Lilly, Incyte Post Top-Line Phase 3 Data For Baricitinib In RA

Eli Lilly & Co. and its partner Incyte announced positive top-line results from the late-stage trial of baricitinib in moderately-to-severely active rheumatoid arthritis (RA).

Baricitinib is a once-daily, oral, selective inhibitor of the enzymes JAK1 and JAK2. The drug’s mechanism of action is considered to be effective in the treatment of a wide range of inflammatory conditions and autoimmune diseases driven by JAK-dependent cytokines. Baricitinib possesses approximately a hundredfold potency of JAK1 and JAK2 inhibition compared to JAK 3 in kinase assays. Lilly and Incyte are currently investigating the drug in a late-stage study for RA and Phase 2 development for diabetic nephropathy and psoriasis.

The Phase 3 RA-BEACON study enrolled patients with moderate to severe RA who have previously failed treatment with one or more tumor necrosis factor (TNF) inhibitors and who were taking disease-modifying anti-rheumatic drug (cDMARD) therapy. The study also included a high percentage of patients who also underwent prior treatment with one or several non-anti-TNF biologic patients. Results show that the drug met the primary endpoint of improved ACR20 response versus placebo at the 12 week milestone.

David Ricks, Lilly SVP and president of Lilly Bio-Medicines, said, “People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments. These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition.”

Rich Levy, chief drug development and medical officer at Incyte Corporation, said that the company is delighted with the strong results demonstrated by baricitinib in the late stage trial. He adds, “Over the next 12 months we look forward to seeing the data from additional Phase 3 studies of baricitinib in rheumatoid arthritis, including patients who have had an inadequate response to conventional DMARDs and in those with earlier stage disease.”

The companies said they will present the detailed results of the ongoing late-stage studies in 2015.

Incyte has been actively pursuing partnerships to develop its potential drug leads. Earlier this year, the company inked a deal to develop its lead drug into a combination immunotherapy with Bristol-Myers Squibb’s nivolumab against multiple tumor types. In August, the company entered into partnership with Roche company Genentech to investigate a combo immunotherapy against non-small cell lung cancer (NSCLC).