Intranasal Foralumab Provides Neuroimaging and Clinical Improvements in Secondary Progressive Multiple Sclerosis

In the expanded access program, after 3 months of intranasal foralumab (Tiziana Life Sciences, New York, NY) treatment of secondary progressive multiple sclerosis (SPMS), a second participant showed clinical improvement on Positron Emission Tomography (PET) imaging analysis, neurologic examination, and the Timed 25-Foot Walk test. These improvements were consistent with results of treatment seen in the first participant. Based on these results, the FDA has allowed enrollment of 8 additional participants.

The second participant was diagnosed with SPMS in 2014 with resulting disability accumulation.
After 3 months of treatment with intranasal foralumab (50 mcg; 3 times a week for 2 weeks, followed by 1 week off treatment) PET imaging was used to evaluate inhibition of microglia, a key marker of brain inflammation. The PET signal was reduced by 10% to 30% in the cerebellum, thalamus, white matter, and cortex.

Both participants are continuing treatment in this trial. The dose will remain the same for newly enrolled participants with the added option to increase the dose up to 100 mcg to improve clinical benefit.

Dr. Howard Weiner, MD, director of the Multiple Sclerosis Program at BWH and chairman of Tiziana's Scientific Advisory Board, commented "We are very pleased by both the biologic and clinical improvement observed in the second patient after treatment with intranasal foralumab for 3 months, which provides confirmation that the intranasal dosing modulates the systemic immune response and in turn dampens brain inflammation. It is encouraging to see the consistency of response between the first and second patient and that the treatment was well tolerated."

Tarun Singhal, MD, director of PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at BWH commented, “Our current analyses suggest a consistency of response to intranasal foralumab, across the first two SPMS patients. We were also able to harmonize data across scanners and institutions, which has yielded very encouraging results. We look forward to our continued investigations of foralumab in SPMS patients, using additional PET analytical approaches.”