Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Wednesday it has dosed the first patient in a Phase 2 clinical trial testing its intranasal drug candidate foralumab in patients with early Alzheimer’s disease.
The randomized, placebo-controlled study will evaluate foralumab as a standalone treatment and in combination with FDA-approved anti-amyloid drugs lecanemab (Leqembi) or donanemab in people with early or mild Alzheimer’s, the company said.
The trial follows imaging data showing persistent neuroinflammation in Alzheimer’s patients even after amyloid plaques are reduced with existing therapies, highlighting a potential need for treatments that address inflammation in the brain.
“Dosing the first patient marks a pivotal moment in exploring a novel immunomodulatory approach to Alzheimer’s disease,” said Gabriele Cerrone, chairman of Tiziana Life Sciences, adding that prior imaging data in multiple sclerosis showed intranasal foralumab reduced microglial activation.
CEO Ivor Elrifi said the move from enrolment to first dosing reflects the urgency for treatment strategies that go beyond amyloid clearance to target chronic neuroinflammation.
The Phase 2 study will assess safety, tolerability and potential efficacy, with primary endpoints including neuroinflammation measured by TSPO-PET imaging, cognitive outcomes and changes in amyloid and tau biomarkers. Interim data are expected in 2026.
Foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate immune responses when administered intranasally.