(4)
🧠 1. A Platform With Real-World Clinical Impact (4)(5)(6)(7)
Tiziana’s lead program centers on intranasal foralumab, a fully human anti-CD3 monoclonal antibody delivered through the nose—a non-invasive route designed
to induce immune regulation directly at the brain-immune interface. This isn't a theoretical mechanism: it’s been tested in real patients, with results that are turning heads in the neurology space.
In a recent Expanded Access study focused on non-active Secondary Progressive Multiple Sclerosis (SPMS)—a condition with no currently approved treatments—foralumab showed zero disability progression
across all participants over 6 months (100% EDSS stabilization). Even more encouraging, over half the participants reported fatigue improvement, a notoriously difficult symptom to address. PET imaging showed clear biological effects: significant reduction in microglial activation, the inflammatory footprint in the brain.
💡 No serious adverse events were reported.
A larger, double-blind Phase
2 trial is now underway, with topline data expected by the end of 2025. But Tiziana isn’t stopping there—Alzheimer’s and ALS trials using the same platform are already moving forward. The bet here is not just one condition, but a multi-disease strategy across neuroinflammation.
🏛️ 2. Backed by the Best — Clinical Sites and Scientific Allies (4)(5)(6)(7)
The strength of Tiziana’s relationships says a lot about the science. Their SPMS trial is running at world-class institutions like Brigham & Women’s Hospital, Yale, Johns Hopkins, and UMass—centers that don’t partner lightly. These collaborations lend clinical credibility and executional firepower to the program.
The reach is expanding.
The ALS Association is helping fund an upcoming ALS trial of foralumab—external capital and validation in one stroke. The company has also begun dosing patients with Alzheimer’s under an Expanded Access protocol, while a $4 million NIH grant supports broader research into foralumab in neurodegeneration.
This isn’t science in a silo—it’s a platform that’s capturing the attention of academia, regulators, and advocacy groups
alike.
🧪 3. Phase 2 Trials Advancing With Speed—and Backed by the FDA (4)(5)(6)(7)
Tiziana’s programs aren’t just progressing—they’re accelerating with strong regulatory momentum and clinical clarity.
- In non-active SPMS, the ongoing Phase 2a trial is fully enrolled and scheduled for
a topline data readout by the end of 2025. This follows compelling Expanded Access data showing 100% EDSS stabilization and marked reduction in neuroinflammation. The current trial includes biomarker-driven endpoints and is being run at elite medical centers, raising the stakes—and the credibility.
- Tiziana has also secured the green light for a Phase 2 Alzheimer’s study, expected to begin in 1H
2025. Supported by a $4 million NIH grant, this trial will evaluate foralumab in early symptomatic Alzheimer’s patients, measuring microglial activation and cognitive markers.
- And for ALS, the company filed an IND in March 2025 to launch another Phase 2 trial. Funded in part by the ALS Association, the study will assess foralumab’s role in slowing disease biology over a six-month dosing
window.
Most notably, foralumab received Fast Track designation from the FDA for SPMS, providing a path to faster review and increased regulatory dialogue. It’s a clear signal: agencies are aligned with the science, and doors are opening faster than usual.
