Dermira Announces Initiation of Phase 3 Program Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis

Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced dosing of the first patient in a Phase 3 study evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis, the most common form of eczema.

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.

“The positive results of our Phase 2b dose-ranging study suggest specifically targeting IL-13 with lebrikizumab has the potential to deliver a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis,” said Tom Wiggans, chairman and chief executive officer of Dermira. “Our Phase 3 clinical program is designed to confirm those findings and hopefully bring an important new treatment option to the millions of people living with this chronic and often debilitating disease. We expect to report findings from the 16-week induction period of the monotherapy studies in the first half of 2021.”

“The initiation of the Phase 3 study combined with the positive results of the Phase 2b study underscore our confidence and excitement around the potential of lebrikizumab for patients with moderate-to-severe atopic dermatitis,” said Peter Guenter, chief executive officer of Almirall, Dermira’s collaboration partner in Europe. “Almirall is fully committed to this partnership and to offering breakthrough treatments, like lebrikizumab, that have the potential to make a meaningful difference for patients living with severe skin conditions.”

Lebrikizumab Phase 3 Program

The lebrikizumab Phase 3 program includes two identical, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies designed to confirm the safety and efficacy of lebrikizumab as monotherapy in patients with moderate-to-severe atopic dermatitis. The studies are expected to enroll a total of approximately 800 adult and adolescent patients ages 12 years and older with moderate-to-severe atopic dermatitis at approximately 200 sites in the United States, Europe and Asia.