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Lilly (LLY) and Dermira Present New Lebrikizumab Phase 2b Clinical Data Showing Patients with Atopic Dermatitis Had Clinically Meaningful Improvements in Itch, Sleep and Quality of Life

June 12, 2020 3:47 PM

Eli Lilly and Company (NYSE: LLY) and Dermira, Inc., a wholly-owned subsidiary of Eli Lilly and Company, presented new data from the Phase 2b clinical trial of lebrikizumab in patients with moderate-to-severe atopic dermatitis. Data from this study suggests that treatment with lebrikizumab provided rapid and clinically meaningful improvements in itch, sleep and overall measures of quality of life.

Emma Guttman-Yassky, M.D., Ph.D., a leading investigator, presented the results of the data analysis during a virtual late-breaking, oral session at the American Academy of Dermatology (AAD) 2020 Annual Meeting.

"Understanding the potential for lebrikizumab to improve the skin symptoms of atopic dermatitis as well as other commonly associated symptoms, such as itch and loss of sleep, is critical to understanding its true potential to help patients," said Guttman-Yassky, the Sol and Clara Kest professor of dermatology, vice chair of the department of dermatology, director of the Center for Excellence in Eczema and director of the laboratory of inflammatory skin diseases in the department of dermatology at Icahn School of Medicine at Mount Sinai. "These results suggest that lebrikizumab could provide clinically meaningful improvement in treating symptoms that are most bothersome to patients."

The results of the data analysis showed that lebrikizumab improved symptoms and quality of life in a rapid, dose-dependent manner across a range of atopic dermatitis-specific and other measures compared with placebo. Specifically, lebrikizumab improved:

"These data help us understand how the treatment may work for patients to alleviate symptoms such as itch and sleep which are known to severely impact the lives of the millions of patients living with atopic dermatitis," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We are currently evaluating lebrikizumab in a broad Phase 3 clinical program and look forward to further progressing this important investigational medicine given the clear need for additional options for patients living with this debilitating condition."

"Itch is a debilitating symptom for people living with atopic dermatitis, and it affects the physical, mental, emotional, social and financial areas in their lives," said Lisa Butler, senior vice president, strategic partnerships and programs at the National Eczema Association. "The burden on patients and families is still widely underappreciated, so it is encouraging to see new therapies in development that could potentially address the symptoms that this community struggles with the most on a daily basis."

In the randomized, double-blind, placebo-controlled, Phase 2b dose-ranging study, 280 patients with moderate-to-severe atopic dermatitis were randomized 3:3:3:2 to one of three doses of subcutaneous lebrikizumab (125 mg every four weeks, 250 mg every four weeks, or 250 mg every two weeks) or placebo every two weeks for 16 weeks with safety follow-up to Week 32. The primary endpoint was the percent change in Eczema Area Severity Index (EASI) from baseline at Week 16. Secondary endpoints measured atopic dermatitis severity, itch, sleep loss, and included the proportions of patients achieving EASI50, EASI75, EASI90, a score of 0 or 1 on the Investigator's Global Assessment (IGA), and a >4-point improvement on the pruritus (itch) 11-point numeric rating scale (NRS) assessing daily itch. Change in sleep loss from baseline also was measured.

Lebrikizumab was generally well-tolerated. The safety profile was consistent with previous studies, including low frequency of conjunctivitis, herpes virus infections and injection site reactions.

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