Lilly: Lebrikizumab Meets Primary, Secondary Goals In ADvocate 1, ADvocate 2 Phase 3 Trials

Drug major Eli Lilly And Co. (LLY) announced Monday that lebrikizumab ADvocate 1 and ADvocate 2 Phase 3 clinical trials met primary and all key secondary endpoints at Week 16. Lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis or AD in the two Phase 3 trials.

Lebrikizumab as a monotherapy in AD led to significant improvements with at least 75 percent skin clearance in more than half of people with moderate-to-severe AD.

Lebrikizumab is a novel monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling.

The U.S. Food and Drug Administration or FDA has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients.

AD, also known as atopic eczema, is a chronic inflammatory skin disorder caused by skin barrier dysfunction and dysregulation of the immune response.

ADvocate 1 and ADvocate 2 are ongoing 52-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe AD.

The company noted that the primary efficacy endpoints were assessed at 16 weeks in the two studies. Lebrikizumab also achieved key secondary endpoints versus placebo in patients with AD, including early onset in skin clearance and itch relief, improvement in interference of itch on sleep and quality of life.

The company will disclose the full study results from ADvocate 1 and ADvocate 2 at future congresses in 2022. Data from a Phase 3 combination study (ADhere) of lebrikizumab with topical corticosteroids in patients with AD will be available later this year.

These studies are part of the lebrikizumab Phase 3 program, which consists of five key ongoing, global studies.

Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and rest of world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

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