Tiziana Life Sciences Ltd (NASDAQ:TLSA) said new biomarker data from an expanded-access program showed its experimental intranasal therapy reduced brain inflammation and was associated with neuroprotective changes in patients with a progressive form of multiple sclerosis.
The late-breaking findings were presented by investigators from Brigham and Women’s Hospital in a poster detailing results in 10 patients with non-active secondary progressive multiple sclerosis (na-SPMS) with progression independent of relapse activity (PIRA).
Tiziana’s lead candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system within the central nervous system.
In the program, patients received the experimental nasal treatment and were monitored closely over several months. Doctors performed a total of 14 matched sets of tests, which included specialized brain scans and analyses of spinal fluid samples taken at the start of treatment and periodically for up to six months.
The brain scans showed that patients had lower levels of inflammation in key areas of the brain after treatment. Specifically, activity from immune cells known as microglia, which become overactive in multiple sclerosis, declined over time. These reductions were seen by the three-month mark and continued at later follow-ups, and the changes were statistically meaningful.
Tests of the spinal fluid supported the scan results. Levels of proteins linked to inflammation decreased, while levels of proteins associated with protecting nerve cells increased. Researchers also found that higher inflammation seen on brain scans closely matched higher levels of inflammatory proteins in the spinal fluid. Conversely, as markers of brain inflammation fell, levels of protective proteins rose. Together, the findings suggest the treatment may be reducing harmful inflammation in the brain while promoting protective biological responses.
“These correlations demonstrate that [F-18]PBR06-PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response,” said Tarun Singhal, a neurologist at Brigham and Women’s Hospital and lead author of the poster.
Howard Weiner, chairman of Tiziana’s scientific advisory board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, said the integrated imaging and proteomic data strengthen the mechanistic rationale for the company’s ongoing mid-stage program. “Nasal foralumab continues to show a unique ability to dampen smoldering CNS inflammation while promoting neuroprotection. These integrated imaging and proteomic results strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.”
Tiziana is advancing intranasal foralumab in a randomized, double-blind, placebo-controlled Phase 2a trial, with top-line data expected in the first half of 2026. The company is also evaluating the therapy in other neuroinflammatory conditions, including multiple system atrophy, Alzheimer’s disease and amyotrophic lateral sclerosis.
Shares of Tiziana were up around 3.7% on Wednesday morning on the Nasdaq.