According to Tiziana Life Sciences, the FDA has approved the company’s IND for a Phase 2a trial of intranasal foralumab in patients with multiple system atrophy (MSA). The company is currently developing intranasal foralumab for the treatment of secondary progressive multiple sclerosis (SPMS) and for the treatment of Alzheimer’s disease. Tiziana recently announced that it had submitted an IND for a Phase 2 study of the nasal spray for the treatment of amyotrophic lateral sclerosis (ALS).
The new Phase 2a open-label study is expected to enroll 5 MSA patients who will be observed for 6 months and then will receive intranasal foralumab in dosing cycles of 3 times a week for 2 weeks followed by a week without a dose, with the cycle repeated 8 times. The primary endpoint in change in symptoms from the end of the 6-month observation period to the end of the 6-month dosing period.
Tiziana CEO Ivor Elrifi commented, “Foralumab administered intranasally induces regulatory T cells and modulates T-cell-driven inflammation. Its ability to reduce microglial activation presents a promising therapeutic strategy to slow neuronal damage in neuroinflammatory and degenerative diseases such as Multiple Sclerosis, Alzheimer’s Disease, ALS, and MSA. This novel, non-systemic approach is designed to engage regulatory T cells, promoting immune tolerance while minimizing systemic immune suppression.”
Read the Tiziana Life Sciences press release
