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Baricitinib superior to placebo in reducing rheumatoid arthritis disease activity in second Phase 3 study

Eli Lilly and Company and Incyte Corporation have announced that the investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis (RA). The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug (cDMARD). The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.

“We are encouraged that baricitinib demonstrated statistically significant improvement in rheumatoid arthritis disease activity compared to placebo, now in a second pivotal study,” said David Ricks, Lilly senior vice president, and president of Lilly Bio-Medicines.

Part of an extensive Phase 3 program testing baricitinib in more than 3,000 patients at different stages along the RA treatment continuum, the RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy.

“Despite treatment advances, many people with RA continue to experience active disease, including pain, joint stiffness, disability and progressive joint damage,” said Rich Levy, M.D., chief drug development and medical officer, Incyte Corporation. “These results suggest that baricitinib could provide an additional treatment option for patients who are not responding to conventional drugs.”

In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.

Lilly and Incyte announced top-line results from the first Phase 3 trial of baricitinib, RA-BEACON, which also met its primary endpoint, in December 2014 and plan to present detailed data from both RA-BEACON and RA-BUILD at scientific meetings in 2015.

About Baricitinib

Baricitinib is a once daily, oral, selective JAK1 and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib is currently in Phase 3 clinical development for rheumatoid arthritis and Phase 2 development for psoriasis and diabetic nephropathy.

About Baricitinib Phase 3 Trials

Lilly and Incyte are conducting four pivotal Phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis to support regulatory submission in most countries. An additional Phase 3 study was recently initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate naïve, inadequate responders to methotrexate, inadequate responders to conventional disease-modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Four of these five pivotal studies are expected to be completed by the end of 2015. Patients completing any of the five Phase 3 studies can enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.


Source: Incyte Corporation and Eli Lilly and Company