Tiziana Life Sciences has announced the submission of an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA) for an oral formulation of Foralumab, used for the treatment of autoimmune and inflammatory diseases such as nonalcoholic steatohepatitis (NASH).
The submission is to initiate a Phase I clinical trial of enteric-coated capsules of the drug, a fully human anti-CD3 monoclonal antibody (mAb), in healthy volunteers.
The clinical study is expected to enroll 36 subjects and it will be conducted at the Brigham and Women's Hospital (BWH), Harvard Medical School.
The primary objective of this study is to evaluate safety, tolerability and immunomodulatory effects of orally administered Foralumab in healthy volunteers. It will also investigate the established biomarkers with anti-inflammatory effects and stimulation of T regulatory cells.
After the study, assuming success the company also plans to launch additional clinical trials to study the potential of the oral administration of Foralumab in NASH, non-alcoholic fatty liver disease NAFLD and Crohn’s Disease.
“Our approach, administering Foralumab orally for site-targeted clinical responses while improving efficacy and minimising toxicity, can be a game changing treatment option for NASH and other autoimmune diseases. We are excited about the successful development of a proprietary oral formulation and submission of this IND application, which represent major milestones for advancing this groundbreaking approach forward,” said Kunwar Shailubhai, chief executive officer & chief scientific officer of Tiziana.