Eli Lilly, Incyte Corporation Arthritis Drug Meets Endpoint In Phase 3
Published: Dec 10, 2014
December 9, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Wilmington, Del.-based Incyte and Indianapolis-based Eli Lilly announced today positive results from its Phase 3 RA-BEACON study of baricitinib for the treatment of rheumatoid arthritis (RA). The drug met the trial’s primary endpoint of improved ACR20 response when compared to placebo 12 weeks after treatment.
“We are very pleased by these results,” said Rich Levy, Incyte’s chief drug development and medical officer in a statement. “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 study followed 527 people enrolled in the RA-BEACON trial. The participants had previously failed at least one anti-TNF therapy. As a result, many participants had received earlier treatment from one or more non-anti-TNF agents. In the study, patients received one or two doses of baricitinib or placebo daily, as well as their conventional background drug treatment (cDMARDs)
The study found that serious adverse events with baricitinib were similar to placebo. No opportunistic infections or GI perforations were observed. However, there was a higher rate of treatment-emergent adverse events with the drug compared to placebo. The most common were headache, upper respiratory tract infections and nasopharyngitis.
Baricitinib is a selective JAK1 and JAK2 inhibitor, taken orally. JAK-dependent cytokines are related to the pathogenesis of several inflammatory and autoimmune diseases. Baricitinib has shown about a 100-fold greater potency of inhibition against JAK1 and JAK2 than against JAK3 in assays. There are four JAK enzymes, JAK1, 2, 3 and 4.
The two companies entered into an exclusive worldwide license and collaborative agreement in December 2009 to develop and commercialize baricitinib. The compound is in Phase 3 trials for RA and Phase 2 for psoriasis and diabetic nephropathy.
“People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments,” said David Ricks, senior vice president and president of Lilly Bio-Medicines in a statement. “These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition.”
Analysts have projected that baricitinib could bring in $673 million in 2020. This would be good news for the company, whose patent for its blockbuster antidepressant Cymbalta expired last year. Cymbalta brought in $5.08 billion in 2013 and is projected to sell $1.6 billion this year.