A new therapy being developed by GlaxoSmithKline and Janssen as a treatment for rheumatoid arthritis has passed late-stage clinical safety and efficacy tests, paving the way for regulatory filings next year.
The UK drugs giant said it has banked positive top-line results from the Phase III programme investigating the human anti-interleukin 6 monoclonal antibody sirukumab for the treatment of patients with moderately to severely active rheumatoid arthritis.
The programme consists of three studies, the first of which, SIRROUND-T, includes patients with active RA despite anti-tumor necrosis factor (TNF)-alpha therapy. The second, SIRROUND-D, involves patients with active RA despite taking disease modifying anti-rheumatic drugs (DMARDs), and the third, SIRROUND-H, compared subcutaneous sirukumab with adalimumab (an anti-TNF monoclonal antibody), in biologic naïve patients intolerant, unable to take, or unresponsive to methotrexate.
Full results from these three pivotal studies will be presented at forthcoming scientific conferences and submitted for publication in peer-reviewed journals, GSK said, but also stressed that there were no unexpected safety findings relative to the known effects of anti-IL-6 inhibitors.
Janssen and GSK formed a co-development and co-commercialisation pact for sirukumab in RA back in 2011. The agreement allows both companies the option to investigate the drug for other indications beyond RA; GSK is also testing sirukumab in a Phase III trial involving patients with Giant Cell Arteritis.