Tiziana Life Sciences Ltd (NASDAQ:TLSA) has unveiled new neuroimaging data which shows its investigational drug intranasal foralumab improved White Matter Z-scores in patients with non-secondary progressive Multiple Sclerosis (na-SPMS).
White Matter Z-scores are a statistical measure in neuroimaging studies used to assess the integrity or abnormalities of structures in the brain.
Na-SPMS patients’ White Matter Z-scores were measured from PET images taken three months into treatment with foralumab, the only fully human anti-CD3 monoclonal antibody which bids to the T cell receptor to dampen inflammation.
The data comes from Tiziana's open-label intermediate-sized patient population Expanded Access Program and was presented last week at the American Academy of Neurology Annual meeting.
It showed the dampening of microglial activation, an indicator of brain inflammation, in patients with na-SPMS receiving intranasal foralumab.
“We calculated White Matter Z-scores to measure the effect of intranasal foralumab on microglial activation at baseline and then after foralumab treatment for three months,” investigator Dr Tarun Singhal commented.
“We saw reductions of 28% to 48%, indicating improvement in five out of six patients, and a 36% median reduction in White Matter Z-scores compared to baseline.”
Gabriele Cerrone, Tiziana CEO, thanked Dr Singhal for advancing the company’s intranasal foralumab program and for the insights his work has provided into the foralumab’s effect on brain inflammation.
“We are seeing this additional, encouraging evidence of intranasal foralumab’s effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity (PIRA) at 3 months as evaluated by [F-18]PBR06-PET and was associated with clinical symptom improvement or stability,” Cerrone said.
“Based on these positive results, a double-blind, placebo-controlled, dose-ranging study of intranasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with clinical measures of EDSS (disability) and MFIS (fatigue) is currently underway.”