Tiziana Life Sciences Ltd. dosed the first patient in its Phase 2, randomized, placebo‑controlled study of intranasal foralumab for early Alzheimer’s disease on December 17 2025, a day after the company announced the milestone on December 18 2025.
The trial evaluates foralumab both as monotherapy and in combination with the FDA‑approved anti‑amyloid agents lecanemab (Leqembi®) or donanemab. Primary endpoints include neuroinflammation measured by TSPO‑PET imaging, cognitive function scores, and changes in amyloid and tau biomarkers, with interim data slated for 2026.
Intranasal delivery bypasses the blood‑brain barrier and is designed to induce regulatory T cells that migrate to the brain and dampen microglial activation. This mechanism targets the neuroinflammation that persists after amyloid clearance, a gap that current anti‑amyloid therapies do not address. Prior studies in multiple sclerosis patients showed a reduction in microglial activation with the same formulation, supporting the translational potential to Alzheimer’s disease.
The first‑in‑human exposure marks a critical step for Tiziana’s intranasal platform and positions the company to expand its pipeline. If the combination with lecanemab or donanemab demonstrates additive or synergistic effects, it could differentiate Tiziana’s product from other anti‑amyloid drugs and accelerate regulatory approval pathways. The 2026 interim data will be a key indicator of safety, tolerability, and early efficacy signals that will shape the next phase of development.
CEO Ivor Elrifi said the dosing milestone “marks a pivotal moment in exploring a novel immunomodulatory approach to Alzheimer’s disease.” Chairman Gabriele Cerrone added that the company is “thrilled to have rapidly advanced from enrolment to first patient dosing” and that the trial “could redefine disease modification in Alzheimer’s disease.”
Tiziana’s intranasal platform has attracted significant investor interest, reflecting confidence in its potential to address a critical unmet need in neurodegenerative disease.
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