Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that the US Food & Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA).
The Phase 2a study is a six-month, open-label clinical trial designed to evaluate the effects of intranasal foralumab on microglial activation, clinical outcomes, and safety in MSA patients.
Foralumab is a fully human anti-CD3 monoclonal antibody that targets T-cell mediated neuroinflammation and is administered via nasal spray in eight three-week dosing cycles.
MSA is a rare, rapidly progressive neurodegenerative disorder affecting autonomic and motor functions, with no FDA-approved therapies.
The disease has an incidence of 0.6 per 100,000 person-years in the US, rising to 3 per 100,000 among those aged 50 and older.
MSA leads to severe disability and shortened life expectancy, with median survival between six and nine years.
Disease progression is assessed using the unified MSA rating scale (UMSARS), which measures daily living activities, autonomic and motor impairment, and overall disability. Neuroinflammation and microglial activation are implicated as key drivers in MSA pathogenesis, Tiziana highlighted.
“Neuroinflammation plays a significant role in MSA’s rapid progression. Intranasal foralumab offers a novel therapeutic pathway by targeting T-cell mediated immune activation in the brain,” Dr Vikram Khurana, principal investigator for the MSA trial, said.
“We aim to observe whether this therapy can meaningfully impact microglial activity and important clinical outcomes over six months in patients with MSA.”
Ivor Elrifi, Tiziana CEO, added that foralumab when 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,” Elrifi said. “This novel, non-systemic approach is designed to engage regulatory T cells, promoting immune tolerance while minimizing systemic immune suppression.”
Shares of Tiziana climbed nearly 13% at Monday’s open.