FDA Approves Foralumab Nasal Spray for Expanded Use in Alzheimer’s Treatment

The FDA has approved the use of foralumab nasal spray for treating moderate Alzheimer’s disease. Developed by Tiziana Life Sciences, this investigational treatment will soon be administered to the first patient.

What is Expanded Use?

Expanded use, also known as compassionate use, allows patients to access unapproved medications when no other treatments are effective.

First Patient to be Treated

Dr. Howard L. Weiner, principal investigator and chairman of Tiziana’s scientific advisory board, will treat the first patient with moderate Alzheimer’s using foralumab. Dr. Weiner is also co-director at the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.

The Science Behind Foralumab

Neuroinflammation, caused by toxic protein buildup in the brain and spinal cord, is a key factor in Alzheimer’s and other neurodegenerative diseases. Microglia, the brain’s immune cells, become overactive in response to this inflammation.

Foralumab is an antibody that blocks CD3, a protein on immune T-cells. This reduces inflammatory T-cells and increases regulatory T-cells, which helps reduce neuroinflammation.

Potential Impact on Alzheimer’s

Foralumab could be a groundbreaking treatment for Alzheimer’s. In preclinical studies, it calmed overactive microglia and improved memory and learning in mice, regardless of the amount of toxic amyloid plaques present.

Foralumab in Other Treatments

Tiziana is also testing foralumab for multiple sclerosis (MS). A Phase 2 study is underway for nonactive secondary progressive MS. Patients using the nasal spray for at least six months reported reduced brain inflammation and less fatigue.

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Conclusion

The approval of foralumab nasal spray for moderate Alzheimer’s offers hope for patients and their families. Continued research and trials will determine its effectiveness in slowing cognitive decline.

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References

• U.S. Food and Drug Administration (FDA)
• Tiziana Life Sciences press release
• Ann Romney Center for Neurologic Diseases
• Brigham and Women’s Hospital
• Centers for Disease Control and Prevention (CDC)