Tiziana Life Sciences Ltd (NASDAQ:TLSA) unveiled new quantitative PET imaging data on foralumab at the Annual Meeting of the American Academy of Neurology in Denver.
The company presented data from its platform presentation titled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS.”
Tiziana’s presentation showcased encouraging quantitative imaging data from foralumab's intermediate-size patient population Expanded Access Program.
Foralumab, a fully human anti-CD3 monoclonal antibody, modulates T cell function to suppress inflammation, offering a novel treatment approach for neuroinflammatory and neurodegenerative diseases like multiple sclerosis and COVID-19.
Foralumab exhibited a reduction in microglial activation and disease stabilization in non-active secondary progressive multiple sclerosis patients with disease progression independent of relapse, as observed through positron emission tomography (PET) imaging.
Moreover, clinically relevant improvements were observed in patient-reported outcomes, including stability in Expanded Disability Status Scale scores and improvements in fatigue levels measured by the Modified Fatigue Impact Scale.
Gabriele Cerrone, chairman and acting CEO of Tiziana Life Sciences, emphasized the significance of these findings, particularly in addressing the unmet need for effective treatments in progressive MS subsets.
“Tiziana is taking a leadership role in focusing on this subset of progressive MS where there are no effective treatments,” Cerrone said in a statement.
As Cerrone explained, microglial cell activation is believed to be a contributing factor to non-active secondary progressive multiple sclerosis with progressive independent of relapse, but historically, there have not been reliable markers to detect this in humans.
However, the novel imaging technique using [F18]PBR06-PET allows for the visualization of active microglia, providing evidence of their involvement and the potential to measure changes in the immune system in na-SPMS patients through PET scans.
“The mechanism of action seen thus far with foralumab is significant since a major unmet need in MS is developing therapy for na-SPMS with PIRA and being able to dampen associated neuro inflammation,” the CEO added.
Tiziana has initiated a double-blind, placebo-controlled, dose-ranging study of nasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint.