2:26 PM
Jun 13, 2018
 |  BC Extra  |  Clinical News

Lilly planning Phase III trials for Olumiant in lupus

Eli Lilly and Co. (NYSE:LLY) said it plans to start this year Phase III testing of Olumiant baricitinib to treat systemic lupus erythematosus (SLE) after reporting that the higher dose of the drug met the primary endpoint in a Phase II trial in the indication. Lilly presented the data at the European League Against Rheumatology meeting in Amsterdam.

Olumiant, a Janus kinase-1 (JAK-1) and JAK-2 inhibitor, is approved in over 40 countries to treat moderately to severely active rheumatoid arthritis (see BioCentury Extra, June 1).

The double-blind, international Phase II trial enrolled 314 patients with SLE who were receiving stable background therapy to receive placebo or once-daily 2 or 4 mg oral Olumiant for 24 weeks.

On the primary endpoint, a significantly greater proportion of patients who received high-dose Olumiant achieved resolution of arthritis or rash as defined by SLE Disease Activity-2K (SLEDAI-2K) score at week 24 vs. placebo (67.3% vs. 53.3%, p≤0.05). High-dose Olumiant also met the secondary endpoint of improving SLE Responder Index (SRI)-4 response rate at week 24 vs. placebo (64.4% vs. 47.6%, p≤0.05). The 2 mg dose of Olumiant missed both endpoints (58.1% for SLEDAI-2K and 51.4% for SRI-4).

A Lilly spokesperson told BioCentury the company will evaluate both doses of Olumiant in Phase III trials to treat SLE.

Lilly and Incyte Corp. (NASDAQ:INCY) share rights to Olumiant under a 2009 deal.

Incyte was off $0.04 to $70.54 on Wednesday.

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