Tiziana Life Sciences Ltd. (TLSA) announced the submission of its Investigational New Drug or IND application to the FDA for a Phase 2 clinical trial of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating Amyotrophic Lateral Sclerosis or ALS.
The submission follows the receipt of a grant from the ALS Association, supporting the company's commitment to advancing new treatment approaches for ALS.
Tiziana plans to initiate a 20-patient trial evaluating the safety and early-stage efficacy of intranasal foralumab upon FDA clearance of the IND application.
The trial will assess the safety profile and disease improvement in ALS patients, with the primary goal to evaluate early-stage parameters of disease progression.
Intranasal foralumab is expected to offer a novel immunomodulatory approach to treat ALS, a disease with limited treatment options and a rapid progression.
Tiziana's lead candidate, intranasal foralumab, is currently being studied in other neurodegenerative diseases, including Multiple Sclerosis and Alzheimer's disease.
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