Tiziana Life Sciences to Dose First Patient in Phase 2 Alzheimer's Trial

Core Viewpoint - Tiziana Life Sciences has initiated enrollment for a Phase 2 clinical trial of intranasal foralumab, targeting early Alzheimer's disease, with the first patient expected to be dosed next week [1][10]. Group 1: Clinical Trial Details - The Phase 2 trial will assess intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab, in early Alzheimer's patients [2][9]. - Baseline assessments including cognitive testing and TSPO-PET imaging have been completed for initial participants [2][11]. - Key endpoints of the trial will include measures of neuroinflammation, cognitive function, and changes in biomarkers related to amyloid and tau pathology [11]. Group 2: Scientific Insights - New TSPO-PET imaging evidence shows persistent microglial activation in an Alzheimer's patient treated with lecanemab, indicating ongoing neuroinflammation despite amyloid plaque reduction [3][4]. - Dr. Howard Weiner emphasized that clearing amyloid does not eliminate the brain's inflammatory response, suggesting that intranasal foralumab may effectively address this residual neuroinflammation [6][10]. Group 3: Mechanism of Action - Intranasal foralumab is designed to induce regulatory T cells to migrate to the brain, potentially calming activated microglia and reducing neuroinflammation [6][10]. - The therapy aims to provide an additive or synergistic benefit when used alongside anti-amyloid treatments by targeting both amyloid pathology and persistent microglial inflammation [9][10]. Group 4: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, with intranasal foralumab being the only fully human anti-CD3 monoclonal antibody in clinical development [13]. - The company aims to improve efficacy, safety, and tolerability of treatments compared to traditional intravenous delivery methods [13].