A second patient with nonactive secondary progressive multiple sclerosis (SPMS) showed additional improvements following treatment with foralumab, according to a press release from Tiziana Life Sciences, the developers of the treatment. The patient had already shown clinical improvements in September 2022.
“The sustained improvement in EDSS score starting at 6 months and further improving after 11 months on foralumab treatment in patient EA2 is impressive and warrants further study in a phase 2 trial,” said Tanuja Chitnis, MD, the Principal investigator of the study.
Read more about SPMS
The severity of the patient’s disability was measured using the Expanded Disability Status Scale (EDSS), the standard clinical outcome assessment where a higher score indicates increased disability.
Before the start of the treatment, the patient’s EDSS score had worsened from 3.5 in 2018 to 6.0 in 2021. Eight months following the initiation of foralumab, the patient’s score was reduced to 5.5 and to 5.0, 3 months later.
Howard L. Weiner, MD, the chairman of Tiziana’s scientific advisory board said, “It is gratifying to see a 1.0 EDSS improvement in patient EA2 following treatment with intranasal foralumab.”
A total of 6 patients are enrolled in the study, an expanded access program for intranasal foralumab.
Foralumab is a human anti-CD3 monoclonal antibody that targets the T cells and modulates the immune response. Previous research has shown that it is able to reduce the release of cytokines after intravenous administration. Moreover, intravenous foralumab was well-tolerated and led to a clinical response in patients with COVID-19.
SPMS is a form of MS that is characterized by the progressive worsening of neurologic function over time. The disease can be nonactive or active where relapses and/or new magnetic resonance imaging activity is present. Most disease-modifying treatments for MS are not effective in SPMS.
Tiziana Life Sciences announces additional clinical improvements in the second patient with non-active secondary progressive multiple sclerosis (SPMS) after eleven months of dosing with intranasal foralumab. News release. Tiziana Life Sciences; January 3, 2023.