Tiziana Life Sciences (US:TLSA) Globenewswire·2026-01-20 16:15Core Viewpoint - Tiziana Life Sciences has announced the peer-reviewed publication of its study on intranasal foralumab for treating non-active secondary progressive multiple sclerosis (na-SPMS), marking a significant milestone in validating its therapeutic potential [1][2]. Study Publication - The publication titled "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis" details positive results from an open-label study, integrating TSPO-PET imaging, proteomics, and clinical assessments [2][4]. Study Highlights - The study represents a major milestone and external validation of intranasal foralumab's potential in treating secondary progressive MS, emphasizing its unique mechanism in addressing progression independent of relapse activity (PIRA) [4]. - Clinical stabilization and microglial PET findings support the biological effects of nasal foralumab in addressing PIRA in na-SPMS [4]. - The innovative intranasal delivery method modulates the immune system to suppress neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies [4]. Ongoing Trials - Tiziana is advancing intranasal foralumab in a randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in the first half of 2026 [5]. Patient Outcomes - In the open-label study, 14 patients with na-SPMS were dosed, showing stabilization of Expanded Disability Status Scale (EDSS) scores, with three out of four patients treated for 12 months demonstrating improvement [6]. - Fatigue improved in six out of ten patients, and no new T2 lesions appeared on MRI, indicating a favorable safety profile [6]. Unique Positioning - Foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel approach for treating neuroinflammatory and neurodegenerative diseases [8][9].