Incyte won a $50 million milestone payment from Eli Lilly tied to formal initiation of the rheumatoid arthritis (RA) Phase III program for baricitinib, Incyte’s oral JAK1/JAK2 inhibitor (formerly INCB28050).

Incyte and Lilly disclosed the payment today, two days after the companies presented 24-week results from a Phase IIb study of baricitinib in patients with moderate-to-severe RA who had an inadequate response to treatment with methotrexate.

At the annual meeting of the American College of Rheumatology in Washington, D.C., the companies released data showing that compared with patients taking placebo, patients taking baricitinib 4 mg or 8 mg once daily reported significant differences in ACR20, ACR50, and ACR70 responses—meaning at least 20%, 50%, or 70% improvement in both the tender joint count and swollen joint count, and in at least three of five other core set measures.

The best response was in patients in the 4 mg dosage; 78% of all enrolled patients reached ACR20, followed by 73% reaching ACR20 in the 8 mg dosage. The least response was seen in the 10% of patients on the 2 mg dosage who attained ACR70.

“Patients experienced improvement with baricitinib as early as week 2 that was sustained through week 24,” said Mark Genovese, M.D., the James Raitt professor of medicine and co-chief, division of immunology and rheumatology at Stanford University School of Medicine, and steering committee member for the study. “The percentage of patients achieving ACR50 and ACR70 increased over time and no unexpected safety findings emerged with continued dosing.”

The study also included a large sub-study of 154 patients using magnetic resonance imaging to examine the effect of different doses of baricitinib on joint changes in a subgroup of patients with erosive RA and inadequate response to treatment with methotrexate.

Through 24 weeks, patients saw statistically significant improvement in both the Total Inflammation Score and the Total Joint Damage Score for both 4 mg and 8 mg baricitinib doses compared with placebo at 12 weeks.

For Phase III, plans call for four RA studies on the safety and efficacy of baricitinib 2 mg and 4 mg once daily in patients with active RA who are methotrexate-naive, biologic-naive, or biologic-experienced. Patients completing any of the four studies will be eligible for enrollment in a fifth study, a long-term extension.

Lilly is conducting the Phase III program as part of the exclusive worldwide License, Development and Commercialization Agreement for baricitinib both companies entered into in December 2009. At the time, Incyte received a $90 million up-front payment from Lilly, with eligibility for up to $665 million tied to development, regulatory, and commercialization milestones, as well as tiered, double-digit royalty payments on future global sales with rates ranging up to 20% if a product is successfully commercialized.

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