GSK Advances Sirukumab into Phase III DevelopmentBy
GlaxoSmithKline (GSK) has begun a Phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA), a type of vasculitis (inflammation of blood vessels), results in inflammation of large and medium-sized arteries.
Sirukumab is an investigational human anti-IL-6 monoclonal antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that is believed to play a role in autoimmune conditions. It is in Phase III development for rheumatoid arthritis (RA) and GCA.
As part of a collaboration with Janssen Biologics (Ireland) [Janssen], a Phase III program began in August 2012 to investigate sirukumab for the treatment of moderately to severely active RA. The licensing and co-development collaboration agreement, which was entered into by GSK and Janssen in December 2011, gives both companies the option to investigate sirukumab for other indications beyond RA. The Phase III study investigating sirukumab for GCA is fully funded and sponsored by GSK. Janssen has the right to opt into the GCA program at any stage of development.