Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic dermatitis (AD) who had previously been treated with dupilumab.
The primary endpoint of the study, measured by at least a 75 percent improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks, showed that 57 percent of patients achieved EASI-75 at Week 16, and 60 percent at Week 24, who had prior exposure to dupilumab. These results are consistent with the Phase III monotherapy trials of Ebglyss in patients without prior dupilumab exposure, known as ADvocate 1 and ADvocate 2. Furthermore, 46 percent of patients who were inadequate responders to dupilumab achieved EASI-75 response with Ebglyss at Week 16.
Ebglyss, which is anticipated to offer similar or superior long-term efficacy when administered once every four months compared to dupilumab, received approval in the European Union in 2023 and in Japan in January 2024. It recently gained marketing approval in the United States last month as a first-line biologic treatment for adults and children aged 12 and older. Lilly holds exclusive rights for the development and commercialization of Ebglyss in the U.S. and the rest of the world outside Europe. Almirall S.A., Lilly’s partner, has licensed the rights to develop and commercialize Ebglyss for dermatology indications, including eczema, in Europe.- Flcube.com
