Tiziana Doses Last Patient in Phase 2 Trial of Intranasal Foralumab for Mild Alzheimer’s Disease
Key Highlights
- ➤Last patient began dosing in Phase 2 mild Alzheimer’s trial of intranasal foralumab
- ➤Topline Alzheimer’s trial data anticipated in Q1 2027
- ➤Trial evaluates foralumab alone and alongside lecanemab or donanemab
- ➤Endpoints include TSPO-PET neuroinflammation, cognition, and amyloid and tau biomarkers
Expert Statements
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“Dosing the last patient in this important Phase 2 trial is a significant achievement for our team, clinical sites, and the patients participating in the study”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences
“We look forward to generating data that could help establish immunomodulation as a complementary pillar in the treatment of early Alzheimer’s disease.”
Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital
“Completing dosing initiation for the final patient marks an important step in testing whether inducing regulatory T cells with intranasal foralumab can calm activated microglia and potentially slow disease progression in mild Alzheimer’s”
Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital
“Our prior work, including TSPO-PET findings in multiple sclerosis and the moderate Alzheimer’s expanded-access experience, supports the biological rationale that addressing chronic brain inflammation alone or alongside anti-amyloid therapy, may offer meaningful benefit.”
Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital
“We look forward to seeing the results from this placebo-controlled trial.”
BOSTON, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“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 last patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early/mild Alzheimer’s disease (AD). Topline data are anticipated to be announced in Q1 2027.
This milestone completes enrollment and initiates dosing for all participants in the study, which is assessing the safety, tolerability, and potential efficacy of intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies lecanemab (Leqembi®) or donanemab. The trial builds on evidence of persistent neuroinflammation (microglial activation) in Alzheimer’s patients, including those treated with anti-amyloid agents, as measured by TSPO-PET imaging. Key endpoints include changes in neuroinflammation via TSPO-PET imaging, cognitive function, and fluid biomarkers related to amyloid and tau pathology.
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