Tiziana Life Sciences announced positive preclinical results for their intranasal anti-CD3 monoclonal antibody, foralumab, in treating traumatic spinal cord injury (SCI). The treatment showed significant improvement in motor function in preclinical models after SCI, primarily by modulating microglial inflammation, a key driver of SCI pathogenesis. The company believes this nasal delivery method offers advantages in efficacy, safety, and tolerability compared to intravenous administration.

This development is potentially crucial for the SCI patient population, estimated at 300,000 in the US, with over 17,000 new cases annually. Current treatment options for SCI are limited, and often focus on managing symptoms rather than addressing the underlying inflammatory response. Foralumab’s potential to improve motor function by targeting this inflammation represents a possible shift towards disease-modifying therapies for SCI, offering new hope for patients.

Foralumab is currently in a Phase 2a trial for secondary progressive multiple sclerosis. The positive preclinical SCI data suggests potential expansion of foralumab’s clinical application into a new indication with high unmet medical need. This adds to the growing body of evidence supporting the use of intranasal anti-CD3 monoclonal antibodies as a therapeutic approach for neuroinflammatory and neurodegenerative diseases.

This positive preclinical data positions Tiziana to potentially move foralumab into clinical trials for SCI, significantly broadening its therapeutic pipeline. If successful in later-stage trials, foralumab could become a much-needed treatment option for SCI, offering improved motor function and quality of life for patients. This advancement also strengthens the potential of intranasal anti-CD3 therapy as a platform for treating a range of neurological conditions.

Source link: https://www.globenewswire.com/news-release/2025/01/23/3014558/0/en/Tiziana-Life-Sciences-Announces-Positive-Results-in-Treating-Spinal-Cord-Injury-With-Nasal-Anti-CD3.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.