FDA Clears Intranasal Foralumab for Clinical Investigation as a Potential Treatment for Alzheimer Disease

Tiziana Life Sciences’ (New York, NY) investigational new drug (IND) application for intranasal foralumab has been cleared by the Food and Drug Administration (FDA), authorizing further investigations into the agent’s potential as a therapy to treat people with Alzheimer disease (AD). Foralumab is a fully human anti-CD3 monoclonal antibody (mAb), which binds to the T cell receptor and reduces inflammation through T cell function modulation.

Previous studies in patients with COVID-19 infection have demonstrated that administration of intranasal foralumab suppressed effector features in multiple immune cell subsets, including serum IL-6 and C-reactive protein, when compared with controls.

Howard L. Weiner, Professor of Neurology at Harvard Medical School commented, “Foralumab shows great promise in targeting the pathological hallmarks of the disease, and I am optimistic about its potential to offer a breakthrough treatment option for patients suffering from this devastating condition. I look forward to witnessing the progress of this important therapy.”

Both the intranasal administration method of foralumab and its mechanism of action in targeting inflammation are first in class. Phase 2 trials are expected to start before the end of 2023.