Tiziana Life Sciences doses first patient in Phase 2 Alzheimer’s trial

Tiziana Life Sciences (TLSA) announces that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease. This milestone follows the Company’s December 12, announcement that enrolment had begun and the first patient was expected to be dosed imminently. The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab, in patients with early AD. The trial is supported by TSPO-PET imaging data demonstrating persistent and widespread microglial activation-a hallmark of neuroinflammation-in Alzheimer’s patients, even after amyloid plaque reduction with lecanemab. This evidence underscores the need for therapies targeting residual neuroinflammation, which intranasal foralumab is designed to address by modulating immune responses and calming activated microglia.