by Marta Figueiredo PhD | April 12, 2022
Based on findings from the first two secondary progressive multiple sclerosis (SPMS) patients given foralumab nasal spray, an experimental therapy, the U.S. Food and Drug Administration (FDA) has approved starting treatment in up to eight other patients under a special access program.
Those enrolled in this intermediate-size expanded access program — anticipated to start in July — will receive the immunomodulatory therapy at Harvard Medical School’s Brigham and Women’s Hospital (BWH), similar to the first two patients treated in ongoing single-patient access programs.
“Therapies to slow progression in multiple sclerosis are much needed,” Tanuja Chitnis, MD, the study’s principal investigator, a neurology professor at BWH, and a member of the scientific advisory board of Tiziana Life Sciences, the therapy’s developer, said in a press release.
Foralumab nasal spray comprises “a novel physiological approach to … induce disease-modifying benefits in the CNS [central nervous system; the brain and spinal cord] by dampening microglial inflammation,” said Howard Weiner, MD, director of the Multiple Sclerosis Program at BWH and chairman of Tiziana’s scientific advisory board.
Microglial cells — the CNS’ own immune cells — have been implicated in the abnormal inflammatory and immune responses that drive neurodegeneration in multiple sclerosis (MS).
“The first validation of our innovative approach came from our recently reported results showing positive clinical benefits and microglial modulation in a patient with secondary progressive multiple sclerosis who was treated for six months with nasal foralumab,” Weiner added.
The first single-patient program was approved by the FDA in April 2021, and the second in January. With the agency’s permission, the first patient is continuing treatment for another six months to determine whether the observed benefits can be sustained. Findings after three months of treatment for the second patient are expected in May.
“We are grateful to have the opportunity to offer intranasal foralumab to progressive MS patients,” Chitnis said.