Nasal Spray for MS Shows Promise in Halting Brain Inflammation

BOSTON, MA – February 25, 2026 – Biotechnology firm Tiziana Life Sciences has announced compelling new data suggesting its experimental nasal spray, foralumab, can directly quell inflammation in the brains of patients with a debilitating form of progressive multiple sclerosis. The findings, presented by researchers from Brigham and Women’s Hospital, provide the first direct evidence linking the therapy to reduced inflammation and the promotion of protective processes within the central nervous system.

The Silent Progression of Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disease where the body's own immune system mistakenly attacks the protective myelin sheath covering nerve fibers in the brain and spinal cord. While many are familiar with the relapsing-remitting form of MS (RRMS), characterized by distinct attacks followed by periods of recovery, the disease can evolve into a more insidious stage: non-active secondary progressive MS (na-SPMS).

For patients with na-SPMS, the disease's relentless march no longer involves the flare-ups and remissions seen in earlier stages. Instead, they experience a steady, gradual worsening of neurological function, a process known as progression independent of relapse activity (PIRA). This "silent progression" is a primary driver of long-term disability, leading to significant challenges with mobility, coordination, cognition, and fatigue.

The underlying cause of this progression is believed to be smoldering, chronic inflammation within the central nervous system, driven by immune cells called microglia. Unlike the acute inflammation of relapses, this low-level, persistent activity slowly damages nerve cells, leading to irreversible neurodegeneration. This creates a significant therapeutic challenge, as many existing MS drugs are designed to target the acute inflammatory attacks of RRMS and have limited efficacy in halting this progressive phase. Consequently, a profound unmet need exists for treatments that can specifically address the neurodegenerative mechanisms of na-SPMS.

Connecting the Dots: Biomarkers Validate Brain Repair

The new data on foralumab, presented in a late-breaking poster, offers a potential breakthrough in this challenging area. The results come from an open-label study involving 10 patients with na-SPMS and PIRA who were treated with the nasal spray for up to six months. Researchers used a powerful combination of advanced imaging and fluid analysis to track the drug's biological effects.

Using a specialized PET scan with the tracer [F-18]PBR06, investigators could visualize and measure the activation of microglia—the key immune cells driving chronic inflammation in the brain. The results were significant: patients treated with nasal foralumab showed a marked reduction in microglial activation in both white matter and across the global brain. This provides a direct, visual confirmation that the therapy is calming the smoldering inflammation at the heart of the disease.

Crucially, these imaging findings were corroborated by analyzing the patients' cerebrospinal fluid (CSF), the fluid that bathes the brain and spinal cord. CSF analysis provides a direct window into the biochemical environment of the central nervous system. The study revealed a two-pronged effect:

• Downregulation of Inflammation: Key inflammatory proteins, such as IFNAR1 (part of the interferon pathway) and LY86 (part of the NF-κB pathway), were significantly reduced.
• Upregulation of Neuroprotection: Proteins associated with neural repair and protection, like MEG10, were found in higher concentrations.

“This late-breaking poster provides the first direct link between reduced microglial PET signal and favorable CSF proteomic shifts during nasal foralumab treatment in na-SPMS with PIRA,” said Dr. Tarun Singhal, the study's lead author and a neurologist at Brigham and Women’s Hospital. “The correlations demonstrate that [F-18]PBR06-PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response.”

The data showed a strong statistical correlation, with r values up to 0.896, linking higher levels of inflammation on PET scans to higher levels of inflammatory proteins in the CSF. Conversely, negative correlations (r values up to -0.931) were found between the PET signal and neuroprotective proteins. This tight linkage between imaging and molecular data provides powerful, objective evidence of foralumab's mechanism of action. The changes occurred alongside clinical stabilization or improvement in the patients, with no serious side effects reported.

A Novel Route for a Targeted Attack

What sets foralumab apart is not just its target but its delivery method. It is a fully human monoclonal antibody that targets CD3, a protein found on the surface of T-cells, which are key orchestrators of the immune response. By modulating these T-cells, the therapy aims to induce tolerance and reduce inflammation.

However, instead of being delivered via intravenous infusion, which causes widespread systemic immunosuppression, foralumab is administered as a nasal spray. This innovative intranasal route is designed to deliver the drug directly to the lymphatic system in the head and neck, allowing it to modulate the immune system locally before it enters the central nervous system. The goal is to suppress the specific neuroinflammatory processes driving MS without compromising the body's entire immune defense system, a common side effect of many current treatments.

Dr. Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board and a key figure at Brigham and Women’s Hospital, commented on this unique mechanism. “Nasal foralumab continues to show a unique ability to dampen smoldering CNS inflammation while promoting neuroprotection," he stated. "These integrated imaging and proteomic results strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.”

This targeted, non-systemic approach could represent a paradigm shift in treating neuroinflammatory diseases, potentially offering a better safety profile and improved quality of life for patients who must take medication long-term.

The Path Forward for Foralumab

While the biomarker data from this small, open-label study is highly encouraging, the ultimate test for foralumab will be in larger, controlled clinical trials. Tiziana Life Sciences is currently conducting a randomized, double-blind, placebo-controlled Phase 2a trial to rigorously evaluate the drug's efficacy and safety in a larger group of na-SPMS patients. The results from this pivotal study are highly anticipated, with top-line data expected in the first half of 2026.

Success in this trial could position foralumab as a first-in-class therapy for a patient population with no currently approved treatments and a desperate need for options that can slow or halt their disability progression. Given the lack of competition in the non-active SPMS space, a positive outcome would represent a significant commercial opportunity for the company and, more importantly, a beacon of hope for thousands of patients. Tiziana is also exploring the potential of its intranasal platform for other neurodegenerative conditions driven by inflammation, including Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and multiple system atrophy (MSA), suggesting a broad future for this innovative therapeutic approach.