Lilly, Incyte’s RA Drug Succeeds in Phase 3 Trial

Eli Lilly and Incyte’s new once-daily rheumatoid arthritis drug baricitinib outperformed the standard care in a Phase 3 clinical trial, putting the drugmakers on track for a regulatory filing this year.  

The 600-patient RA-BEGIN trial met its primary endpoint of noninferiority to methotrexate in patients with moderately to severely active RA, based on an ACR20 response at 28 weeks. The candidate proved superior to methotrexate based on ACR20 response, the firms said.

The results support positive evidence from two earlier Phase 3 studies, part of a larger program tracking baricitinib’s effectiveness in more than 3,000 patients. Results of a fourth study should be released later this year, Lilly says. In addition, the firms have initiated a fifth trial to support regulatory approval in China.

Lilly spokeswoman Celeste Stanley says the drugmakers plan to file an NDA with the FDA for the RA indication by the end of 2015, with other regulatory submissions to follow next year.

Lilly and Incyte partnered in 2009 to develop baricitinib, a JAK 1 and JAK 2 inhibitor drug, and other treatments for inflammatory diseases. Baricitinib is also in Phase 2 development for psoriasis and diabetic nephropathy. — Victoria Pelham