Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Friday that a patient with moderate Alzheimer’s disease showed a marked reduction in brain inflammation after three months of treatment with its lead drug candidate, intranasal foralumab, under an expanded access program.
A PET scan revealed a significant decrease in microglial activation, an indicator of neuroinflammation linked to Alzheimer’s progression, according to data presented by Dr Howard Weiner at the 2025 AD/PD Conference in Vienna.
The company said the findings mark a key milestone in its efforts to develop treatments that target immune pathways in neurodegenerative diseases.
Tiziana’s foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate immune responses by inducing regulatory T cells (Tregs) that can dampen inflammation in the brain.
“There has been a substantial drop in TSPO signal over the three-month period, suggesting that the foralumab treatment might be reducing microglial activation, and this is highly encouraging,” said Dr Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital. “This suggests that Foralumab may play a crucial role in mitigating neuroinflammation in Alzheimer's patients.”
Dr Weiner added that the patient has not reported any side effects during the course of the study.
Microglial activation is increasingly seen as a critical driver of neurodegenerative disorders, including Alzheimer's, multiple sclerosis (MS), and Parkinson’s disease. In Alzheimer’s, it is believed to work alongside beta-amyloid and tau proteins in accelerating disease progression.
Tarun Singhal, director of the PET Imaging Program in Neurologic Diseases at Brigham and Women’s, said the reduction in brain inflammation observed via PET scan was “remarkable,” and consistent with prior results in patients with secondary progressive MS treated with the same therapy.
Tiziana’s CEO Dr Ivor Elrifi said the data “underscores our commitment to advancing innovative treatments for Alzheimer’s disease,” particularly in the moderate stage where there are currently no approved therapies.
Executive chairman Gabriele Cerrone added the PET scan results demonstrate the broader potential of foralumab in treating neurological conditions by targeting neuroinflammation, building on data from the company’s MS program.
Alzheimer’s disease affects more than 50 million people globally, a number projected to triple by 2050. Current therapies focus largely on reducing amyloid plaques, but growing evidence suggests inflammation plays a key role in cognitive decline.
Shares of Tiziana were up around 5.3% at $1.59 on Friday afternoon.