By Colin Kellaher

 

Eli Lilly & Co. and Incyte Corp. on Wednesday said a Phase 3 study evaluating the efficacy and safety of baricitinib met the key goal in the treatment of the autoimmune disorder alopecia areata.

The companies said both the two-milligram and four-milligram once-daily doses in adults with severe alopecia areata met the primary efficacy endpoint at week 36, showing a statistically significant improvement in scalp hair regrowth compared to those on placebo.

There are currently no FDA-approved treatments for alopecia areata, which can cause unpredictable hair loss on the scalp, face and other areas of the body.

Eli Lilly and Incyte said the study marks the first Phase 3 trial with positive results in patients with the disorder, adding that they expect data from an additional Phase 3 study in the first half of the year.

Indianapolis-based Eli Lilly signed an exclusive worldwide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize baricitinib and other compounds for inflammatory and autoimmune diseases.

The companies last March received breakthrough-therapy designation from the U.S. Food and Drug Administration for baricitinib for the treatment of alopecia areata.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

March 03, 2021 07:13 ET (12:13 GMT)

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