FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy

Tiziana Life Sciences (NASDAQ:TLSA) has received FDA approval for its Phase 2a Investigational New Drug (IND) application to study intranasal foralumab in Multiple System Atrophy (MSA) patients. The six-month, open-label clinical trial will evaluate foralumab, a fully human anti-CD3 monoclonal antibody, for its effects on microglial activation, clinical outcomes, and safety.

MSA is a rare, rapidly progressive neurodegenerative disorder with no FDA-approved treatments. The disease affects 1.9-4.9 per 100,000 people worldwide, with a median survival of 6-9 years. The trial (NCT06868628) will administer foralumab via nasal spray in eight 3-week dosing cycles, targeting T-cell mediated neuroinflammation.

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