INCY Incyte Corporation

By Chris Wack

Eli Lilly & Co. (LLY) and Incyte Corp. (INCY) said Monday that baricitinib met the primary endpoint in the Breeze-AD4 investigational phase 3 study.

The companies said they evaluated the safety and efficacy of baricitinib in combination with topical corticosteroids for the treatment of adult patients with moderate to severe atopic dermatitis who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine.

The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index at week 16.

The study evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib, and the 4-mg dose of baricitinib plus topical corticosteroids met the primary endpoint as defined by the proportion of participants achieving Eczema Area and Severity Index at week 16.

The companies said the safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis. The most common treatment-emergent adverse events included nasopharyngitis, headache, and influenza. No venous thromboembolic events or deaths were reported in the trial.

Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020.

Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as Olumiant.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 27, 2020 07:16 ET (12:16 GMT)

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