Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) has announced the successful dosing of the first patient with moderate Alzheimer's disease with intranasal foralumab at Brigham and Women's Hospital in Boston, Massachusetts. This marks a significant step in the clinical development program for Alzheimer's disease, addressing a critical unmet need in a condition affecting millions worldwide.
Targeting Neuroinflammation in Alzheimer's
Alzheimer's disease presents a formidable global health challenge, with limited effective treatment options. Tiziana's approach with foralumab focuses on reducing inflammation in the brain, a key underlying mechanism believed to drive disease progression. Unlike treatments targeting beta amyloid or tau protein, intranasal foralumab stimulates T regulatory cells, which cross the blood-brain barrier to reduce neuroinflammation of glial cells.
Dr. Howard Weiner, Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board, and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, emphasized the potential of this approach: "We are excited to initiate this study with Tiziana's innovative intranasal Foralumab in this first patient with moderate Alzheimer's disease. There are no approved drugs to treat this stage of Alzheimer's disease. Targeting neuroinflammation represents a promising approach in the pursuit of disease-modifying therapies."
NIH Grant and Broader Development Program
The study at Brigham and Women’s Hospital is part of Tiziana’s broader development program for Foralumab, which includes other inflammatory and autoimmune indications. In September 2024, the National Institutes of Health (NIH), National Institute on Aging awarded a $4 Million grant to Dr. Howard Weiner to study nasal anti-CD3 for the treatment of Alzheimer’s disease (AD). This grant supports key research over several years, advancing preclinical and clinical studies of intranasal anti-CD3 as a potential treatment.
Foralumab: A Novel Immunomodulatory Approach
Foralumab, a fully human anti-CD3 monoclonal antibody, stimulates T regulatory cells when administered intranasally. It is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Previous data from an open-label Expanded Access Program in 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) showed either improvement or stabilization of disease within 6 months.
Activated T cells play a crucial role in the inflammatory process. Foralumab binds to the T cell receptor, dampening inflammation by modulating T cell function and suppressing effector features in multiple immune cell subsets. This immunomodulatory effect has been observed in patients with COVID and multiple sclerosis, as well as in healthy subjects.
Tiziana’s CEO, Ivor Elrifi, stated, "Dosing the first patient with intranasal Foralumab marks a significant milestone for Tiziana and underscores our commitment to advancing novel therapies for Alzheimer's disease. We look forward to the continued progress of this study and also plan a study of Foralumab in patients with mild Alzheimer's disease. Foralumab has the potential to make a meaningful difference for patients and their families."
