A new clinical study has reported encouraging results for Foralumab, an experimental nasal treatment designed to reduce inflammation in patients with progressive multiple sclerosis (MS). The findings suggest that this innovative approach could offer new possibilities for managing certain forms of the disease.
Tiziana Life Sciences, a biotechnology company developing immunomodulatory therapies, announced positive preliminary results from its Phase 2a clinical trial, known as INFORM-MS.
The study evaluated the safety and biological effects of intranasal Foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS), a form of MS characterized by the gradual progression of neurological disability without active relapses.
Significant Reduction in Brain Inflammation
The randomized, double-blind, placebo-controlled study involved 48 participants across eight clinical centers in the United States.
Participants received either a placebo or one of two doses of intranasal Foralumab, 50 micrograms or 100 micrograms, during a 12-week treatment period.
According to the company, the 50-microgram dose demonstrated a statistically significant reduction in microglial activation compared with placebo (p=0.0168).
Microglia are specialized immune cells in the central nervous system that contribute to the brain’s immune response. Excessive or prolonged microglial activation is associated with neuroinflammation and may contribute to neurological damage in multiple sclerosis.
Researchers measured changes in microglial activation using positron emission tomography (PET), an advanced imaging technique that can help assess inflammatory activity in the brain.
However, the 100-microgram dose did not demonstrate a statistically significant reduction in the PET imaging endpoint compared with placebo.
Encouraging Safety and Tolerability Results
Another important finding was the treatment’s safety profile.
Both the 50-microgram and 100-microgram doses were generally well tolerated during the study.
All 48 participants completed the treatment period, with no reported deaths, treatment discontinuations due to adverse events, or serious adverse events attributed to the investigational drug.
The most commonly reported adverse events included headache, nasal congestion, runny nose, and falls.
These findings provide initial support for further investigation of the treatment’s safety and potential therapeutic applications.
Potential Improvements in MS-Related Fatigue
The study also investigated the effects of Foralumab on fatigue, one of the most common and challenging symptoms experienced by people living with multiple sclerosis.
Researchers used the Modified Fatigue Impact Scale (MFIS) to assess changes in fatigue-related symptoms.
Patients receiving the 50-microgram dose showed an average improvement of 6.17 points, while those receiving the 100-microgram dose experienced an average improvement of 7.18 points.
In comparison, the placebo group showed an average improvement of 3.12 points.
Although the changes from baseline were statistically significant within both treatment groups, the trial was not designed to establish definitive improvements in clinical symptoms.
No improvement was detected in the Expanded Disability Status Scale (EDSS) during the 12-week treatment period.
A New Direction in Multiple Sclerosis Research
Foralumab is a fully human monoclonal antibody targeting CD3, a protein involved in immune system regulation.
Unlike many conventional treatments, Foralumab is administered through the nasal route, an approach being investigated for its potential to influence immune responses associated with neurological inflammation.
The preliminary findings suggest that targeting inflammatory mechanisms may offer a promising strategy for developing treatments for progressive neurological disorders.
Nevertheless, further clinical studies involving larger patient populations and longer follow-up periods are necessary to determine whether the observed biological effects translate into meaningful and lasting clinical benefits.
Tiziana Life Sciences plans to complete its analysis of the trial results and discuss future development steps with the U.S. Food and Drug Administration.
While Foralumab remains an investigational treatment and is not yet approved for the treatment of multiple sclerosis, the findings represent an encouraging step in the ongoing search for new therapies for progressive forms of the disease.
Source: Tiziana Life Sciences – Phase 2a INFORM-MS Clinical Trial Results, November 2, 2026.
