Almirall: The New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD) publish Ph3 data evaluating lebrikizumab efficacy and safety in moderate-to-severe atopic dermatitis

Almirall recently announced the publication of Week 16 and Week 52 results of ADvocate1 and ADvocate2 by the New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD), respectively. ADvocate1 and ADvocate2 are two identical 52-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies (NCT04146363 and NCT04178967), evaluating lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis. 

“AD is a debilitating chronic disease that requires effective treatment options that, in addition to achieving skin clearance and control of symptoms, can improve the quality of life of those patients who suffer it. The encouraging data from the ADvocate trials give us confidence that lebrikizumab, which acts directly on the IL-13 key cytokine, may offer a new treatment option for moderate-to-severe AD, once approved,” said Prof. Dr. med. Diamant Thaçi, Director at the Comprehensive Centre for Inflammation Medicine at the University of Lübeck in Germany, and principal investigator of the ADvocate 2 trial.

“We are delighted by the publication of the Phase 3 data in the NEJM and BJD respectively, highly regarded and rigorously peer-reviewed journals. The published clinical trial data support the positive results we have reported previously on the potential efficacy of lebrikizumab in moderate-to-severe AD and underscore our commitment to people living with AD,” said Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer. “Awaiting approval in Europe later this year, we are still working toward the market launch of this treatment, convinced of its potential to become a best-in-class treatment for atopic dermatitis,” he added.

These two publications in the NEJM and BJD add to the recent recognitions of lebrikizumab's value by the scientific community. Recently, the peer-reviewed medical journal JAMA Dermatology  published the results of the Phase 3 clinical trial Adhere (ClinicalTrials.gov Identifier: NCT04250337) evaluating the efficacy and safety of lebrikizumab in combination with topical corticosteroid (TCS) therapy in adolescents and adults with moderate-to-severe AD. In this randomized Phase 3 clinical trial, lebrikizumab in combination with TCS was associated with improved outcomes compared with TCS alone, and safety was consistent with previously reported AD trials.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world, not including Europe.