Tiziana Life Sciences (TLSA), a biotechnology company, on Tuesday released positive clinical data from the ongoing expanded access program for intranasal Foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS).
Foralumab, a human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally and is being advanced in treating progressive forms of multiple sclerosis. In 2024 intranasal foralumab was granted a breakthrough designation from the FDA.
Results from the expanded access program were updated from March 2025. The study dosed 14 patients of na-SPMS and observed the effects over 6 months. Data suggests a stabilization of disability, as measured on the expanded disability status scale (EDSS), and a 64% improvement in fatigue, as measured on the modified fatigue impact scale (MFIS).
Additionally, the drug showed better EDSS and MFIS scores than the placebo and standard-of-care drug tolebrutinib. The company also reported that intranasal foralumab was found to have a favorable safety and tolerability profile.
Intranasal foralumab is being evaluated in an ongoing Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial.
TLSA is currently trading at $1.42, up 2.90%.
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