Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY announced that the investigational candidate sarilumab met both co-primary efficacy endpoints in a phase III study (SARIL-RA-TARGET) for rheumatoid arthritis (RA).
The SARIL-RA-TARGET study is a part of the broad phase III SARIL-RA program on sarilumab being conducted on patients suffering from moderate-to-severe RA, who respond inadequately to either methotrexate or TNF-alpha inhibitor therapy. The study evaluated the efficacy and safety of two subcutaneous doses of sarilumab (200 mg and 150 mg) versus placebo, in combination with non-biologic disease modifying anti-rheumatic drugs (DMARD) in RA patients, who respond inadequately or are intolerant to TNF-alpha inhibitors.
Patients in both sarilumab arms showed clinically relevant and statistically significant improvements in the co-primary endpoints compared to the placebo arm – at 12 weeks patients treated with sarilumab showed better physical function compared to placebo and at 24 weeks patients receiving sarilumab achieved greater improvement in signs and symptoms of RA in comparison to placebo.
Concurrently, with data from the SARIL-RA-TARGET study, Regeneron and Sanofi reported that two other studies on sarilumab – SARIL-RA-EASY and SARIL-RA-ASCERTAIN – met their primary endpoints. While SARIL-RA-EASY evaluated the technical performance and usability of the sarilumab autoinjector device, SARIL-RA-ASCERTAIN evaluated the safety of two subcutaneous doses of sarilumab and Actemra in combination with DMARDs in RA patients, who respond inadequately or are intolerant to TNF-alpha inhibitors.
With the announcement of its first-quarter 2015 results, Regeneron stated that along with Sanofi it intends to submit a biologic license application for sarilumab in the U.S. by 2015-end.
We note that Xeljanz is already approved for the treatment of moderately-to-severely active RA in patients who respond inadequately or are intolerant to methotrexate. Meanwhile, Galapagos NV GLPG is evaluating filgotinib in the DARWIN 1 and DARWIN 2 phase IIb studies for the treatment of RA.