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Lilly (LLY) Phase III Eczema Study on Lebrikizumab Meets Goal

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Eli Lilly & Company (LLY - Free Report) announced data from two pivotal phase III studies, which showed that its investigational IL-13 inhibitor, lebrikizumab significantly improved skin clearance and itch in patients with moderate-to-severe atopic dermatitis (“AD”), also called eczema.

The phase III ADvocate 1 and ADvocate 2 studies met the primary and all key secondary endpoints, including skin clearance and itch improvement, at Week 16.

The top-line data from the two studies showed that more than half the patients treated with lebrikizumab, as a monotherapy, experienced at least 75% skin clearance as measured by Eczema Area and Severity Index (EASI) score. Full data from the two studies will be presented at a future medical meeting.

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. The candidate is also being evaluated in a phase III combination study (ADhere) with topical corticosteroids in AD, data from which is expected to be available later this year.

Lilly’s stock has risen 59.8% this year so far compared with an increase of 17.2% for the industry.

 

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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.

In a separate press release, Lilly announced that the FDA has approved a new delivery option for Lyumjev, its new rapid-acting insulin. Lyumjev 100 units/mL has been approved for use in an insulin pump to improve glycemic control in adults with type I and II diabetes. Lyumjev, a new fast-acting formulation of Lilly’s insulin lispro (Humalog), was approved by the FDA in June last year.

Zacks Rank and Stocks to Consider

Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

Some better-ranked stocks from the biotech sector include Horizon Therapeutics , Regeneron (REGN - Free Report) and Repligen Corporation (RGEN - Free Report) , all with a Zacks Rank #1.

Horizon Therapeutics’ earnings estimates have increased from $3.62 to $4.46 per share for 2021 and from $5.34 to $5.84 per share for 2022 in the past 30 days. The stock has risen 45.3% so far this year.

Regeneron’s earnings per share estimates have moved north from $49.53 to $54.15 for 2021 and from $41.35 to $44.11 for 2022 in the past 30 days. The stock has risen 30.2% so far this year.

Repligen’s earnings per share estimates have risen from $2.26 to $2.76 for 2021 and from $2.56 to $3.02 for 2022 in the past 30 days. The stock has risen 33.6% so far this year.


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