- GlaxoSmithKline (GSK) claims that it has encouraging phase 3 results for its sirukumab, an anti-interleukin 6 (IL-6) monoclonal antibody in development for treatment of rheumatoid arthritis (RA).
- GSK is co-developing sirukumab with Janssen as part of a partnership dating back to December 2011.
- To date, there have been no safety-related red flags.
The phase 3 trials for sirukumab, SIRROUND-D, -H and -T are the basis for the drug's regulatory filing for an RA indication in 2016. These trials, which include roughly 3,000 patients, aim to capture as much long-term efficacy and safety data as is needed for a solid application. GSK hopes sirukumab will be a blockbuster drug when it reaches market.
Last month, Biopharma Dive published a feature which explored advancements in the standard of care in RA. It's clear that although there are numerous synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), there is still space for other types of treatment.
For that exact reason, GSK has been developing sirukumab, while Lilly is at work on baricitinib. Several other firms also have promising RA candidates in development. Sanofi and Regeneron have already filed for their candidate sarilumab, while Alder Biopharmaceuticals is searching for a partner for development of clazakizumab.
Not all patients respond to first- or even second-line treatments, such as methotrexate or an anti-TNF inhibitor, making treatment of RA challenging. Additional treatment options are needed for those patients, in addition to therapies that can be used as part of combo-treatment regimens.