LEO Pharma Presents New Adbry™ (tralokinumab-ldrm) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at AAD 2023 Annual Meeting

• Analysis from the ECZTRA 6 trial shows positive effects of Adbry on reducing Staphylococcus aureus skin colonization that contributes to skin irritation and infections, and improving gene expression toward a non-lesional skin profile in adolescents with moderate-to-severe atopic dermatitis (AD).^1,2
• Interim analysis of adolescent patients in the ECZTEND trial demonstrates that long-term use of Adbry for up to three years had a similar safety profile to the adult population, and approximately eight out of 10 patients had at least a 75% improvement in the extent and severity of their AD (EASI-75) at two years.³

LEO Pharma A/S, a global leader in medical dermatology, today presented new clinical data from the ECZTRA 6 and ECZTEND trials of Adbry™ (tralokinumab-ldrm), marketed outside of the U.S. under the tradename Adtralza®, in adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD). The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA.

New data from the ECZTRA 6 trial showed that Adbry significantly reduced the abundance of Staphylococcus aureus in the lesional and non-lesional skin of adolescents with AD after 16 weeks. S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections. A correlation between disease severity and S. aureus colonization has been demonstrated in clinical studies.⁴ At Week 16, 49% of patients receiving Adbry 150 mg (n=81) and 43% of patients receiving Adbry 300 mg (n=82) went from testing positive for S. aureus to negative in lesional skin, compared to the 14% receiving placebo (n=80). Similar reductions were seen in Adbry-treated patients with S. aureus positive non-lesional skin.¹

“Patients with atopic dermatitis are often colonized with high levels of S. aureus,” said Prof. Lisa Beck, Department of Dermatology, University of Rochester Medical Center, and the lead investigator on this analysis. “These data demonstrate the impact of Adbry’s IL-13 neutralization in effectively reducing S. aureus abundance in adolescents, an important factor in the aggravation of skin lesions and skin infections.”

Additional data in adolescent patients from ECZTRA 6 demonstrated that 16 weeks of treatment with Adbry showed an improvement in skin gene expression from a lesional to a non-lesional skin profile. The improvement occurred in 29% (n=29) and 41% (n=27) of the differentially expressed genes in lesional skin in patients treated with Adbry (for the 150 mg and 300 mg groups, respectively), compared to a 4% improvement in the placebo group (n=27). At Week 8, Adbry 150 mg and 300 mg led to 35% 9 (n=29) and 33% (n=27) improvement respectively in gene expression, compared to a 10% (n=27) improvement with placebo.²

All participants who completed the ECZTRA 6 trial were eligible to enter the ongoing ECZTEND open-label extension trial. An interim analysis of this trial, also presented at AAD, evaluated the long-term safety and efficacy of Adbry among adolescents from ECZTRA 6 who moved into ECZTEND.

The results of the analysis showed that the long-term safety profile of Adbry for up to three years in the adolescent population (n=127) was consistent with that of the ECZTEND adult population, with no new safety issues identified. The pattern of frequently reported adverse events (AEs) in ECZTEND was similar to that observed with Adbry in the parent trial, although at lower rates. The most frequently reported AEs in the ECZTEND adolescent population were viral upper respiratory tract infection (11.9 events per 100 patient years of exposure (PYE)), dermatitis atopic (7.4 events per 100 PYE), and upper respiratory tract infections (4.5 events per 100 PYE).³ Of note, was the lower frequency rate of conjunctivitis observed in patients being treated with Adbry compared to those in the placebo group. Of the AEs of special interest, no events of keratitis or keratoconjunctivitis, eczema herpeticum skin infections requiring systemic treatment, or malignancies were reported.³

Additionally, approximately eight out of 10 patients had at least a 75% improvement in the extent and severity of AD (EASI-75) at two years of treatment with Adtralza (84.4% AO (n=109), 78.7% mNRI (n=127), 78.7% LOCF (n=127).³

“These new insights from the ECZTRA 6 study further develop our understanding of how Adbry works in adolescent patients and its effect on the spread of S. aureus colonization, a common and significant issue that can exacerbate skin infections,” said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “In addition, the latest analysis of data from adolescents in the ECZTEND study shows the long-term safety and efficacy profile of Adbry. Our goal is to use these findings to better inform disease management strategies for healthcare providers and their patients.”

Adbry was approved for adults by the U.S. Food and Drug Administration (FDA) in December 2021. The use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA. It is marketed outside of the U.S. under the tradename Adtralza^® and is approved for the treatment of adults and adolescents with moderate-to-severe AD in Canada, the European Union, and Great Britain. Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., United Arab Emirates, Switzerland, and Japan.

About Adbry^™ (tralokinumab-ldrm)

Adbry^TM (tralokinumab-ldrm) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^5,6 Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).⁶

About the ECZTRA 6 Trial

ECZTRA 6 is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, with 289 patients aged 12 to 17 (195 Adbry patients and 94 placebo patients), evaluating the efficacy and safety of Adbry (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁷

About the ECZTEND - Long-Term Extension (LTE) Trial

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adbry in patients with atopic dermatitis who participated in the previous Adbry monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adbry plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy Adbry plus TCS trial in Japanese subjects (ECZTRA 8), and the Adbry monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adbry or placebo.^3,8,9

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁴ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁰ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^5,6

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

• ADBRY^TM (tralokinumab-ldrm) injection is a prescription medicine used to treat adults with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject more ADBRY than prescribed, call Poison Control at 1-800-222-1222.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

References:

1. Beck LA, Weidinger S, Tauber M, et al. Neutralizing interleukin-13 with tralokinumab reduces abundance of S. aureus in adolescents with atopic dermatitis. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, La., March 17-21, 2023.
2. Da Rosa JC, Simpson E, Soong W, et al. Tralokinumab modulates the transcriptomic profile of lesional and non lesional skin in adolescents with moderate to severe atopic dermatitis assessed by tape stripping. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, La., March 17-21, 2023.
3. Simpson E, Paller A, Wollenberg A, et al. Long term safety and efficacy of tralokinumab in adolescents with moderate to severe atopic dermatitis: an interim analysis of ECZTEND. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, La., March 17-21, 2023.
4. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
5. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
6. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208-19.
7. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: NCT03526861. https://clinicaltrials.gov/ct2/show/NCT03526861.
8. Blauvelt A, Langley RG, Lacour JP, et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022;87(4):815-824.
9. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier: NCT03587805. https://clinicaltrials.gov/ct2/show/NCT03587805.
10. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.

MAT-64516 March 2023

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