Investigation of Foralumab for Alzheimer Disease Treatment  Will  Continue to Phase 2

Nasally administered foralumab (Tiziana Life Sciences, New York, NY) has showed delays in disease processes underlying the progression of Alzheimer disease (AD)  in animal models . Based on those results, the investigation of foralumab for AD will continue to phase 2 clinical trials. Foralumab is an entirely human antiCD3  monoclonal antibody for the potential treatment of AD and other neurodegenerative  diseases in individuals.

Treatment with foralumab is known to stimulate T regulatory (Tregs) cells, which have the ability to cross the blood-brain barrier. The effect of foralumab in dampening microglial activation led Dr. Howard Weiner’s team at the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Medical Center to evaluate nasally administered foralumab  for both multiple sclerosis (MS)  and AD. Dr. Weiner  discovered that foralumab modulates brain microglia in animal models.

 “Nasal administration of foralumab is a potentially revolutionary approach to treat patients with AD. Preclinical animal studies have established that nasal administration of anti-CD3 can modulate brain microglia and ameliorate disease in animal models. This is a major scientific advancement that provides the basis to move forward with clinical development of nasally administered foralumab in AD,” commented Dr. Weiner, who is the Robert L. Kroc professor of Neurology at the Harvard Medical School, director and founder of the Partners MS Center and Codirector of the Ann Romney Center for Neurologic Diseases at the Brigham & Women’s Hospital. “Targeting microglia with nasal antiCD3 is a first-in-class immunotherapeutic approach to treat AD.”
Trials of nasally and orally administered foralumab for treatment of progressive multiple sclerosis (MS) and Crohn’s disease are currently in phase 2.