Almirall: Lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study

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BARCELONA, Spain, Dec. 21, 2021

Study met all primary and key secondary endpoints
Safety profile consistent with prior lebrikizumab studies in atopic dermatitis
Global regulatory submissions to occur next year based on data from the Phase 3 clinical trial program

BARCELONA, Spain, Dec. 21, 2021 /PRNewswire/ -- Lebrikizumab, an IL-13 inhibitor, significantly improved disease severity when combined with topical corticosteroids (TCS) in people with moderate-to-severe atopic dermatitis (AD) in a third pivotal Phase 3 trial (ADhere) announced today by Almirall S.A. (BME: ALM). By Week 16, the study met all primary and key secondary endpoints for patients on the lebrikizumab combination arm.

Lebrikizumab is a novel, investigational monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling.^1-5 In people with AD, the IL-13 protein—a central pathogenic mediator in the disease—is overexpressed, driving multiple aspects of AD pathophysiology by promoting T-helper type 2 (Th2) cell inflammation and resulting in skin barrier dysfunction, itch, infection, flares and hard, thickened areas of skin.^6,7

"The signs and symptoms of AD differ depending on the individual patient characteristics and depending on the severity can affect their sleep, social activities, and their overall wellbeing. Patients need effective and well tolerated treatment options that can provide long term disease control and an optimal quality of life," said Dr. med. Andreas Pinter, Director of Clinical Research at the University Hospital in Frankfurt/Main (Germany) and one of the investigators of the ADhere trial. "Lebrikizumab recently showed its potential efficacy in monotherapy. Now, the data from ADhere also demonstrated its effect on skin clearance and itch relief as part of a combination therapy, suggesting the medicine could become a new treatment option for this immune-mediated chronic skin disease."

The primary endpoints were 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 a 75 percent change from baseline in their Eczema Area and Severity Index (EASI) score, both at Week 16. Lebrikizumab in combination with TCS also achieved all key secondary endpoints versus placebo in patients with AD, including skin improvement, itch relief, improvement in interference of itch on sleep, and quality of life. Key secondary endpoints were measured by EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus, and the Dermatology Life Quality Index.

Safety results in the 16-week placebo-controlled ADhere study were consistent with the 16-week period of the two monotherapy studies in the lebrikizumab Phase 3 program for AD. The most common adverse events (AEs) included conjunctivitis and headache for lebrikizumab-treated patients.

In August 2021, top-line data from ADvocate 1 and ADvocate 2 were announced by Almirall showing lebrikizumab as a monotherapy met primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life at Week 16.

"Once again, we are pleased with the robust data received thus far from lebrikizumab, both as monotherapy, as presented in the 16-week data readout from ADvocate 1 and 2 studies last August, or combined with corticosteroids, as shown in the results generated from the ADhere Phase 3 clinical trial announced today. These results validate the important role that IL-13 cytokine inhibitors play in AD treatment. The success of lebrikizumab in this study represents another key achievement in our journey to offer treatment advances in AD for patients and healthcare professionals who are seeking new options to cover the unmet need," stated Karl Ziegelbauer, Ph.D., Almirall S.A.'s Chief Scientific Officer.

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The detailed results from ADhere, along with data from two monotherapy Phase 3 trials, ADvocate 1 and ADvocate 2, are planned for future scientific congresses in 2022. Pending successful completion of the ongoing ADvocate 1 and ADvocate 2 monotherapy trials, Almirall and Eli Lilly and Company intend to begin EU, U.S. and other regulatory submissions next year.

"These results add to the growing body of evidence from our robust Phase 3 clinical trial program. We look forward to our continued partnership with Almirall to advance our global filing plans in the hopes of making lebrikizumab available to those who still have unmet needs," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and U.S. and global medical affairs at Lilly.

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 rest of world outside Europe.

About ADhere and the Phase 3 Program

ADhere is a 16-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of lebrikizumab in combination with TCS 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. In the study, patients' AD symptoms were inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI).

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 ongoing, global studies including two monotherapy studies and today's ADhere combination study as well as long-term extension (ADjoin) and adolescent open label (ADore) trials.

About Atopic Dermatitis

Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.⁸ AD is a heterogeneous disease both biologically and clinically and may be characterized by a highly variable appearance in which flares occur in an unpredictable manner.⁹

Moderate-to-severe AD is characterized by intense itching, which leads to an itch-scratch cycle that further damages the skin.¹⁰ Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.⁸ People living with AD often report symptoms of intense, persistent itch which can be so uncomfortable that it can affect sleep, daily activities and social relationships.

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 a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of AD by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.⁶

¹Moyle M, et al. Exp Dermatol. 2019;28(7):756-768.
²Ultsch M, et al. J Mol Biol. 2013;425(8):1330-1339.
³ Zhu R, et al. Pulm Pharmacol Ther. 2017;46:88-98.
⁴ Simpson EL, et al. J Am Acad Dermatol. 2018;78(5):863-871.e11.
⁵ 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.
⁶ Bieber T. Allergy. 2020;75(1):54-62.
⁷ Ungar B, et al. J Invest Dermatol. 2017;137(3):603-613.
⁸ Weidinger S, Novak N. Lancet. 2016;387:1109-1122.
⁹Langan SM, et al. Arch Dermatol. 2008;142:1109.
¹⁰ Yosipovitch G, et al. Curr Allergy Rep. 2008;8:306-311.

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