Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer's Clinical Trial

Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].