Almirall: Eight out of Ten Patients Maintained Skin Clearance at One Year in Lebrikizumab Atopic Dermatitis Monotherapy Trials

• 80% of lebrikizumab responders maintained improvements in skin clearance and disease severity at 52 weeks; lasting improvements in itch were also observed
• Data supported both once every two week and once every four week maintenance dosing, with consistent and durable responses

BARCELONA, Spain, June 7, 2022 /PRNewswire/ -- Almirall S.A. (BME: ALM) today announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, an investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period. These results build upon positive data from the 16-week, double-blind, placebo-controlled part of the ADvocate program. 

"We are pleased to witness how lebrikizumab has proven over a year its potential to be a leading option for the treatment of atopic dermatitis. 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," stated Karl Ziegelbauer, Ph.D., Almirall's Chief Scientific Officer. 

AD, or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.^1-2 Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin-13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway.^3-7 IL-13 plays the central role in AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.^8-10

In ADvocate 1, 79% of patients who received lebrikizumab every four weeks and 79% of patients who received lebrikizumab every two weeks maintained 75% or greater skin improvement (EASI-75) at one year of treatment. Additionally, 85% of patients who received lebrikizumab every four weeks and 77% of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 at one year of treatment. 

The frequency of adverse events and the overall safety profile among these patients treated with lebrikizumab were consistent with the induction phase of the trials as well as previous lebrikizumab studies in AD. No new safety signals were observed in this patient population. 

"In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at one year. We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Eli Lilly and Company.

With these data, Almirall plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lebrikizumab in AD in the second half of 2022. Lilly also plans to submit an application to the U.S. Food and Drug Administration (FDA) this year, followed by submissions to other regulatory agencies around the world.

These studies are part of the comprehensive clinical development program for lebrikizumab in AD evaluating more than 2,000 patients. Full one-year results from the Phase 3 monotherapy studies will be disclosed at upcoming congresses and in publications in 2022. Additional Phase 3 clinical trials are enrolling for lebrikizumab in AD.

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

*EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16

About ADvocate 1 and ADvocate 2 and the Phase 3 Program

ADvocate 1 and ADvocate 2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD. During the 16-week treatment period, patients received lebrikizumab 500-mg initially and at two weeks, followed by lebrikizumab 250-mg or placebo every two weeks. In the maintenance period, patients with moderate-to-severe AD who achieved a clinical response after 16 weeks of lebrikizumab treatment were re-randomized to receive lebrikizumab every two weeks or every four weeks or placebo for an additional 36 weeks. Patients who required rescue treatment during the induction period or who did not achieve clinical response (lebrikizumab non-responders) at 16 weeks received lebrikizumab every two weeks for an additional 36 weeks. The primary endpoints were measured by an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least 75 percent change in baseline in the Eczema Area and Severity Index (EASI-75) score at 16 weeks. EASI measures extent and severity of the disease. Key secondary endpoints were measured by IGA, EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus and the Dermatology Life Quality Index. 

The U.S. Food and Drug Administration (FDA) granted lebrikizumab Fast Track designation in AD in December 2019. The lebrikizumab Phase 3 program consists of five key global studies including two monotherapy studies, a combination study (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies.

About Lebrikizumab

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity to specifically prevent 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 the central pathogenic mediator of AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.^6-8

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient's needs through science to improve their lives.  Our Noble Purpose is at the core of our work: "Transform the patients' world by helping them realize their hopes and dreams for a healthy life". We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com 

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This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

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⁷ Okragly A, et al. Comparison of the Affinity and in vitro Activity of Lebrikizumab, Tralokinumab, and Cendakimab. Presented at the Inflammatory Skin Disease Summit, New York, November 3-6, 2021.
⁸ Tsoi L, et al. Journal of Investigative Dermatology. 2019;139(7):1480-1489.
⁹ Ratnarajah K, et al. Journal of Cutaneous Medicine and Surgery. 2021;25(3):315-328.
¹⁰ Bieber T. Allergy. 2020;75(1):54-62.

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