Almirall: Nearly 80% of patients with moderate-to-severe atopic dermatitis maintained clear or almost-clear skin with lebrikizumab monthly maintenance dosing at two years

43rd Annual Fall Clinical Dermatology Conference

Almirall S.A. (BME:ALM), a global biopharmaceutical company focused on medical dermatology, today announced results from the long-term extension study ADjoin which showed patients with moderate-to-severe atopic dermatitis who continued treatment with investigational lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing. Results from ADjoin will be presented at the 43rd Annual Fall Clinical Dermatology Conference happening from 19^th-22^nd October in Las Vegas, Nevada.¹

“These results from the ADjoin study provide new hope for patients with moderate-to-severe atopic dermatitis. The fact that the monthly maintenance dose of lebrikizumab can help nearly 80% of individuals maintain clear or almost clear skin for two years is truly promising. This breakthrough not only provides a potential long-term solution for patients, but also relief from the distressing symptoms they suffer from. It is a significant step forward in improving the lives and overall wellbeing of people living with this challenging disease despite the use of topical therapies,” said Prof. Dr. med. Diamant Thaçi, Prof. Dr. med. Diamant Thaçi, Director at the Institute and Comprehensive Centre for Inflammation Medicine, in Lübeck, Germany.

Lebrikizumab is an interleukin-13 (IL-13) inhibitor that specifically blocks IL-13 signaling.^2,3,4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.^5,6

ADjoin is the two-year extension of the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2 and ADhere, the combination trial with topical corticosteroids. Patients taking lebrikizumab who achieved IGA 0,1 or EASI-75 at 16 weeks in ADvocate 1 and 2 and ADhere were enrolled in ADjoin. Patients in the long-term extension trial received either lebrikizumab 250 mg every two weeks or monthly.¹

In ADjoin, lebrikizumab provided durable efficacy in skin and itch outcomes through two years of treatment with both monthly and two-week dosing.¹

Efficacy Outcomes of Patients Entering Long-Term Extension Trial ADjoin
Outcome, %	ADvocate 1&2 —> ADjoin		ADhere —> ADjoin
	Monthly (Q4W) LEBRI 250 mg (N=99)	Every two weeks (Q2W) LEBRI 250 mg (N=82)	Monthly (Q4W) LEBRI 250 mg (N=29)	Every two weeks (Q2W) LEBRI 250 mg (N=57)
IGA (0,1)	76	86	79	84
EASI 75	96​	96	96	95
EASI 90	83​	82	72	85
Pruritus NRS (Itch) ≥ 4-point improvement​	90​	100	90*	82*
* Data through 68 weeks for Pruritus NRS ≥4-point improvement for ADhere —> ADjoin study; data through 104 weeks for all other outcomes
EASI=Eczema Area and Severity Index; EASI 75=at least 75% improvement from baseline in EASI; EASI 90=at least 90% improvement from baseline in EASI; IGA=Investigator’s Global Assessment; IGA (0,1)=IGA response of clear or almost clear; NRS=numeric rating scale; Q2W=every 2 weeks; Q4W=every 4 weeks (monthly)

The safety profile of lebrikizumab in ADjoin was consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed up to two years of treatment. In ADjoin, 62 percent of patients reported adverse events (AEs), most of which were mild or moderate in severity. The most common side effects of lebrikizumab were conjunctivitis, injection site reactions and shingles (herpes zoster). Less than three percent of patients experienced AEs leading to treatment discontinuation.¹

“The two-year data from the ADjoin study further validate the promising efficacy and safety profile of lebrikizumab in people with moderate-to-severe atopic dermatitis. These results demonstrate that monthly maintenance dosing of lebrikizumab provides long-lasting relief from the distressing symptoms of this chronic disease, bringing us one step closer to offering a first-line biologic treatment option,” said Karl Ziegelbauer, Ph.D., Chief Scientific Officer at Almirall.

The two-year long-term extension data build on the positive one-year results previously published in British Journal of Dermatologyas well as the 16-week monotherapy data published in The New England Journal of Medicine. An additional 18 abstracts related to the lebrikizumab development program are being presented at the Fall Clinical Dermatology Conference that further explore key topics affecting patients with atopic dermatitis including key learnings from an exploratory analysis on lebrikizumab speed of response, itch-free days and stability of itch.

“Results from ADjoin reinforce the strong efficacy and safety profile of lebrikizumab seen in the other Phase 3 atopic dermatitis trials. These data also further our understanding of the long-lasting benefits of lebrikizumab as a potential first-line biologic treatment for patients,” said Lotus Mallbris, M.D., Ph.D., senior vice president of global immunology development and medical affairs at Eli Lilly and Company.

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 U.S. and the rest of the world outside Europe.

About ADjoin

ADjoin (NCT04392154) evaluated the efficacy and safety of lebrikizumab treatment for two years. Patients taking lebrikizumab who achieved IGA 0,1 or EASI-75 at 16 weeks in ADvocate 1 and 2 and ADhere were enrolled in ADjoin. Patients in the long-term extension trial received either lebrikizumab 250-mg every two weeks or monthly.¹

About lebrikizumab and Clinical Development Program

Lebrikizumab is an investigational, monoclonal antibody that binds IL-13 to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13.^2-4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.^5,6

The lebrikizumab phase III program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies.

About Almirall

Almirall is a global biopharmaceutical company focused on medical dermatology. We collaborate with scientists and healthcare professionals to address patients' 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 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has focused intensely on patients' needs. Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenue in 2022 was €878.5MM.

For more information, please visit www.almirall.com.

Legal warning

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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1} Guttman-Yassky E, et al. Efficacy and Safety of Lebrikizumab Is Maintained to Two Years in Patients With Moderate-to-Severe Atopic Dermatitis​. 2023 Fall Clinical Dermatology Conference. 20 October, 2023.
² Simpson EL, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017.
³ Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7.
⁴ Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024.
⁵ Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954
⁶ Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018.

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