Experimental MS therapy reduces brain inflammation in Phase 2 trial

A lower dose of the experimental therapy foralumab significantly reduced a marker of brain inflammation in people with nonactive secondary progressive multiple sclerosis (SPMS), according to top-line results from a Phase 2 clinical trial.

The 12-week study, called INFORM-MS (NCT06292923), met both its main goals. Both doses of foralumab were safe and well tolerated, while the lower dose significantly reduced the activity of microglia, immune cells involved in brain inflammation, compared with a placebo.

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Oct. 23, 2026 News by Michela Luciano, PhD

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Early findings suggest foralumab may help reduce fatigue

People receiving either dose of foralumab also had statistically significant reductions in fatigue, a common symptom of multiple sclerosis (MS), compared with their own scores before treatment. However, the study was not designed to reliably detect differences in fatigue between the foralumab and placebo groups.

Tiziana Life Sciences, which is developing foralumab, plans to discuss the results and next steps for the therapy’s development in nonactive SPMS with the U.S. Food and Drug Administration (FDA).

“These data, together with the accumulating real-world evidence from our expanded access program in [nonactive SPMS] patients, as well as emerging data from our current trials in [other neurological diseases], positions us well as we advance foralumab to the next stage of development,” Ivor Elrifi, CEO of Tiziana, said in a company press release.

MS is a chronic disease in which inflammation damages tissue in the brain and spinal cord. Most people initially develop relapsing-remitting disease (RRMS), which causes periods of new or worsening symptoms called relapses. Over time, some people develop SPMS, in which disability gradually worsens even without relapses.

Some people with SPMS continue to have occasional relapses or show new inflammatory activity on MRI scans. Treatments that target this activity may help them. Others have nonactive SPMS, meaning they have no recent relapses or new signs of disease activity on MRI scans, even though disability may continue to worsen. Treatment options for this form of MS remain particularly limited.

Foralumab is an antibody-based therapy given as a nasal spray. It targets CD3, a protein on the surface of immune cells called T cells. The treatment is designed to reduce the activity of T cells that promote inflammation while increasing the activity of T cells that help control it.

Expanded access program showed promising results

Earlier results from an expanded access program involving 10 people with nonactive SPMS suggested that foralumab reduced the activity of microglia, the brain’s resident immune cells, in 80% of patients. The therapy also eased fatigue in 70% of them.

To further investigate these findings in a placebo-controlled study, Tiziana sponsored the INFORM-MS trial, which tested two doses of foralumab (50 or 100 micrograms) against a placebo in 48 adults with nonactive SPMS.

One of the study’s main goals was to evaluate how safe and well tolerated foralumab was. All 48 participants completed treatment, and no serious adverse events related to foralumab were reported. The most commonly reported adverse events included headaches, falls, nasal congestion, and runny nose.

“Safety and tolerability were favorable across both doses,” said Tanuja Chitnis, MD, principal investigator of the INFORM-MS trial at Harvard Medical School.

The study’s other main goal was to measure changes in microglial activity. The lower, 50-microgram dose significantly reduced this activity compared with a placebo. However, the higher, 100-microgram dose did not show a statistically significant difference compared with a placebo.

“The primary imaging endpoint on [microglia activity] in the 50 [microgram] nasal foralumab treatment arm from the INFORM-MS study closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a controlled setting,” Chitnis said.

Fatigue improvements seen with both treatment doses

The Phase 2 study was not designed to reliably detect differences in clinical outcomes between treatment groups. However, Tiziana reported meaningful improvements in fatigue among patients receiving foralumab, as measured by the Modified Fatigue Impact Scale (MFIS).

Over 12 weeks, average fatigue scores fell by 6.17 points with the lower dose and 7.18 points with the higher dose, compared with 3.12 points in the placebo group. The reductions were statistically significant compared with each foralumab group’s own starting scores, but a significant difference versus placebo was not established.

Tiziana noted that no therapies are FDA-approved specifically for nonactive SPMS. “This clinical effect was notable. We consider these findings as encouraging evidence of the biological activity of nasal foralumab in this MS population where at present there are no approved treatments for these patients,” Chitnis said.

Tarun Singhal, MD, an associate professor of neurology at Harvard Medical School, added that the findings “validate the therapeutic potential of intranasal foralumab in non-active secondary progressive MS.”

“Seeing a statistically significant reduction in microglial activation …, together with a clinically significant difference in fatigue in both foralumab doses, is highly encouraging,” Singhal said. “These findings align with what we have observed in the expanded access setting and reinforce the rationale for advancing this novel approach.”

Tiziana is also planning to test foralumab in combination with anti-CD20 therapy in people with RRMS who show inadequate responses to anti-CD20 therapy alone.