Lilly's (LLY) Eczema Study on Lebrikizumab Combo Meets Goal
Eli Lilly's (LLY) pivotal phase III study on lebrikizumab in combination with topical corticosteroids meets the primary and key secondary endpoints.
Eli Lilly & Company LLY announced data from the third pivotal phase III study — ADhere — evaluating its investigational IL-13 inhibitor, lebrikizumab, in combination with topical corticosteroids as a treatment for moderate-to-severe atopic dermatitis (“AD”) or eczema. The study met all primary and secondary endpoints at week 16
The study evaluated the candidate in AD patients for a score of clear or almost clear skin or improvement of two points from baseline on the Investigator Global Assessment scale and at least a 75% change from baseline on the Eczema Area and Severity Index (EASI) score at week 16 as its primary endpoints.
In the study, lebrikizumab significantly improved skin clearance and itch when combined with topical corticosteroids in the above patient group.
In August, Lilly had announced positive data from two pivotal studies — ADvocate 1 and ADvocate 2 — evaluating lebrikizumab as a monotherapy for treating moderate-to-severe AD. Data from the studies showed that treatment with lebrikizumab significantly improved skin clearance and itch in patients at week 16 following initiation of treatment.
However, both these studies are ongoing and will evaluate lebrikizumab monotherapy for a total of 52 weeks. Final data from these studies are expected in the first half of 2022.
Data from the three pivotal studies provide evidence that treatment with either lebrikizumab as monotherapy or in combination with topical corticosteroids has the potential to address unmet needs and improve care for people living with persistent itch and inflamed skin caused by AD.
Lilly plans to begin regulatory submissions in different countries including the United States and Europe next year following the completion of the ADvocate 1 and ADvocate 2 studies.
Lilly’s stock has risen 57.1% this year so far compared with an increase of 18.8% for the industry.
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Lebrikizumab was added to Lilly’s portfolio with the acquisition of Dermira in February 2020. The FDA had earlier granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients.
Lebrikizumab is part of Lilly’s immunology pipeline, which also includes candidates like mirikizumab, being studied in late-stage studies for ulcerative colitis and Crohn's disease. Key marketed drugs in Lilly’s immunology portfolio include Taltz and Olumiant.
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the pharma/biotech sector include GlaxoSmithKline GSK, Repligen RGEN and Sarepta Therapeutics SRPT. While Repligen sports a Zacks Rank #1 (Strong Buy), Glaxo and Sarepta carry a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings per share estimates for Glaxo have increased from $2.81 to $3.05 for 2021 and from $3.06 to $3.25 for 2022 in the past 60 days.
Glaxo delivered an earnings surprise of 15.28%, on average, in the last four quarters. GSK’s shares are up 18.4% so far this year.
Earnings per share estimates for Repligen have moved north from $2.76 to $2.90 for 2021 and from $3.03 to $3.21 for 2022 in the past 60 days.
Repligen delivered an earnings surprise of 49.21%, on average, in the last four quarters. RGEN’s shares are up 39.6% so far this year.
Estimates for 2021 have narrowed from a loss of $6.95 to $4.99 for Sarepta in the past 60 days. Estimates for Sarepta’s 2022 bottom line have changed from a loss per share of $4.83 to earnings per share of $3.61 in the past 60 days.
Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
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