Tiziana Life Sciences Ltd (NASDAQ:TLSA) has unveiled additional positive results from its Expanded Access Program for patients with non-active secondary progressive Multiple Sclerosis (na-SPMS).
The clinical-stage biopharmaceutical company said patients treated with its investigative therapeutic intranasal foralumab demonstrated multiple improvements, with 70% showing an improvement in fatigue after six months of follow-up.
All patients enrolled in the study had previously clinically progressed on ocrelizumab, a medication used to treat MS.
“All 10 foralumab-treated patients stabilized or improved in key clinical measures, and seven showed clinical meaningful improvement in their fatigue at six months as measured by the MFIS,” principal investigator Dr. Tanuja Chitnis said.
“Other key clinical outcome measures included the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk Test (T25WT) and Pyramidal Scores in a disease state that typically shows a decline in function over time.”
Gabriele Cerrone, Tiziana CEO and founder, highlighted that fatigue is a challenging symptom for individuals with MS, negatively impacting their daily life.
“The clinically meaningful improvement in fatigue levels seen in seven out of ten patients, as well as the stabilization or improvements in other key clinical outcome measures that were seen in all patients, underscores the potential of Tiziana's investigational therapy to address this critical unmet need,” Cerrone said.
Tiziana’s foralumab is the only fully human anti-CD3 monoclonal antibody (mAb). It binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.
The company believes immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treating neuroinflammatory and neurodegenerative diseases.