Nasal spray cut a brain inflammation sign in progressive MS, maker says

A nasal spray containing an antibody called foralumab met the two main goals of a 12-week trial in people with a slowly worsening form of multiple sclerosis (MS), its developer Tiziana Life Sciences said on November 3, 2026.¹ The spray was safe and well tolerated at both doses tested, and the lower dose reduced a brain-scan sign of inflammation compared with a placebo (a dummy spray).¹ The higher dose did not show a statistically clear difference from placebo on that scan measure.¹

The results are “topline”, meaning an early summary released by the company. They have not been published in a journal, and the trial’s public registry record listed no posted results.² Tiziana said it plans to talk with the US Food and Drug Administration (FDA) about next steps.¹

What happened

The trial, called INFORM-MS, enrolled 48 adults at 8 sites in the United States.³ People were randomly assigned to a dummy spray (18 people), a 50-microgram dose of foralumab (19 people) or a 100-microgram dose (11 people).³ It was double-blind, meaning neither the participants nor the study staff knew who got what.³ Treatment lasted 12 weeks, given in four back-to-back three-week cycles.³ All 48 participants completed treatment.¹

It was a Phase 2a trial, an early mid-stage test meant to check safety and look for signs that a drug does something in the body before larger trials.² Its registry record, first posted in March 2024, lists Tiziana as the sponsor, a start date in November 2023 and an estimated enrollment of 54 people.²

The kind of MS being tested

MS is a long-term disease in which inflammation damages tissue in the brain and spinal cord.¹ Most people first have relapsing-remitting MS, with flare-ups of new or worsening symptoms called relapses.¹ Over time, some develop secondary progressive MS, in which disability slowly worsens even without relapses.¹

This trial focused on people with non-active secondary progressive MS: no recent relapses and no new signs of disease activity on MRI scans, even though disability may keep getting worse.¹ Treatment options for this group are particularly limited.¹ Tiziana says there are no FDA-approved therapies specifically for it.³

Foralumab is a fully human antibody, a lab-made immune protein, that targets CD3, a protein on the surface of immune cells called T cells.³¹ It is designed to turn down T cells that promote inflammation and boost T cells that help keep it in check.¹

The evidence so far

Brain scans

One main goal was a change in the activity of microglia, the brain’s own immune cells, which are involved in brain inflammation.¹ The trial measured this with a PET scan, a type of imaging that uses a small amount of a tracer to show where certain cells are active.³ After 12 weeks, the 50-microgram group showed a statistically significant drop in this signal compared with placebo, according to the company (p=0.0168, a measure of how likely the result is due to chance).³ The 100-microgram group did not show a statistically significant difference from placebo.¹

Tanuja Chitnis, the trial’s principal investigator and a professor of neurology at Harvard Medical School and Brigham and Women’s Hospital, said the scan result at the lower dose “closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a controlled setting.”³

That earlier program gave foralumab outside a trial to 10 people with this form of MS. In it, the treatment appeared to reduce microglia activity in 80% of patients and ease fatigue in 70%.¹ That program had no placebo group, which is why the new trial was set up to compare against a dummy spray.¹

Safety

The other main goal was safety. No serious side effects linked to foralumab were reported.¹ The most common reported problems were headaches, falls, a stuffy nose and a runny nose.¹ “Safety and tolerability were favorable across both doses,” Chitnis said.¹

Fatigue

Fatigue was a secondary measure, tracked with a questionnaire called the Modified Fatigue Impact Scale.³ Over 12 weeks, average scores fell by 6.17 points on the lower dose and 7.18 points on the higher dose, compared with 3.12 points on the dummy spray.¹ Each spray group’s drop was statistically significant compared with its own starting scores, but a significant difference against placebo was not established.¹ The company described the change of more than 4 points as clinically meaningful, based on an earlier published threshold.³

What it does not show yet

• No effect on disability yet. The company said it did not see any change on the Expanded Disability Status Scale, a standard MS disability score, over the 3 months of treatment.³ The trial was not designed to reliably detect differences in clinical outcomes between groups.¹
• Mixed dose results. Only the lower dose cleared the bar on the scan goal.¹ The higher-dose group was also the smallest, at 11 people.³ The sources do not explain why the higher dose did not show a clear difference.
• Fatigue is an open question. Fatigue improvements were measured against each group’s own starting point, not shown to beat placebo.¹
• Small and short. Forty-eight people over 12 weeks is too small and too brief to show long-term benefit or rarer side effects.³
• Not yet reviewed. The figures come from the company and have not been through peer review. The registry record also lists a nasal symptom score among its main outcomes, which the company’s summary did not report.²³

Who is behind it

Tiziana Life Sciences, a biotechnology company listed on the Nasdaq exchange, sponsored and paid for the trial.³² The company says it developed nasal foralumab for brain and nerve diseases based on work in the laboratory of Howard L. Weiner, a Harvard neurology professor and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.³

The comments on the results quoted in the company’s release came from its chief executive and from doctors who ran the study. Besides Chitnis, Tarun Singhal, who directs a brain-imaging program at Brigham and Women’s Hospital, said the findings “align with what we have observed in the expanded access setting.”³ No independent experts were quoted in the sources.

Ivor Elrifi, Tiziana’s chief executive, said:

We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation.

³

How it fits the field

Many MS treatments target relapses and new inflammation seen on MRI scans, which can help people with active disease.¹ People with the non-active progressive form, by definition, show neither, leaving fewer options.¹ Foralumab’s approach is to target a slower, lingering inflammation tied to microglia instead.¹ Tiziana is also testing the spray in other brain and nerve diseases, including ALS.³

What to watch next

• The outcome of Tiziana’s planned talks with the FDA about how to develop foralumab further for this form of MS.¹
• Full results, including the nasal symptom measure listed in the registry, posted to the registry or published in a journal.²
• Whether a larger, longer trial is designed to test effects on disability and fatigue against placebo.¹