Efficacy results for an experimental rheumatoid arthritis drug in development by Eli Lilly ($LLY) and Incyte ($INCY) held up well as patients in a Phase IIb trial were tracked over the course of a full year.
After 52 weeks of treatment with baricitinib, the group of patients reporting a 20% improvement in RA symptoms slipped slightly to 71%, down a bit from the 74% recorded at 24 weeks. But the group reporting a 50% improvement in symptoms swelled a bit, growing from 41% to 49%, while the 70%-improvement group jumped from 21% to 27%.
That's good news for the developers, who pivoted into Phase III on positive 24-week results for baricitinib, an oral JAK1/JAK2 inhibitor that's in a pack of new oral drugs looking to compete with injected therapies. (It's also in mid-stage studies for psoriasis and diabetic nephropathy.) Pfizer's ($PFE) Xeljanz led the way with the first FDA approval for an oral RA drug, another JAK inhibitor which is now competing with blockbuster biologics like Humira and Enbrel. But the Europeans failed to follow suit with a green light on the continent, turning their thumbs down on the treatment. And AstraZeneca ($AZN) had to toss in the towel recently on the oral fostamatinib after failing to beat out Humira in a head-to-head.
This is an important treatment for Eli Lilly, which has been repeatedly frustrated in recent years by a litany of clinical trial failures, including the late-stage bomb for the Alzheimer's drug solanezumab. Lilly paid $90 million upfront and promised $665 million in milestones to partner with Incyte back in 2009. And now it's one of about a dozen late-stage programs that will either justify CEO John Lechleiter's faith in the pharma giant's big R&D arm--now committed to two new drug approvals a year beginning in 2013--or help force a revamp of its strategy.
"In this clinical trial baricitinib showed statistically and clinically significant improvements in the features of this condition, which were maintained throughout a year of treatment. To date, baricitinib has demonstrated an acceptable safety profile and side effects have generally been straightforward to manage," said Peter Taylor of University of Oxford, a member of the steering committee for the study.
- here's the press release
Special Report: Eli Lilly - Biopharma's Top R&D Spenders - 2012