Eli Lilly and Company and Incyte Corporation have announced that five abstracts featuring data from three clinical studies and separate pharmacology studies for its investigational rheumatoid arthritis drug baricitinib will be presented at the 2015 annual meeting of the European League Against Rheumatism in Rome June 10-13. Lilly and Incyte previously released positive topline results for the RA-BEACON and RA-BUILD studies, both of which met their primary endpoint of ACR20 at 12 weeks as compared to placebo.
"Incyte is committed to translating R&D excellence into new medicines, and we are very pleased with the initial results from the Phase 3 trials program of baricitinib," said Rich Levy, M.D., chief drug development officer at Incyte Corporation.
"With the prevalence of rheumatoid arthritis worldwide, Lilly is excited to share further information about baricitinib with the scientific community,"said David Ricks, Lilly senior vice president, and president of Lilly Bio-Medicines. "Lilly remains committed to following the science to challenge convention and continuously improve outcomes."
Abstracts being presented are highlighted below or can be accessed on the EULAR website at http://www.congress.eular.org/.
"Baricitinib, An Oral Janus Kinase (JAK)1/JAK2 Inhibitor, In Patients With Active Rheumatoid Arthritis (RA) And An Inadequate Response To TNF Inhibitors: Results Of The Phase 3 RA-BEACON Study" - M. Genovese
"Baricitinib, an Oral JAK1/JAK2 Inhibitor, in Patients With Active Rheumatoid Arthritis and an Inadequate Response to cDMARDs: Results of the Phase 3 RA-BUILD Study" - M. Dougados
"Effects Of Baricitinib On Multi Biomarker Disease Activity Scores And Their Components In A Phase 2b Study In Moderate-To-Severe Rheumatoid Arthritis Patients" - P. Taylor
"Effects Of Baricitinib, An Oral JAK1/JAK2 Inhibitor, On Patient-Reported Outcomes From A Phase 3 Study In Patients Who Have Had An Inadequate Response To Tumor Necrosis Factor Inhibitors" - J.S. Smolen
"Evaluation Of Potential Drug-Drug Interactions With Baricitinib" - C. Payne
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 Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune diseasei characterized by inflammation and progressive destruction of joints.ii More than 23 million people worldwide suffer from RA.iii Approximately three times as many women as men have the disease. Patients and physicians indicate there remains an important opportunity to improve patient care. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral disease-modifying anti-rheumatic drugs such as methotrexate, and injectable biological response modifiers that target selected mediators implicated in the pathogenesis of RA.iv
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 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 http://www.clinicaltrials.gov.