Lilly’s Ebglyss meets endpoints in pediatric dermatitis trial

INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced today that its atopic dermatitis treatment Ebglyss met primary and key secondary endpoints in a Phase 3 trial studying pediatric patients aged six months to 18 years with moderate-to-severe disease. The positive results come as the $880 billion pharmaceutical giant continues its strong revenue trajectory, posting 45% revenue growth over the last twelve months.

In the ADorable-1 study, 63% of patients achieved a 75% reduction in disease severity (EASI-75) and 44% achieved clear or almost clear skin at Week 16, compared to 22% and 15% for placebo, respectively, according to a press release statement. The trial enrolled 363 participants who received either placebo or weight-based doses of Ebglyss alongside required topical corticosteroids.

Among key secondary endpoints, 39% of patients achieved a 90% reduction in disease severity versus 11% for placebo. In patients six years and older with baseline itch scores of at least 4, 35% experienced significant itch relief compared to 6% for placebo.

The safety profile was consistent with adult and adolescent studies, with no new safety signals observed. The most common adverse events were upper respiratory tract infections and nasopharyngitis, occurring in at least 5% of participants with no numerical imbalance between groups. No injection site pain was reported.

Ebglyss is an interleukin-13 inhibitor that selectively blocks IL-13 signaling. The cytokine IL-13 drives type-2 inflammatory processes in atopic dermatitis, leading to skin barrier dysfunction and itch.

Lilly plans to submit the data to U.S. and global regulators for a potential label update. Ebglyss is currently approved in the U.S., Japan and Canada for adults and children 12 years and older weighing at least 88 pounds with moderate-to-severe atopic dermatitis.

The ADorable clinical program continues with ADorable-2, a 52-week extension study. Additional results from both studies will be disclosed later this year.

Lilly holds exclusive development and commercialization rights for Ebglyss in the U.S. and outside Europe, while partner Almirall holds rights for European dermatology indications.

In other recent news, Eli Lilly announced plans to invest $3 billion in China over the next decade to expand production capacity for orforglipron, an experimental treatment for type-2 diabetes and obesity. The company has submitted a marketing application for orforglipron to China’s drug regulator, aiming for future approval. Meanwhile, Jefferies has reiterated a Buy rating on Eli Lilly stock, maintaining a price target of $1,300. This decision follows prescription data showing growth in GLP-1 medications, including Wegovy and Zepbound. Bernstein also reaffirmed an Outperform rating for Eli Lilly, noting updates to GLP-1 distribution channels in the U.S., with significant Medicaid and Medicare expansions planned in the coming years.

Morgan Stanley reported that supply constraints, rather than reduced demand, have caused a slowdown in Mounjaro sales in Brazil, though a rebound in imports could indicate a potential recovery. Deutsche Bank echoed a positive outlook by reiterating a Buy rating and a $1,285 price target, highlighting a 7% week-over-week increase in GLP-1 prescriptions. These developments underscore Eli Lilly’s strategic focus on expanding its GLP-1 drug offerings and addressing supply issues to meet growing demand.

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