Tiziana Life Sciences (TLSA) Newsfilter·2025-02-11 14:15Core Viewpoint - Tiziana Life Sciences is advancing its investigational drug, intranasal foralumab, for moderate Alzheimer's disease, which currently lacks effective treatment options, as highlighted in a recent news segment featuring a patient from the company's expanded access program [1][2]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [8][9]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [9]. Drug Mechanism and Efficacy - Foralumab targets immune system dysregulation associated with Alzheimer's disease, potentially slowing disease progression and improving cognitive function by modulating inflammation linked to neurodegeneration [3][5]. - The drug has shown efficacy in reducing microglial activation and inducing T regulatory cells, which help modulate neuroinflammation, validated in animal models and patients with secondary progressive multiple sclerosis [5][7]. Expanded Access Program - The expanded access program allows patients without access to clinical trials to receive intranasal foralumab as part of a compassionate use initiative, with initial results showing improvement or stability in disease for all 10 patients dosed [6]. Clinical Trials - Tiziana is conducting a Phase 2a, randomized, double-blind, placebo-controlled trial for intranasal foralumab in patients with non-active secondary progressive multiple sclerosis, which began screening patients in November 2023 [7][6].