The U.S. Food and Drug Administration (FDA) approved a request to use the antibody — a fully human anti-CD3 monoclonal antibody called foralumab — under an Individual Patient Expanded Access Program, the therapy’s developer, Tiziana Life Sciences, announced in a press release.
Treatment is expected to begin by late June, and last for six months.
Foralumab binds to the CD3 receptor on immune T-cells to calm the immune response. This approach could potentially treat a wide range of autoimmune and inflammatory diseases, including progressive forms of MS.
Initially developed to be delivered orally, Foralumab was reformulated for nasal delivery by Howard Weiner, MD, director of the Multiple Sclerosis Program at the Brigham and Women’s Hospital (BWH) in Boston.
“Nasal anti-CD3 is an exciting, novel approach that has the ability to provide a safe treatment for a form of MS that has no effective treatment. We are pleased that the FDA has allowed us to treat a patient with SPMS who needs a better treatment option than is currently available,” Weiner said.
The person will be treated and evaluated for safety at BWH, and undergo neurological and imaging tests. Changes in immunological and neurodegenerative markers will also be assessed.
A Phase 1 clinical trial, now complete, tested a nasal spray formulation of foralumab, given at ascending doses of 10, 50, and 250 micrograms once daily for five consecutive days to healthy volunteers. Results showed the therapy was well-tolerated, with no treatment-related safety issues reported at any dose. According to the company, biomarker analysis showed significant positive immune effects.
Tiziana also plans to initiate a Phase 2 clinical trial of nasally administered foralumab in progressive MS this year.
“New treatments for progressive MS are urgently needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease,” said Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at BWH.
Foralumab is also being developed and tested for other conditions, and in various formulations. In a clinical study in Brazil, it was given as a nasal spray to people with COVID-19 infections, and data suggest its use significantly reduced lung inflammation, Tiziana reported.
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