Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has enrolled and dosed the first participant in its Phase 2a clinical trial evaluating intranasal foralumab in patients with Multiple System Atrophy (MSA).
The trial is being conducted at Brigham and Women’s Hospital in Boston.
MSA is a rare and rapidly progressive neurodegenerative disorder that impairs movement, balance, and autonomic functions.
The US Food and Drug Administration has classified it as an orphan disease, with an estimated 15,000 to 50,000 people affected nationwide. There are currently no FDA-approved treatments that modify its progression.
Tiziana’s six-month, open-label study will administer intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, over eight dosing cycles.
The therapy is designed to reduce neuroinflammation by activating regulatory T cells through a non-systemic delivery method.
The primary aim of the study is to assess whether this approach can slow disease progression and improve patient quality of life.
“Our mission is to bring forward therapies that tackle the root causes of neurodegeneration, not just the symptoms. Dosing our first patient in this MSA study marks an important milestone in that mission,” Tiziana CEO Ivor Elrifi said in a statement.
“We are hopeful that foralumab’s unique mechanism, modulating immune response through the nasal pathway, can open new doors in treating diseases where inflammation and degeneration are intertwined.”
Dr Vikram Khurana, principal investigator of the MSA trial, highlighted the lack of treatment options available for MSA patients.
“This trial represents an important opportunity to explore a treatment aimed directly at the immune processes that may drive the disease,” Dr Khurana said.
“The intranasal route allows us to reach the brain’s immune environment in a way that is both targeted and potentially more tolerable for patients.”