The Phase III ADvocate 1 and 2 studies on lebrikizumab showed that eight out of 10 patients with atopic dermatitis maintained skin clearance in the 12 months they had been under treatment.
Courtesy Susan Montgomery/Getty Images
One year after beginning clinical trials, Eli Lilly and Company’s announced its candidate drug for atopic dermatitis demonstrated significant safety and efficacy.
Topline data from the Phase III ADvocate 1 and 2 studies on the investigational IL-13 inhibitor lebrikizumab showed that eight out of ten patients living with moderate-to-severe atopic dermatitis maintained skin clearance in the 12 months they received treatment. Clinical response was measured using EASI-75 (Eczema Area Severity Index).
The patients received lebrikizumab either once every two or four weeks. In ADvocate 1, 79% of the participants who received the drug every two weeks and 79% of those who took it every four weeks maintained 75% or greater skin improvement at year one. In ADvocate 2, 77% of those who took the medication every two weeks and 85% of those who dosed every four weeks had maintained skin clearance over the same length of time.
Lebrikizumab is a novel, monoclonal antibody that binds to IL-13 to prevent the formation of the type 2 receptor IL-13Rα1/IL-4Rα. IL-13 plays a major role in promoting Type 2 inflammations that lead to skin dysfunctions such as itching, infection and thickening.
“Atopic dermatitis is a complex disease that requires personalized treatment approaches, including flexible dosing options for patients. In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch in one year. We believe this supports the potential of lebrikizumab to become a first-line biologic and may support less frequent dosing,” Dr. Lotus Mallbris, the vice president of global immunology development and medical affairs at Eli Lilly, commented in a statement.
These positive results will support Lilly as it files for a Biologics License Application with the U.S. Food and Drug Administration for atopic dermatitis by the second half of 2022. It will also be submitting applications to regulatory agencies worldwide, including the European Medicines Agency.
Lilly will exclusively develop and commercialize the drug in the U.S. and worldwide, except in Europe. In Europe, development and commercialization will be handled by Almirall to treat various skin concerns, AD included.
“ADvocate 1 and 2 results add to the exciting growing body of evidence from our Phase 3 clinical trial program and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options. We look forward to continuing our collaboration with Lilly and advancing in our clinical program, aiming to obtain approval in the European Union,” Dr. Karl Ziegelbauer, CSO of Almirall, noted in the same press release.
The FDA gave lebrikizumab a Fast Track Designation for atopic dermatitis in December 2019. Eli Lilly’s Phase III program for the drug is composed of five global trials, including two monotherapy studies (ADvocate 1 and ADvocate 2), a combination trial (ADhere), an adolescent open-label study (ADore) and a long-term extension (ADjoin).
