Eli Lilly (LLY), Incyte (INCY) Achieve Primary Endpoint in Baricitinib Phase IIb as JAK Inhibitor
Tweet Send to a FriendGet Alerts LLY Hot Sheet
Price: $54.14 -1.1%
Overall Analyst Rating:
NEUTRAL (
Down)
Dividend Yield: 3.5%
Revenue Growth %: 0.0%
Overall Analyst Rating:
NEUTRAL (
Down)Dividend Yield: 3.5%
Revenue Growth %: 0.0%
Trade LLY Now!
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) announced the presentation of 12-week results from a Phase IIb study of baricitinib, formerly LY3009104 (INCB28050), an orally available janus kinase (JAK) inhibitor, in patients with active rheumatoid arthritis (RA). The results were presented as a late-breaking oral presentation at the European League Against Rheumatism's (EULAR) Annual European Congress of Rheumatology [EULAR abstract LB0005: 12-Week Results of a Phase IIb Dose-Ranging Study of LY3009104 (INCB028050), an Oral JAK1/JAK2 Inhibitor, in Combination with Traditional DMARDs in Patients with Rheumatoid Arthritis].
The Phase IIb randomized double-blind, placebo-controlled, dose-ranging study, known as JADA, involved a total of 301 patients with active RA on stable doses of methotrexate. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks.
The Phase IIb trial achieved the primary endpoint by demonstrating a statistically significant difference in the American College of Rheumatology 20 (ACR20) response between the combined 4 mg and 8 mg baricitinib groups (76 percent) compared with placebo (41 percent) after 12 weeks of treatment (p<0.001). Statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.
A statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups compared with placebo.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
The Phase IIb randomized double-blind, placebo-controlled, dose-ranging study, known as JADA, involved a total of 301 patients with active RA on stable doses of methotrexate. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks.
The Phase IIb trial achieved the primary endpoint by demonstrating a statistically significant difference in the American College of Rheumatology 20 (ACR20) response between the combined 4 mg and 8 mg baricitinib groups (76 percent) compared with placebo (41 percent) after 12 weeks of treatment (p<0.001). Statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.
A statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups compared with placebo.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Merck (MRK) Says Efficacy Not Achieved in Preladenant Phase 3s; Will Discontinue
- Universal Insurance (UVE) Completes 6.67M in Buybacks
- Tessera (TSRA), Starboard Reach Agreement Over Board Composition
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
