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

Core Viewpoint - Tiziana Life Sciences has received FDA approval for the IND of its Phase 2a clinical trial of intranasal foralumab for treating Multiple System Atrophy (MSA), addressing an unmet medical need in this orphan disease [1][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [6][7]. - The company's lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in previous studies [6][7]. Clinical Trial Details - The Phase 2a study is a six-month, open-label trial aimed at evaluating the effects of intranasal foralumab on microglial activation, clinical outcomes, and safety in MSA patients [2]. - Foralumab is administered via nasal spray in eight 3-week dosing cycles, targeting T-cell mediated neuroinflammation [2]. Disease Context - Multiple System Atrophy is a rapidly progressive neurodegenerative disorder with a mean incidence of 0.6 per 100,000 person-years in the US, increasing to 3 per 100,000 for individuals aged 50 and older [3]. - The disease leads to severe disability and has a poor prognosis, with a median survival of 6-9 years [3]. Mechanism of Action - Foralumab induces regulatory T cells and modulates T-cell-driven inflammation, potentially slowing neuronal damage in neuroinflammatory and degenerative diseases [4]. - The therapy aims to impact microglial activity and clinical outcomes significantly over the trial period [4].