A Breath of Hope: Tiziana Nears Data on Nasal Spray for Progressive MS

BOSTON, MA – June 25, 2026 – In the relentless search for therapies that can alter the course of neurodegenerative disease, milestones often arrive not with a bang, but with the quiet, steady work of clinical science. Tiziana Life Sciences (Nasdaq: TLSA) announced such a milestone today: the final patient has been dosed in its Phase 2a INFORM-MS trial. The study evaluates a novel intranasal drug, foralumab, for a particularly challenging form of multiple sclerosis. With top-line data now expected in late 2026, the biotechnology world and a community of underserved patients are watching with bated breath.

This isn't just another drug trial. It represents a potential paradigm shift for treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS), a condition largely untouched by the last two decades of therapeutic advancements. The completion of dosing moves Tiziana one crucial step closer to learning whether its innovative approach—a monoclonal antibody delivered via a simple nasal spray—can succeed where so many others have failed.

The Silent Progression: A Treatment Desert in MS

Multiple sclerosis is a complex autoimmune disease where the body's immune system mistakenly attacks the protective myelin sheath covering nerve fibers. For many, the journey begins with relapsing-remitting MS (RRMS), characterized by flare-ups followed by periods of recovery. But for a majority of these individuals, the disease eventually transitions into a progressive phase where disability accumulates steadily, without the distinct relapses that define RRMS.

This is Secondary Progressive MS. When this progression occurs without new inflammatory lesions on an MRI, it’s classified as non-active SPMS. Here, the disease shifts from an inflammatory-driven process to a slow, insidious neurodegeneration. Patients experience a gradual worsening of symptoms like fatigue, mobility issues, and cognitive decline. It’s a devastating diagnosis, not only because of the functional loss but because the arsenal of modern disease-modifying therapies (DMTs) is largely ineffective. Most DMTs work by tamping down the inflammation that causes relapses, offering little benefit once the disease has entered this smoldering, neurodegenerative stage. This has created a vast and frustrating treatment desert for the na-SPMS population, whose care is often limited to managing symptoms rather than halting the underlying disease.

A New Route to the Brain: The Science of Intranasal Foralumab

This is the challenging landscape Tiziana aims to reshape with foralumab. The drug is the only fully human anti-CD3 monoclonal antibody in clinical development, but its true innovation lies in its delivery. Instead of a systemic intravenous infusion, foralumab is administered intranasally.

This route is a clever biological hack. The nasal cavity offers a direct pathway to the central nervous system, bypassing the formidable blood-brain barrier that blocks most large-molecule drugs from reaching their target. By targeting immune cells in the nasal passages, the therapy is designed to induce a specific type of immune cell called a regulatory T-cell (Treg). These Tregs are the immune system’s peacekeepers; their job is to suppress excessive inflammation. The hypothesis is that these nasally-induced Tregs can then migrate to the brain and calm the chronic, low-grade neuroinflammation driven by microglial cells—the brain's resident immune sentinels—that is believed to be a key driver of progression in na-SPMS.

Reflecting this mechanism, the INFORM-MS trial’s primary endpoint is not a traditional clinical measure but a biological one: the change in microglial activation as measured by positron emission tomography (PET) scans. This sophisticated imaging allows researchers to directly visualize the drug's effect on brain inflammation, providing an early and objective signal of biological activity before clinical improvements might become apparent.

“Intranasal foralumab represents a promising and innovative therapeutic strategy for patients with non-active secondary progressive MS,” said Tanuja Chitnis, M.D., the trial's Principal Investigator and a senior neurologist at the Mass General Brigham Neuroscience Institute. “We are encouraged by the smooth initiation of dosing across sites and look forward to evaluating its impact on microglial activation.”

Building on a Foundation of Hope

The confidence to launch this randomized, placebo-controlled trial was built on encouraging results from a smaller, open-label Expanded Access (EA) program. In that study, which has treated some patients for up to three years, foralumab was well-tolerated and showed promising signals of efficacy. Data from 14 patients revealed that a majority achieved stabilization or even improvement in their disability scores, with many reporting a clinically meaningful reduction in fatigue—one of the most pervasive and debilitating symptoms of MS.

Crucially, these clinical observations were backed by the same PET imaging being used in the larger Phase 2 trial, which showed a reduction in microglial inflammation. This alignment between biological mechanism and clinical benefit, even in a small, uncontrolled study, provided a strong rationale for moving forward. The INFORM-MS trial, which involves up to 48 patients across leading U.S. centers like Johns Hopkins and Yale, is designed to provide the definitive, high-quality evidence needed to confirm these early findings.

“We are thrilled to reach this important milestone in our Phase 2 program,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “Intranasal foralumab has the potential to modulate the immune system in a targeted manner with a favorable safety profile, offering new hope for patients with na-SPMS, a condition with limited treatment options.”

High Stakes and a Pivotal Readout

The completion of patient dosing sets the stage for a high-stakes data readout later this year. For Tiziana, positive results would serve as a powerful validation of its entire intranasal delivery platform, potentially opening doors for treating other neuroinflammatory conditions like Alzheimer's disease. For patients with na-SPMS, it would represent the first glimmer of hope for a therapy that could finally address the progressive nature of their disease.

The results are slated to be presented at the joint ACTRIMS and ECTRIMS meeting in October, the premier global conference for MS research. A positive reception there could galvanize the neurology community and accelerate the drug’s path toward regulatory review. While the competitive landscape for MS includes powerful new drug classes like BTK inhibitors, foralumab’s unique mechanism and non-invasive delivery route give it a distinct and compelling profile. As the final doses are administered and the last data points are collected, a community of patients, clinicians, and scientists waits to see if this breath of hope will become a new standard of care.