Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana’s intranasal Foralumab under an Intermediate-Size Patient Population Expanded Access IND. The agency evaluated data from treatment of two initial SPMS patients who received 50 μg of intranasal Foralumab 3 times per week prior to authorizing treatment with the same regimen for the additional patients. Patient enrollment is expected to begin in July 2022.
Foralumab is a human anti-CD3 monoclonal antibody that the company is developing for several delivery methods, including nasal delivery. Tiziana previously reported data showing that six months of treatment with the nasal formulation inhibited microglial cell activation throughout the brain of an SPMS patient. The company has also previously published positive results from a pilot study of intranasal Foralumab in mild to moderate COVID-19.
Tiziana Scientific Advisory Board Chair Howard Weiner, Director of the Multiple Sclerosis Program at the BWH said, “Treatment with intranasal Foralumab is a novel physiological approach to stimulate the mucosal immune system to induce disease-modifying benefits in the CNS by dampening microglial inflammation. 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. This now opens the door to treat other neurologic diseases which have microglial inflammation – such as Alzheimer’s disease – with intranasal Foralumab.”
Read the Tiziana Life Sciences press release.
