LONDON (Alliance News) - Tiziana Life Sciences PLC on Wednesday said it has submitted an application in the US to begin a phase one trial of its autoimmune and inflammatory disease drug Foralumab.
The investigational new drug application was filed with the US Food & Drug Administration and will allow the life sciences company to trial Foralumab capsules in healthy volunteers.
Foralumab is currently in development as a treatment for autoimmune and inflammatory diseases such as non-alcoholic steatohepatitis and non-alcoholic fatty liver disease, both of which are liver conditions not caused by alcohol.
The single-site clinical study is expected to have 36 subjects and will evaluate Foralumab's safety and tolerability, as well as its effect on immune system.
Tiziana Chief Executive & Chief Scientific Officer Kunwar Shailubhai said: "Our approach, administering Foralumab orally for site-targeted clinical responses while improving efficacy and minimizing toxicity, can be a game changing treatment option for [nonalcoholic steatohepatitis] and other autoimmune diseases. We are excited about the successful development of a proprietary oral formulation and submission of this [investigational new drug] application, which represent major milestones for advancing this groundbreaking approach forward."
Shares in Tiziana were down 2.3% at 42.00 pence on Wednesday.