Two experimental multiple sclerosis treatments are moving into advanced clinical trials with a fundamentally different approach than existing MS drugs: instead of just suppressing the immune system, they aim to repair the myelin sheath that MS damages. One therapy targets myelin repair directly, while the other focuses on reducing inflammation in the brain itself. Both could offer hope to MS patients who have limited treatment options, particularly those with progressive forms of the disease.

What Is Myelin, and Why Does MS Damage It?

Myelin is the protective coating around nerve fibers in the brain and spinal cord. In multiple sclerosis, the immune system mistakenly attacks this coating, causing it to break down. This damage disrupts communication between the brain and the rest of the body, leading to symptoms like fatigue, mobility problems, and cognitive changes. Most existing MS drugs work by calming the immune system, but they don't repair the damage that's already been done. The new therapies take a different path: they're designed to either restore myelin directly or reduce the brain inflammation that contributes to ongoing nerve damage.

Which MS Treatments Are Entering Clinical Trials?

Quantum BioPharma's experimental therapy, called LUCID-MS, is advancing into Phase 2 clinical trials after showing a favorable safety profile in healthy volunteers. The company submitted an Investigational New Drug application to the FDA in April 2026, clearing the way for patient-focused studies. LUCID-MS is designed to target demyelination and protect or restore myelin integrity, potentially offering a first-in-class approach that directly addresses myelin loss rather than relying solely on immune suppression.

Meanwhile, Tiziana Life Sciences is testing an intranasal therapy called foralumab in people with nonactive secondary progressive multiple sclerosis (SPMS), a form of MS marked by gradually worsening disability without relapses. The INFORM-MS trial has just completed dosing its final participant, with top-line results expected later this year. Foralumab works by targeting CD3, a protein on T-cells, to suppress inflammatory immune cells while boosting regulatory T-cells that help control immune responses.

What Do Early Results Show?

LUCID-MS demonstrated a favorable safety profile in Phase 1 studies conducted in healthy volunteers, supporting its progression to patient-focused trials. The therapy was generally well tolerated, a critical first step for any new drug.

Foralumab's early access data is more detailed. Among 14 patients with nonactive SPMS who received the therapy for about three years, disability levels remained stable or improved for most, with only one patient experiencing sustained worsening in disability scores. About two-thirds of patients also showed clinically meaningful improvements in fatigue. Additionally, PET imaging data from 10 patients showed that 80% experienced reductions in microglial activity after six months of treatment. Microglia are brain cells believed to contribute to disease progression in nonactive SPMS.

Why Is This Important for MS Patients?

Treatment options for progressive forms of MS are severely limited. While more than 20 disease-modifying therapies are approved for relapsing forms of MS, only mitoxantrone is approved for nonactive SPMS, and it is rarely used due to side effects and serious complications. These new therapies could fill a critical gap for patients whose disease continues to worsen despite existing treatments.

The focus on myelin repair and microglial activity represents a shift in how researchers think about MS treatment. Rather than simply quieting the immune system, these approaches aim to address the underlying mechanisms of nerve damage and brain inflammation that drive disability progression.

How to Stay Informed About MS Clinical Trials

• Check ClinicalTrials.gov: Search for MS trials in your area or those recruiting remotely. The INFORM-MS trial identifier is NCT06292923, and you can find detailed eligibility criteria and contact information for participating sites.
• Talk to Your Neurologist: Your MS specialist can discuss whether you might be a candidate for emerging therapies and help you understand the potential benefits and risks of participating in clinical research.
• Join MS Communities: Patient advocacy organizations and online MS communities often share updates about new trials and can connect you with others who have participated in research studies.

When Will These Therapies Be Available?

LUCID-MS is in early-stage development, with Phase 2 trials now underway. It will likely take several years before the therapy could potentially reach patients, assuming the trials continue to show safety and efficacy.

Foralumab's timeline is somewhat closer. Top-line results from the INFORM-MS trial are expected later this year and will be presented at the joint ACTRIMS-ECTRIMS meeting in October in Toronto, Canada. ACTRIMS and ECTRIMS are major MS research organizations in the Americas and Europe. Participants who complete the randomized phase of the trial may have the option to receive foralumab for an additional six months to study its longer-term effects.

"We are thrilled to reach this important milestone in our Phase 2 program. The successful initiation of dosing in all patients underscores the strong execution by our clinical teams and the enthusiasm from investigators and patients for this novel intranasal approach," said Ivor Elrifi, CEO of Tiziana Life Sciences.

Ivor Elrifi, CEO, Tiziana Life Sciences

"Intranasal foralumab represents a promising and innovative therapeutic strategy for patients with non-active secondary progressive MS. We are encouraged by the smooth initiation of dosing across sites and look forward to evaluating its impact on microglial activation, and then further clinical outcomes during the open label extension in this underserved patient population," explained Tanuja Chitnis, MD, a neurologist at Mass General Brigham Neuroscience Institute and principal investigator in the trial.

Tanuja Chitnis, MD, Neurologist at Mass General Brigham Neuroscience Institute

These two therapies represent a meaningful shift in MS research, moving beyond immune suppression toward repair and neuroprotection. For patients with progressive MS who have few options, the results of these trials could reshape treatment possibilities in the coming years.