Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has begun enrolling participants in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in early Alzheimer’s disease, with the first patient expected to be dosed next week.
The trial will study foralumab, a fully human anti-CD3 monoclonal antibody, as both a standalone therapy and in combination with the FDA-approved anti-amyloid drugs lecanemab or donanemab.
According to the company, baseline assessments, including cognitive testing, fluid biomarkers, and TSPO-PET imaging, have been completed for the first screened participants.
Tiziana said the launch of the study is supported by new TSPO-PET imaging from an Alzheimer’s patient treated with lecanemab, marketed as Leqembi, showing persistent microglial activation despite amyloid plaque reduction. The company said the finding indicates neuroinflammation remained detectable.
Dr Howard Weiner, chairman of Tiziana’s Scientific Advisory Board, highlighted the significant of this new information. “This PET finding is a critical insight: clearing amyloid does not turn off the brain’s inflammatory response,” Dr Weiner said.
“We believe intranasal foralumab directly addresses this residual neuroinflammation by inducing regulatory T cells to migrate to the brain and calm activated microglia — a mechanism we have already shown reduces microglial activation in secondary progressive multiple sclerosis.”
The Phase 2 study will evaluate safety, tolerability, and efficacy, with key endpoints including TSPO-PET measures of neuroinflammation, cognitive outcomes, and amyloid- and tau-related biomarkers.
The trial is designed to measure whether foralumab reduces microglial activation and slows cognitive decline as a monotherapy, and whether combining it with lecanemab or donanemab yields added benefit.
“With enrolment now underway and baseline neuroimaging and biomarkers secured, we are on the verge of testing a fundamentally new approach to Alzheimer’s — one that treats the chronic brain inflammation that is associated with ongoing neurodegeneration,” Tiziana CEO Ivor Elrifi said.
“The PET evidence of inflammation in AD with or without anti-amyloid treatment provides a clear biological rationale for this innovative strategy.”