Core Insights - Tiziana Life Sciences has initiated its first patient dosing in an early Alzheimer's disease Phase 2 trial, marking a significant milestone for the company [1][4] - The FDA has approved the inclusion of both drug-naive patients and those previously treated with anti-amyloid therapies in the trial [1][7] Company Developments - The lead candidate, foralumab, is a fully human monoclonal antibody targeting CD3, aimed at reducing neuroinflammation associated with various neurodegenerative diseases [2][5] - Tiziana currently has three Phase 2 trials in progress for secondary progressive multiple sclerosis (SPMS), multiple system atrophy (MSA), and Alzheimer's, with a fourth trial for ALS expected to start in January [2][6] - Topline data readouts for all ongoing trials are anticipated in 2026, although the ALS study may extend into early 2027 depending on enrollment [2][10] Trial Details - The Phase 2 trial for Alzheimer's aims to assess the effects of foralumab both as a standalone treatment and in conjunction with existing anti-amyloid therapies [6][7] - The company believes that patients on anti-amyloid therapies still experience significant neuroinflammation, which they hope to address with foralumab [8] - The SPMS trial is particularly noteworthy as there are currently no approved therapies for this condition, and the company has received fast track designation from the FDA for this indication [9][10]