(RTTNews) - Wednesday, Tiziana Life Sciences (TLSA) said it submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA). Foralumab is a fully human anti-CD3 monoclonal antibody being developed as an intranasal immunomodulatory therapy for neuroinflammatory and neurodegenerative diseases. Tiziana is evaluating intranasal foralumab in a six-month Phase 2a open-label study in patients with MSA. The study is assessing microglial activation through PET imaging, clinical outcomes and safety. If granted, the Orphan Drug Designation could provide benefits including potential market exclusivity, tax credits for qualified clinical testing and waiver of certain FDA application fees.
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