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Tiziana Life Sciences Files New Drug Application for ALS Drug Candidate
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Tiziana Life Sciences Files New Drug Application for ALS Drug Candidate
Mar 4, 2025 6:25 AM

09:02 AM EST, 03/04/2025 (MT Newswires) -- 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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