from the Phase 3 ORATORIO-HAND trial (NCT04035005), were presented by Jiwon Oh,…

The experimental drug fenebrutinib was shown to significantly outperform Aubagio (teriflunomide), an approved therapy, in reducing relapses and MRI markers of disease activity in people with relapsing forms of multiple sclerosis (MS). That’s according to new data from a pair of largely identical Phase 3 clinical trials…

Patient enrollment is complete in a Phase 3 trial testing a new formulation of Briumvi (ublituximab-xiiy), TG Therapeutics‘ multiple sclerosis (MS) medication for relapsing forms of the disease, that could be injected at home. The new formulation is designed to be given under the skin, or subcutaneously, every…

The first participant has been dosed in a Phase 1 clinical trial testing TNV262, an experimental therapy that Tenvie Therapeutics is developing as a potential treatment for multiple sclerosis (MS) and other conditions including obesity and cardiovascular disease. The Phase 1a/1b study will test single and multiple doses…

The European Medicines Agency (EMA) has granted PRIME designation to Oculis‘ experimental treatment privosegtor for optic neuritis, a condition commonly seen in people with multiple sclerosis (MS). Optic neuritis, marked by inflammation of the optic nerve that carries signals between the eyes and the brain, can…

Quantum Biopharma has officially filed with the U.S. Food and Drug Administration (FDA) for clearance to begin a Phase 2 clinical trial of Lucid-MS, a “first-in-class” oral therapy designed to halt the progression of multiple sclerosis (MS) by protecting myelin, or the protective sheath around nerves in…

Quantum Biopharma is preparing to seek permission in the U.S. to launch its planned clinical trial of Lucid-MS, an oral therapy that aims to slow myelin loss — which ultimately results in the neurological problems that drive multiple sclerosis (MS) — in people with the progressive…

IMP761, an experimental immunosuppressive therapy being developed by Immutep for multiple sclerosis (MS) and other autoimmune diseases, was well tolerated in healthy volunteers when given at single increasing doses. The findings come from the single-ascending dose portion of an ongoing Phase 1 clinical trial (NCT06637865), which tested…

The Accelerated Cure Project for Multiple Sclerosis (ACP) has received funding to help interpret and share findings from the DISCO-MS study, which examined whether older adults with stable multiple sclerosis (MS) could stop disease-modifying medications, to support more informed treatment decisions. The award comes through the Eugene Washington…

Innocare Pharma has dosed the first healthy volunteer in a clinical trial in China testing ICP-538, its oral treatment candidate for multiple sclerosis (MS) and other autoimmune diseases. The novel experimental therapy works by promoting the degradation of the VAV1 protein, essential for the function of T-cells and…

A clinical trial testing TG Therapeutics‘ CD20 inhibitor Briumvi (ublituximab-xiiy) in children with relapsing forms of multiple sclerosis (MS) will begin enrolling participants within the next few months, the developer announced, also unveiling details of the study’s design. The upcoming Phase 2/3 trial (NCT07220252) will run…

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to privosegtor, an experimental treatment from Oculis that aims to protect the vision of people experiencing acute optic neuritis. This condition, which involves inflammation of the optic nerve, is a common and often debilitating symptom of…

The balance between two immune signaling molecules — CXCL13 and BAFF — may help identify the hard-to-treat inflammation in the brain and spinal cord that’s thought to be a major driver of disability progression in multiple sclerosis (MS), a study found. The findings may help identify which patients are…

Quantum Biopharma has completed dosing in two toxicology studies requested by the U.S. Food and Drug Administration (FDA) that aim to support the launch of clinical studies of Lucid-MS, an experimental treatment for multiple sclerosis (MS) that’s designed to slow myelin loss. The 180-day toxicity and toxicokinetic…

In people with progressive multiple sclerosis (MS), treatment with the antioxidant lipoic acid did not improve walking or lessen other symptoms, such as fatigue, but it did show signs of slowing brain atrophy, or the loss of brain tissue. According to the researchers, this suggests possible positive biological…

A clinical trial testing whether music therapy can make botulinum toxin injections for spasticity more tolerable for people with multiple sclerosis (MS) and other neurological conditions is enrolling participants at Clermont-Ferrand University Hospital in France.  The study’s protocol was published in PLOS One, in a paper titled, “…

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…

Lynk Pharmaceuticals has received the green light from the U.S. Food and Drug Administration (FDA) to begin clinical trials of its investigational oral therapy LNK01006, which is being developed for multiple sclerosis (MS) and other neuroinflammatory diseases. “We look forward to advancing this promising molecule into human clinical…

A Phase 2 clinical trial testing PIPE-307, an experimental therapy designed to support myelin repair in people with multiple sclerosis (MS), has failed to meet its primary or secondary efficacy goals. The U.S.-based VISTA trial (NCT06083753) enrolled more than 180 adults with relapsing-remitting MS (RRMS). Participants received…

A clinical trial is now recruiting participants to test whether an experimental vaccine for the Epstein-Barr virus (EBV) is safe and may help reduce disease activity in people with multiple sclerosis (MS). The Phase 2 study (NCT06735248) aims to enroll 180 adults, ages 18 to 55, with…