Tiziana doses last patient in Phase 2 Alzheimer's trial of intranasal foralumab

Tiziana Life Sciences Ltd (Nasdaq: TLSA) said on October 16, 2026 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.¹ The company said topline data are anticipated to be announced in the first quarter of 2027.¹

With enrollment and dosing now complete across all participants, the trial is examining foralumab both alone and alongside the FDA-approved anti-amyloid drugs lecanemab (marketed as Leqembi) and donanemab. The design is based on evidence that neuroinflammation, including microglial activation, persists in Alzheimer's patients even among those already treated with anti-amyloid agents, as detected by TSPO-PET imaging.¹ The study's key endpoints cover changes in neuroinflammation measured by TSPO-PET, cognitive function, and biomarkers tied to amyloid and tau pathology.¹

Foralumab is described as a fully human anti-CD3 monoclonal antibody that has been shown to stimulate T regulatory cells when administered intranasally.¹ The company noted that 14 patients with non-active secondary progressive multiple sclerosis have been dosed under an open-label Expanded Access Program (NCT06802328), with improvement or stability of disease observed in all patients within six months.¹

Separately, intranasal foralumab is also being evaluated in a dose-ranging Phase 2a trial for non-active secondary progressive multiple sclerosis (NCT06292923), along with additional Phase 2 studies in Alzheimer's disease and multiple system atrophy (MSA).¹ Tiziana said intranasal foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development.¹