Tiziana Life Sciences has announced that the last patient has begun dosing in its phase 2 randomised, 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 US Food and Drug Administration (FDA)-approved anti-amyloid therapies lecanemab (leqembi) or donanemab. The trial builds on evidence of persistent neuroinflammation (microglial activation) in Alzheimer’s Disease (AD) 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.

Ivor Elrifi, Chief Executive Officer, Tiziana Life Sciences, said, “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. We look forward to generating data that could help establish immunomodulation as a complementary pillar in the treatment of early Alzheimer’s Disease.”

The phase 2 study is a randomised, placebo-controlled trial in patients with early/mild Alzheimer’s Disease (AD). It evaluates intranasal foralumab as monotherapy and in combination with lecanemab or donanemab. Primary focus areas include safety/tolerability, reduction in microglial activation measured by TSPO-PET, cognitive outcomes, and changes in amyloid and tau biomarkers.

Dr. Howard L Weiner, Chairman, Scientific Advisory Board, Tiziana, and Co-Director of the Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, commented, “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. 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. We look forward to seeing the results from this placebo-controlled trial.”

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a phase 2a, randomised, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923), as well as additional phase 2 trials in AD and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.