Tiziana Life Sciences has announced the acceptance of a late-breaking poster detailing its Phase 2a study of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of Multiple System Atrophy (MSA). This presentation will occur at the 7th World Parkinson Congress in May 2026, showcasing the ongoing TILS-025 trial (NCT06868628), which is the first clinical investigation of intranasal anti-CD3 therapy in MSA. Given the lack of approved disease-modifying therapies for MSA, this study is particularly significant, as neuroinflammation and microglial activation are known to drive disease progression.

The trial aims to assess foralumab’s ability to attenuate microglial activation in MSA patients, leveraging its previously demonstrated efficacy in reducing neuroinflammation in conditions like multiple sclerosis and Alzheimer’s disease. The open-label study will enroll up to 10 subjects aged 30-85, focusing on primary endpoints such as changes in microglial activation via [F-18]PBR06 TSPO PET imaging and clinical assessments using MDS-UMSARS scores. Secondary endpoints include evaluations of brain atrophy, autonomic function, quality of life, and immune biomarkers, providing a comprehensive view of foralumab’s therapeutic impact.

The implications of this research extend beyond MSA, as it may redefine the approach to neuroinflammatory and neurodegenerative diseases by demonstrating the potential of intranasal delivery for immunomodulation. Tiziana’s novel delivery method could enhance efficacy and safety compared to traditional intravenous routes, potentially accelerating drug development timelines and paving the way for broader applications of immunotherapy in aging-related disorders.

Source: globenewswire.com