Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy

Core Insights - Tiziana Life Sciences has initiated a Phase 2a clinical trial for intranasal foralumab in patients with Multiple System Atrophy (MSA), marking a significant step in developing therapies for this rare neurodegenerative disorder [1][3]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly through nasal administration [9]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, demonstrating a favorable safety profile and clinical response in prior studies [9][7]. Clinical Trial Details - The Phase 2a trial will evaluate the efficacy of foralumab in reducing neuroinflammation and aims to determine its potential to slow disease progression and improve quality of life for MSA patients [3][4]. - The trial involves a six-month open-label study with participants receiving treatment over eight dosing cycles [3]. Disease Context - Multiple System Atrophy is a rare and rapidly progressive neurodegenerative disorder affecting an estimated 15,000–50,000 individuals in the U.S., with no FDA-approved treatments available to alter its course [2][5]. - The disease leads to severe movement, balance, and autonomic function issues, with most patients surviving only 6–9 years post-diagnosis [5]. Mechanism of Action - Foralumab works by stimulating T regulatory cells through a novel, non-systemic delivery approach, targeting the immune processes that may drive neurodegeneration [4][6]. - Early studies have indicated potential benefits of foralumab in stabilizing or improving function in other neuroinflammatory conditions, such as multiple sclerosis [4][6].