Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy
August 14, 2025 – Clinical Trials – clinical trials
BOSTON, Aug. 14, 2025 — Tiziana Life Sciences, Ltd (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients living with Multiple System Atrophy (MSA) at Brigham and Women’s Hospital in Boston, Massachusetts.
MSA is a rare, rapidly progressive neurodegenerative disorder affecting the body’s movement, balance, and autonomic functions. Classified as an orphan disease by the FDA, MSA affects an estimated 15,000–50,000 people in the United States. There are no FDA-approved treatments that alter its course, creating a critical need for new therapeutic strategies.
The six-month open-label study (ClinicalTrials.gov Identifier: NCT06868628) will assess the potential of foralumab to reduce harmful neuroinflammation by engaging the body’s regulatory T cells through a novel, non-systemic delivery approach. Participants will receive treatment over eight dosing cycles, with the goal of determining whether this approach can slow disease progression and improve quality of life.
“We are excited to begin dosing nasal foralumab in MSA patients,” Said Dr. Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair in Neurology, and Division Chief of Movement Disorders and Director of the MSA Center of Excellence at Brigham and Women’s Hospital and Principal Investigator of the MSA trial, commented: “Every patient I meet with MSA faces a reality of mounting symptoms and few options. This trial represents an important opportunity to explore a treatment aimed directly at the immune processes that may drive the disease. 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.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, added: “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. 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.” The trial builds on Tiziana’s broader research into foralumab in neuroinflammatory and neurodegenerative diseases, where early studies have suggested benefits in stabilizing or improving function in conditions such as multiple sclerosis.
