Eli Lilly and Company LLY and partner Incyte’s INCY oral JAK inhibitor, Olumiant (baricitinib) met the primary endpoint in a phase III study evaluating it as a monotherapy in moderate-to-severe atopic dermatitis (“AD”), a type of eczema.
Top-line data from the BREEZE-AD5 study showed that 16-week treatment with 2mg dose of Olumiant met the primary endpoint of at least 75% improvement in skin inflammation, measured by Eczema Area and Severity Index (“EASI”), from baseline. BREEZE-AD5, conducted in North America, evaluated 1-mg and 2-mg doses of Olumiant as a monotherapy in AD patients.
The higher dose of the drug also met a key secondary endpoint of another measure of skin inflammation defined by clear or almost clear skin and at least 2 points improvement in the validated Investigator's Global Assessment for AD. This marks the fifth successful completion of a late-stage study evaluating Olumiant in AD patients.
Detailed data from the study will be presented at future scientific conferences and published in peer-reviewed journals. Lilly has already submitted a regulatory application seeking approval for label expansion of Olumiant to treat AD patients in Europe. Data from the BREEZE-AD5 study will support a supplemental new drug application or sNDA submission to the FDA for a similar label expansion of the drug.
The company previously completed successfully four phase III AD studies – BREEZE-AD1, BREEZE-AD2, BREEZE-AD4 and BREEZE-AD7. While 2mg and 4mg dosages of Olumiant met the primary endpoint of BREEZE-AD1 and BREEZE-AD2 studies, only 4mg dose of the drug met the primary endpoint in BREEZE-AD7 study. Earlier this week, the company reported data from BREEZE-AD4 study that demonstrated 4mg of Olumiant plus topical corticosteroids achieved at least 75% improvement in EASI from baseline after 16 weeks of treatment.
In the past year, shares of Lilly have gained 19% compared with the industry's increase of 12.4%.
Olumiant is one of the drugs in Lilly’s new pharmaceutical product portfolio, which is anticipated to be a key top-line driver going ahead. The drug generated $426.9 million in 2019, up more than 110% year over year mainly driven by upbeat sales in Europe.
Lilly is also developing Olumiant as a treatment for systemic lupus erythematosus and alopecia areata in mid-to-late stage studies.
Meanwhile, competition is on the rise in the JAK inhibitor segment as well as the eczema market. Regeneron Pharmaceuticals and Sanofi’s Dupixent is approved for treating AD since 2017 while AbbVie ABBV and Pfizer PFE are developing their respective candidates for the indication in late-stage studies.
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Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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