Nasal MS therapy moves closer to results after final patient dosed

A Phase 2a clinical trial testing Tiziana Life Sciences‘ experimental intranasal therapy foralumab in people with nonactive secondary progressive multiple sclerosis (SPMS) has begun dosing its final participant.

The INFORM-MS trial (NCT06292923) is evaluating the safety, tolerability, and efficacy of foralumab versus a placebo in up to 48 adults. The trial is running at seven clinical sites in the U.S., and dosing is underway across multiple sites.

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Trial results expected later this year

Top-line results are expected later this year and are planned to 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.

“We are thrilled to reach this important milestone in our Phase 2 program,” Ivor Elrifi, Tiziana’s CEO, said in a company press release. “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.”

Nonactive SPMS is a form of multiple sclerosis (MS) that can develop after relapsing-remitting MS (RRMS). It is marked by gradually worsening disability, without relapses or new signs of disease activity on MRI scans.

While more than 20 disease-modifying therapies are approved for relapsing forms of MS, including RRMS, options are much more limited when patients transition to nonactive SPMS. Only mitoxantrone is approved to treat these patients, and it is rarely used due to side effects and an increased risk of serious complications.

Foralumab is an antibody designed to target CD3, a protein found on the surface of T-cells, which are immune cells that contribute to MS-related inflammation and damage. By binding to CD3, the therapy is expected to suppress the activity of inflammatory T-cells while boosting regulatory T-cells, which help keep immune responses in check.

The experimental therapy is being evaluated in an open-label expanded access program (NCT06802328), which gives some people with nonactive SPMS access to the medication outside clinical trials.

Early access data showed stable disability

Data from 14 patients showed that disability levels remained stable or improved after about three years of follow-up for most patients, with only one patient experiencing sustained worsening in disability scores. About two-thirds of patients also showed clinically meaningful improvements in fatigue.

Early data suggest foralumab may reduce microglial activity, which is believed to contribute to disease progression in nonactive SPMS. PET imaging data from 10 patients in the expanded access program showed that 80% experienced reductions in microglial activity after six months of treatment.

The INFORM-MS trial is designed to test these findings in a larger, placebo-controlled study. Participants were randomly assigned to receive one of two doses of intranasal foralumab — 50 or 100 micrograms per dose — or a placebo for about three months. Treatment is being given in three-week cycles — three times a week for two weeks followed by one week off.

Participants who complete the randomized phase may then have the option to receive foralumab for an additional six months to study its longer-term effects.

The study’s main goal is to see whether foralumab is safe and whether it can reduce microglial activity. Secondary and exploratory goals include changes in standard measures of disability and fatigue, as well as changes in inflammatory brain lesions and brain volume.

“Intranasal foralumab represents a promising and innovative therapeutic strategy for patients with non-active secondary progressive MS,” said Tanuja Chitnis, MD, a neurologist at Mass General Brigham Neuroscience Institute and principal investigator in the trial. “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.”