Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Tuesday that a peer-reviewed study of its experimental intranasal therapy for secondary progressive multiple sclerosis (SPMS) has been published in the journal Neurology Neuroimmunology & Neuroinflammation.
The study, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” evaluated intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in 10 patients with non-active SPMS (na-SPMS) who continued to progress despite prior B-cell therapies.
Key findings included stabilization of disability scores in all patients, improvements in fatigue for six of 10 participants, and no new lesions on MRI scans. Advanced imaging and immune profiling revealed significant reductions in microglial activation and increases in regulatory T cells, indicating modulation of central nervous system inflammation. No serious treatment-related adverse events were reported.
“This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab's therapeutic potential in secondary progressive MS,” said Dr Tanuja Chitnis, principal investigator at Brigham and Women’s Hospital.
“The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets CNS inflammation through mucosal tolerance, offering hope for patients with limited options.”
Dr Howard Weiner, chairman of Tiziana’s scientific advisory board, added that the biomarker discoveries support the therapy’s biological effects in addressing progression independent of relapse activity (PIRA) in na-SPMS.
CEO Ivor Elrifi said the publication reinforces confidence in the therapy as a potential “paradigm-shifting” treatment for progressive MS.
Tiziana said it is currently conducting a randomized, double-blind, placebo-controlled Phase 2 trial, with top-line data expected in the first half of 2026.