clinical trials

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…

Children and adolescents living with multiple sclerosis (MS) seem to benefit at least as much — and for some outcomes, significantly more — from Ocrevus (ocrelizumab) as from treatment with Gilenya (fingolimod), now the only MS therapy approved for pediatric patients in the U.S. That’s according to…

Treatment with equecabtagene autoleucel, known for short as eque-cel — Iaso Biotherapeutics‘ CAR T-cell therapy candidate for people with progressive forms of multiple sclerosis (MS) — was well tolerated and led to an easing of disability for five patients taking part in a Phase 1 clinical trial. The…

Combining the diabetes medication metformin and the antihistamine clemastine significantly increased myelin repair in people with relapsing-remitting multiple sclerosis (RRMS), according to results from a Phase 2 clinical trial. However, the effects were small, and participants showed no improvements in disability or visual function after six months of treatment.

People with relapsing-remitting multiple sclerosis (RRMS) who started fasting or adopted a ketogenic diet — one low in carbs and rich in fat — for 18 months showed reductions in risk factors for heart and metabolic disease that were similar to those who followed a standard healthy diet, according…

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…

For children and adolescents with multiple sclerosis (MS), receiving treatment with Copaxone (glatiramer acetate) or its generic formulations may reduce relapses by nearly threefold compared with Avonex (interferon beta-1a), according to data from a clinical trial. However, nearly half of patients on Copaxone and one-third of those…

High doses of vitamin D provide clinically modest but statistically significant benefits for adults with multiple sclerosis (MS), according to a meta-analysis of published clinical trials. The study found patients who took the supplement saw reductions in disability scores, relapses, and new lesion formation. Those who took vitamin D for…

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…

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…