Key insights
- Eli Lilly's drug Ebglyss demonstrated efficacy in a Phase 3b trial for moderate-to-severe hand and foot atopic dermatitis, meeting primary and secondary endpoints. The study showed significant improvements in skin clearance, itch relief, and pain reduction compared to placebo. Lilly plans to submit this data to regulatory authorities for a potential label update, which could expand the drug's approved indications.
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced today that its drug Ebglyss met primary and secondary endpoints in a Phase 3b clinical trial for patients with moderate-to-severe hand and foot atopic dermatitis, according to a press release statement.
The ADtouch study evaluated 221 adults and adolescents who received either Ebglyss or placebo every two weeks for 16 weeks. At Week 16, 53% of patients treated with Ebglyss achieved clear or almost clear skin on hands and feet, compared to 27% on placebo. The study enrolled patients with inadequate response to topical therapies.
Regarding itch relief, 57% of Ebglyss-treated patients showed significant improvement at Week 16 versus 19% on placebo. For pain relief, 59% of Ebglyss patients demonstrated significant improvement compared to 19% receiving placebo.
In patient satisfaction measures, 77% of Ebglyss-treated patients reported being satisfied or very satisfied with hand clearance at Week 16, compared to 40% on placebo. Treatment-emergent adverse events occurred in 41.8% of Ebglyss patients and 39.6% of placebo patients, with all events classified as mild or moderate. The most common adverse reactions were nasopharyngitis and upper respiratory tract infection.
Lilly submitted the data to the U.S. Food and Drug Administration and plans submissions to select global regulatory authorities for a potential label update.
Ebglyss, an interleukin-13 inhibitor, is currently approved in the U.S. for adults and children 12 years and older weighing at least 88 pounds with moderate-to-severe atopic dermatitis not well controlled by topical therapies. The drug received U.S. approval in 2024 for maintenance dosing every four or eight weeks.
Lilly holds exclusive development and commercialization rights for Ebglyss in the U.S. and outside Europe, while Almirall licensed rights for European dermatology indications.
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