Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRA

Core Viewpoint - Tiziana Life Sciences announces positive biomarker data for its lead candidate, intranasal foralumab, indicating its potential to downregulate inflammation and promote neuroprotection in patients with non-active secondary progressive multiple sclerosis (na-SPMS) [1][4]. 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]. - The company’s lead candidate, foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in previous studies [8][7]. Product Development - Foralumab is being evaluated in an ongoing randomized, double-blind, placebo-controlled Phase 2a trial for na-SPMS, with top-line data expected in the first half of 2026 [4][6]. - The therapy aims to modulate the immune system to suppress neuroinflammation without broad systemic immunosuppression, distinguishing it from existing multiple sclerosis treatments [4][8]. Clinical Findings - The late-breaking poster presented results from 10 patients treated with nasal foralumab, showing a reduction in microglial activation and favorable shifts in cerebrospinal fluid (CSF) proteomics [3][5]. - Key findings include significant correlations between reduced microglial PET signals and changes in CSF proteomic biomarkers, indicating a biological link to the inflammatory processes in SPMS [4][5]. Future Directions - Tiziana is also exploring the use of foralumab in other neuroinflammatory conditions such as multiple system atrophy (MSA), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS) [4][8].