Tiziana Life Sciences (NASDAQ:TLSA, AIM:TILS) submitted an IND to the FDA for its enteric-coated capsules of Foralumab, an anti-CD3 monoclonal antibody.
Foralumab, believed to induce an anti-inflammatory response by stimulating regulatory T-cells, is being developed for the treatment of autoimmune and inflammatory diseases.
Tiziana plans to initiate a Phase 1 clinical study to evaluate the safety, tolerability and immunomodulatory effects of orally administered Foralumab in healthy volunteers, followed by additional clinical trials to study the drug’s potential in nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease and Crohn’s disease.
