Tiziana Life Sciences has announced the initiation of a Phase 2 trial of intranasal foralumab in patients with early-stage Alzheimer’s disease. In June 2024, Tiziana said that it had received approval for the use of the nasal spray in a patient with moderate Alzheimer’s under an expanded access IND. In September 2024, the company announced that it had received a $4 million grant from the National Institutes of Health to study the use of foralumab for this indication.
The Phase 2 trial in AD patients will compare intranasal foralumab alone to intranasal in combination with lecanemab or donanemab, which are currently approved intravenous therapies designed to reduce amyloid in the brain. Foralumab is expected to reduce neuroinflammation, and TSPO-PET imaging will be used to measure neuroinflammation levels.
Tiziana is developing intranasal foralumab for several other neurologic diseases, including secondary progressive multiple sclerosis (SPMS), amyotrophic lateral sclerosis (ALS), and multiple system atrophy. In February 2025, the company announced that it had contracted with CDMO Renaissance Lakewood (now LTS) for development services.
Tiziana CEO Ivor Elrifi commented, “With enrollment now underway and baseline neuroimaging and biomarkers secured, we are on the verge of testing a fundamentally new approach to Alzheimer’s, one that treats the chronic brain inflammation that is associated with ongoing neurodegeneration. . . .This milestone marks an important step toward testing whether immune modulation alone, or in combination with amyloid removal, can achieve disease modification. The PET evidence of inflammation in AD with or without anti-amyloid treatment provides a clear biological rationale for this innovative strategy.”
Read the Tiziana Life Sciences press release
