Tiziana Life Sciences has shared promising six-month results for intranasal foralumab in non-active secondary progressive multiple sclerosis (SPMS).
Affecting approximately 2.8 million people globally, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
SPMS is a stage of MS that comes after relapsing remitting MS for many patients. With this form of the disease, disability steadily worsens and relapses become unlikely.
Tiziana’s foralumab, a fully-human anti-CD3 monoclonal antibody, is designed to bind to the T cell receptor and dampen inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.
The latest results for the therapy showed that 80% of non-active SPMS patients enrolled in an expanded access programme to receive foralumab for at least six months demonstrated qualitative improvements in PET imaging.
Out of the latest cohort of four expanded-access patients, three had findings that suggested a qualitative reduction in the microglial PET signal over the six-month treatment period.
“When combined with my assessment of the first six expanded access patients at six months, eight of the ten suggest a qualitative reduction in microglial PET signal,” explained Tarun Singhal, director of the PET imaging programme in neurologic diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital.
“Further studies are needed to confirm these findings using additional cases and quantitative approaches,” added Singhal, who is also a founding member of Mass General Brigham Healthcare System and associate professor of neurology at Harvard Medical School.
Tiziana recently received an allowance from the US Food and Drug Administration (FDA) for an additional 20 patients to be enrolled in the intranasal foralumab MS expanded access programme, which it said will allow for further data collection and analysis.
Gabriele Cerrone, chairman, acting chief executive officer, and founder of Tiziana, said he was “thrilled” with the results, adding that the company is “rapidly progressing” its intranasal foralumab programme in MS.
The latest analysis comes less than a month after Tiziana submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab in non-active SPMS.