Tiziana Life Sciences Ltd (TLSA) News & EventsTLSATiziana Life Sciences Ltd

Tiziana Life Sciences Begins Alzheimer's Clinical Trial

Tiziana Life Sciences announced that the last patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early/mild Alzheimer's disease, or AD. Topline data are anticipated to be announced in Q1 2027.

Tiziana Life Sciences Submits Orphan Drug Application

Tiziana Life Sciences announced that it has submitted a request to the U.S. Food and Drug Administration, FDA, for Orphan Drug Designation, ODD, for intranasal foralumab for the treatment of Multiple System Atrophy, MSA. Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: "Filing for Orphan Drug Designation for intranasal foralumab in MSA represents an important regulatory step as we advance this novel therapy for patients facing a devastating disease with no approved disease-modifying options. Foralumab administered intranasally induces regulatory T cells and modulates T-cell-driven inflammation. Its ability to reduce microglial activation offers a promising strategy to slow neuronal damage in neuroinflammatory and neurodegenerative conditions including MSA. This non-systemic approach is designed to promote immune tolerance while minimizing systemic immune suppression."

Tiziana Life Sciences Completes First Doses in ALS Clinical Trial

Tiziana Life Sciences announced that the first three participants have all received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial. The BANYAN Trial is evaluating intranasal foralumab in people living with amyotrophic lateral sclerosis.