Pharma Focus America

Tiziana Life Sciences Begins Treating First Patient with Moderate Alzheimer’s Disease Using Foralumab

Thursday, June 27, 2024

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) has announced that the U.S. Food and Drug Administration (FDA) has approved the use of intranasal foralumab under an Expanded Access (EA) Investigational New Drug (IND) for its first patient with moderate Alzheimer’s disease. This approval allows patients to access investigational treatments when no satisfactory alternatives exist outside of clinical trials.

Dr. Howard L. Weiner, Principal Investigator and Chairman of Tiziana’s Scientific Advisory Board, expressed excitement about starting treatment with nasal foralumab as early as July for this initial patient. He emphasized the critical need for effective treatments, especially in cases where current therapies, including recently approved anti-amyloid drugs, are inadequate. Dr. Weiner highlighted the potential of nasal foralumab to reduce cognitive decline by targeting microglial inflammation, a significant factor in Alzheimer’s disease progression, based on its success in reducing inflammation in advanced progressive MS.

Tiziana emphasized the importance of this FDA clearance, which expands their research beyond the previously approved Phase 2a study for early symptomatic Alzheimer’s disease. He expressed optimism about foralumab’s potential as a transformative treatment for Alzheimer’s disease by addressing underlying neuroinflammation caused by toxic protein accumulation in the brain.

Foralumab, a fully human anti-CD3 monoclonal antibody, targets activated T cells to modulate inflammation and suppress effector functions across multiple immune cell subsets. This mechanism has shown promise in various conditions, including COVID-19 and multiple sclerosis, as well as in healthy subjects. Tiziana is actively screening patients for its Phase 2 trial (NCT06292923) investigating intranasal foralumab in non-active secondary progressive MS, demonstrating its innovative approach to treating neuroinflammatory and neurodegenerative diseases.



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