The poster, titled "A Phase 2a Study of Intranasal Foralumab in Multiple System Atrophy," will highlight the design and rationale of the ongoing TILS-025 trial (NCT06868628), the first clinical investigation of intranasal anti-CD3 therapy in MSA.

Multiple System Atrophy is a rapidly progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar impairment, with no approved disease-modifying therapies. Neuroinflammation and microglial activation are recognized as key drivers of disease progression. Foralumab, delivered intranasally, has previously shown a reduction of neuroinflammation in clinical studies for multiple sclerosis and Alzheimer's disease. The TILS-025 study evaluates its potential to attenuate microglial activation in MSA.

This Phase 2a, open-label trial is enrolling up to 10 subjects with clinically established or clinically probable MSA (per 2022 MDS criteria), ages 30–85, in collaboration with the Mass General Brigham MyTrial-MSA and Harvard Biomarkers Study 2.0 programs. Participants receive intranasal foralumab (50 μg per dose) for 6 months, with pre-treatment observational data collected where available. Primary endpoints include changes in microglial activation measured by [F-18]PBR06 TSPO PET imaging and changes in MDS-UMSARS scores. Secondary endpoints encompass regional brain atrophy on volumetric MRI, autonomic function, quality-of-life measures, and immune biomarkers in blood and CSF.

"We are thrilled that our Phase 2a study of intranasal foralumab in Multiple System Atrophy has been selected as a late-breaking poster at the 7th World Parkinson Congress," said Ivor Elrifi, CEO of Tiziana Life Sciences. "This acceptance underscores the growing interest in foralumab's novel intranasal approach to modulating neuroinflammation. MSA is a devastating disease with high unmet need, and we believe foralumab's ability to target microglial activation could represent a meaningful step forward for patients. We look forward to sharing updates from this important trial with the global Parkinson's and MSA community in Phoenix."