Tiziana Life Sciences Ltd. announced positive findings have been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA) patients. These patients have shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period.

PET scan findings for two additional EA patients (10 total) are planned to be available in late January. Tarun Singhal, M.B.S., M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, commented, " Upon review of the baseline and three-month [F-18] PBR06 PET scans of the two new na-SPMS EA patients, a qualitative reduction in microglial activity was seen in one of two new patients. When combined with my assessment of the first six EA patients at three-months, a total of six out of the eight suggested a reduction in qualitative microglial PET signal.

These findings are promising from an imaging point and further studies are needed to confirm them using additional quantitative approaches". Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.

This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial dosed its first patient in December of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.