The US Food and Drug Administration (FDA) has granted approval for Tiziana Life Sciences’ investigational new drug (IND) to advance its Phase IIa study of intranasal foralumab intended to treat individuals with multiple system atrophy (MSA).
The open-label, six‑month study aims to assess the therapy’s impact on clinical outcomes, microglial activation, and safety in this patient group.
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Foralumabv is a fully human anti-CD3 monoclonal antibody delivered through a nasal spray in eight three-week dosing cycles. It is said to target T cell-mediated neuroinflammation.
MSA is said to be a quickly progressing neurodegenerative disorder, influencing autonomic and motor control functions, often resulting in minimised life expectancy and severe disability.
The ongoing expanded access programme for individuals with non-active secondary progressive multiple sclerosis (na-SPMS) has reported either improvement or disease stability within six months for all ten subjects dosed so far.
Foralumab is also under evaluation in a Phase IIa, double-blind, randomised, multi-centre, dose-ranging, placebo-controlled trial for na-SPMS.
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By GlobalDataThe Phase II trial for na-SPMS intranasal foralumab (NCT06292923) started subject screening in November 2023.
According to the company, intranasal foralumab is the sole fully human anti-CD3 monoclonal antibody undergoing clinical development.
The therapy has so far shown a promising safety profile and has elicited positive clinical outcomes in patients in trials.
Tiziana Life Sciences CEO Ivor Elrifi said: “Foralumab administered intranasally induces regulatory T cells and modulates T cell-driven inflammation. Its ability to reduce microglial activation presents a promising therapeutic strategy to slow neuronal damage in neuroinflammatory and degenerative diseases such as multiple sclerosis, Alzheimer’s disease, ALS, and MSA.
“This novel, non-systemic approach is designed to engage regulatory T cells, promoting immune tolerance while minimising systemic immune suppression.”
In April 2025, the company initiated dosing at the fourth clinical site of its Phase II trial for na-SPMS at the University of Massachusetts, US.
