Tiziana Life Sciences has started the first-in-human Phase 1 clinical trial in healthy volunteers for Foralumab , which will be given to patients using a nasal spray.
Intranasal delivery of therapeutic anti-CD3 mAb is a game changer that employs immune mechanisms overcoming the obstacle of the blood brain barrier and it has the potential as entirely new class of therapies for treatment of a wide range of human diseases”, said Gabriele Cerrone, Chairman and founder of Tiziana.
Dr. Howard Weiner, a member of scientific advisory board of Tiziana explained that nasal administration with anti-CD3 mAbs induces Tregs in the cervical lymph node that then cross the blood brain barrier and provide an interleukin-10 dependent anti-inflammatory signal to downregulate the activated glial cells in brain and return them to their normal homeostatic state.
Kunwar Shailubhai, CEO and CSO of Tiziana said: “Filing this IND for nasal administration of Foralumab is a first and major milestone towards the Company’s objective to develop innovative therapies with alternative routes of administration whilst maximizing efficacy.”
He said that the company plans to submit a similar IND for a Phase 1b clinical trial with encapsulated and enteric-coated formulation of Foralumab, in the first quarter of 2019. “A well-established panel of blood biomarkers will be examined to assess potential of orally administered Foralumab for treatment of autoimmune and inflammatory diseases such as non-alcoholic fatty liver disease (NASH) and Crohn’s disease,” he said.