Tiziana's Intranasal Foralumab Shows Promise: Peer-Reviewed Clinical Data Validates Progression Control Strategy

Tiziana Life Sciences (NASDAQ: TLSA) has achieved a significant milestone with the peer-reviewed publication of its clinical research on intranasal foralumab for progressive multiple sclerosis. The study, now appearing in the prestigious journal Neurology Neuroimmunology & Neuroinflammation, provides critical validation for an emerging therapeutic approach targeting patients who experience continued neurological decline despite prior treatments.

Breaking Through Treatment Resistance: Intranasal Innovation for Advanced MS

Non-active secondary progressive multiple sclerosis (na-SPMS) represents one of the most challenging phases of MS, characterized by steady neurological deterioration without the inflammatory relapses seen in earlier disease stages. Patients at this stage face a significant clinical dilemma: existing B-cell targeted therapies often fail to halt disease progression, leaving physicians and patients with limited options. The intranasal foralumab approach emerged as a potential solution designed to address this substantial treatment gap.

What the Clinical Data Reveals: Study Results and Safety Profile

The published research evaluated intranasal delivery of foralumab—a fully human anti-CD3 monoclonal antibody—in 10 na-SPMS patients who had continued declining despite receiving prior B-cell-directed immunotherapies. The clinical trial demonstrated several encouraging outcomes: patients showed measurable improvements in clinical symptoms, biomarker analysis revealed shifts consistent with reduced inflammation, and critically, the treatment maintained a favorable safety profile with no major adverse events reported. The research findings confirm data originally disclosed by the company in May 2025, now undergoing rigorous peer review validation.

Why Intranasal Delivery Represents a Paradigm Shift

The intranasal route distinguishes Tiziana’s approach from conventional systemic immunosuppressive therapies. By delivering foralumab through mucosal pathways, the treatment engages the immune system more selectively and potentially with reduced systemic side effects compared to traditional intravenous or subcutaneous approaches. This delivery mechanism has been positioned as a key competitive advantage in autoimmune disease treatment, potentially offering both efficacy and tolerability benefits that address unmet needs in the MS patient population.

Advancing to the Next Phase: Expanding Clinical Evidence

With peer-reviewed validation now established, Tiziana is progressing intranasal foralumab through a randomized, double-blind, placebo-controlled Phase 2 clinical trial in na-SPMS patients. The company has indicated that top-line efficacy and safety data from this expanded trial are expected during the first half of 2026. Beyond the current MS program, Tiziana has signaled its intention to explore the intranasal platform’s potential applications across broader neuroinflammatory and autoimmune conditions.

Market Context and Investor Considerations

TLSA shares have experienced notable volatility, trading within a $0.63 to $2.60 range over the past year. Recent trading activity showed the stock closing a previous session at $1.58 (down 5.95%) before rising to $1.69 in after-hours trading (up 6.96%). The publication of this peer-reviewed data represents an important validation step that could influence market perception of the company’s therapeutic pipeline and the intranasal foralumab program’s viability.