Tiziana Life Starts Testing Nasally Administered Foralumab in Multiple Sclerosis Patients

Under an individual patient expanded access program, Tiziana Life Sciences plc TLSA has dosed the first patient with secondary progressive multiple sclerosis with nasally administered foralumab.
Nasal Foralumab 50 mcg (25 mcg/nostril) will be administered in 3-week cycles, three times/week dosing for the first two weeks followed by one week of a rest period.
The study will continue for six months to evaluate routine safety, tolerability, and neurological behaviors and examine microglial activation by positron emission tomography, immunological and neurodegenerative markers to assess clinical responses.
Previously, Tiziana completed a Phase 1 trial with nasally administered Foralumab in healthy subjects. The treatment was well-tolerated, and no drug-related safety issues were reported at doses of up to 250 mcg.
Subsequently, Tiziana reported positive data from a clinical study with nasally administered Foralumab in COVID-19 patients in Brazil.
Foralumab (formerly NI-0401) is an entirely human anti-CD3 monoclonal antibody.
Price Action: TLSA shares are up 8.2% at $2.5 during the premarket session on the last check Tuesday.