Tiziana Life Sciences Ltd. announced a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a treatment developed by Tiziana Life Sciences. Delivery Device Training materials have been developed and refined in collaboration with the FDA, and patients will be trained in the use of the nasal device in accordance with these materials.

Intranasal ForalUMab, a novel biologic therapy, has demonstrated remarkable potential in the management of multiple sclerosis. The FDA's decision to allow patients to self-administer this treatment at home marks a significant advancement in the accessibility and convenience of care for those living with this challenging condition. 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 is expected to start screening in November of 2023.

Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.