Tiziana Life Sciences (TLSA) said Tuesday it filed an investigational new drug application for foralumab, a potential treatment for amyotrophic lateral sclerosis, with the US Food and Drug Administration.
The application is supported by a grant from the ALS Association as part of the Hoffman ALS Clinical Trial Awards Program, the company said.
The company's development programs for Foralumab, a nasal anti-CD3 monoclonal antibody, are also being focused on multiple sclerosis and Alzheimer's disease.
Upon getting the agency's clearance, Tiziana said it plans to begin a 20-patient clinical trial of two doses of intranasal foralumab aimed at evaluating the safety and early-stage parameters of disease improvement in amyotrophic lateral sclerosis.
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