FDA clears foralumab nasal spray for expanded use in Alzheimer’s

Dosing of first patient is expected to happen this month

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Foralumab, an investigational nasal spray being developed by Tiziana Life Sciences, has been cleared by the U.S. Food and Drug Administration (FDA) for expanded use to treat moderate Alzheimer’s disease, and the first patient is expected to be dosed soon.

An expanded use program, also called a compassionate use program, gives a patient access to an unapproved medication outside clinical testing when all other available options have been exhausted or failed to work well.

“I am excited to treat this first patient with moderate [Alzheimer’s] with nasal foralumab as early as July,” Howard L. Weiner, MD, principal investigator and chairman of Tiziana’s scientific advisory board, said in a company press release. Weiner also co-directs the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a member of the Mass General Brigham Healthcare System that will oversee a planned Phase 2 study of foralumab in early Alzheimer’s cleared last year by the FDA.

“This additional FDA clearance allows Tiziana to also study intranasal foralumab in patients with moderate Alzheimer’s … who do not qualify for approved therapies,” said Gabriele Cerrone, acting CEO and founder of Tiziana.

Neuroinflammation, or inflammation of the nervous system resulting from the accumulation of clumps of toxic proteins in the brain and spinal cord, is a hallmark indicator and possibly a driver of Alzheimer’s and other neurodegenerative diseases.

Microglia, the immune cells that scavenge the brain and spinal cord for damage, appear to be overly reactive to lasting neuroinflammation. In Alzheimer’s, microglia collect around the toxic amyloid plaques that form between nerve cells, fueling neuroinflammation and contributing to the gradual loss of nerve cells.

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What is foralumab?

Foralumab is an antibody designed to block CD3, a protein on the surface of immune T-cells. Blocking CD3 reduces the number of effector T-cells, which release inflammatory molecules in response to a potential threat, and increases regulatory T-cells, which keep the immune system from overreacting. This should ease neuroinflammation.

“Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying [mechanism] by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain,” Cerrone said.

In a preclinical study with a mouse model of Alzheimer’s, foralumab calmed overly reactive microglia and improved spatial learning and memory regardless of the amount of toxic amyloid plaques that had accumulated. This suggests foralumab may help ease symptoms of Alzheimer’s by tackling neuroinflammation.

Tiziana is also testing foralumab for other neurodegenerative diseases, such as multiple sclerosis (MS), and is running a Phase 2 study (NCT06292923) in adults with nonactive secondary progressive MS.

Most patients who took foralumab nasal spray for at least six months as part of an expanded use program for nonactive secondary progressive MS saw a reduction in microglia activity in the brain. Patients also reported less fatigue, a common symptom of MS.

“Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient,” Weiner said.