Tuesday, Tiziana Life Sciences Ltd. (TLSA) announced that the FDA has accepted its submission for Fast Track Designation for intranasal foralumab to treat non-active, secondary-progressive multiple sclerosis or na-SPMS.
The company stated that the Fast Track Designation application incorporated data from animal studies and clinical insights from the Intermediate-Sized Patient Population Expanded Access initiative. This information demonstrated maintenance of disease stability in all ten patients within six months and a notable decrease in fatigue scores for 70% of the patients.
Foralumab, a human anti-CD3 monoclonal antibody, is a potential biological drug that attaches to the T cell receptor aiming to decrease inflammation by adjusting T cell activity, consequently dampening effector characteristics in different types of immune cells.
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