clinical trials

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…

Genentech‘s experimental oral therapy fenebrutinib has become the first Bruton’s tyrosine kinase (BTK) inhibitor to show positive Phase 3 results in both relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS), the company announced. In what Genentech called “unprecedented results,” two late-stage trials testing…

SUDO-550, an oral TYK2 inhibitor being developed by Sudo Biosciences, was found to be safe, well-tolerated, and to fully reach the brain in a first-in-human clinical trial involving healthy volunteers, according to clinical trial results. The Phase 1 clinical trial, which began dosing late last year, also showed…

Ultraviolet light therapy may help reduce inflammation and disease severity in people with multiple sclerosis (MS), according to data from a small Phase 1 clinical trial. Researchers used Octave’s MS Disease Activity (MSDA) scale — a clinically validated test for monitoring MS disease activity — and found the majority…

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…

Obexelimab, a therapy Zenas Biopharma is developing for a range of autoimmune diseases, almost completely prevented the formation of new inflammatory lesions in adults with relapsing forms of multiple sclerosis (MS) in the first three months of a clinical trial. That’s according to data from the first part…

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…

As a law student in the Czech Republic, Jana Hlavacova specialized in international law and international relations, but a multiple sclerosis (MS) diagnosis led her to shift her professional focus. Applying her legal expertise to her work at the Czechia Ministry of Health, she now helps shape healthcare policy…

The U.S. Food and Drug Administration (FDA) has given Tr1x the green light to launch a first-in-human clinical trial of TRX319, a cell therapy candidate designed to restore immune balance in people with progressive forms of multiple sclerosis (MS). With FDA clearance now granted for its investigational new…

Quantum Biopharma says it is closer to initiating a Phase 2 clinical trial — one involving people living with multiple sclerosis (MS) — to test its experimental therapy Lucid-MS after receiving the final reports from two toxicology studies requested by the U.S Food and Drug Administration (FDA). The…

Zenas Biopharma has acquired global rights to develop the BTK inhibitor orelabrutinib to treat multiple sclerosis (MS) and other diseases. The deal with orelabrutinib’s developer, Innocare Pharma, includes rights to two other investigational therapies. Zenas will pay Innocare up to $100 million in cash and up to…

Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium continues to show a significant effect on disability worsening in people with progressive forms of multiple sclerosis (MS), even in those without signs of active inflammation in the brain, a group with limited treatment options. That’s according to new data…

Increasing the dose of Ocrevus (ocrelizumab) by two- or threefold, depending on a person’s weight, did not provide additional benefit in slowing disability progression compared with the standard regimen in people with primary progressive multiple sclerosis (PPMS). That’s according to top-line data from the Phase 3b GAVOTTE…