LEO Pharma presents interim data from Phase 3 tralokinumab long-term extension trial in moderate-to-severe atopic dermatitis at EADV 30th Congress

• Interim analysis of ECZTEND, an open-label extension trial, demonstrated sustained improvements in extent and severity of atopic dermatitis after two years of continuous treatment, with a 92.7% median EASI improvement from parent trial baseline¹
• Patients also reported improvements in itch severity and sleep interference¹
• The overall safety profile of tralokinumab was consistent with that observed in the parent trials²

BALLERUP, Denmark and MADISON, N.J.--(BUSINESS WIRE)-- LEO Pharma A/S, a global leader in medical dermatology, today announced results showing adult patients with moderate-to-severe atopic dermatitis maintained improvements in signs and symptoms, itch severity and sleep interference following two years of continuous treatment with tralokinumab.¹ Interim findings from the Phase 3 ECZTEND trial were shared as an oral presentation during the European Academy of Dermatology and Venereology (EADV) Congress 2021.

Tralokinumab is a high-affinity, human monoclonal antibody that specifically binds to and inhibits IL-13, a key driver of atopic dermatitis signs and symptoms.^3,4 It is an investigational therapy in clinical development and has not been approved by the U.S. Food and Drug Administration. This interim analysis in the ECZTEND trial (NCT03587805) investigated continued treatment with tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) as well as the ability to regain response after pausing and reinitiating tralokinumab.¹

“Atopic dermatitis is a debilitating disease that can cause severe itch for decades. As clinicians, we’re always looking for additional long-term treatment options that could offer consistent results over time for our patients,” said Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center in Portland, Oregon, and lead investigator for ECZTEND. “The data being presented at EADV are very encouraging because they showed that patients treated with tralokinumab maintained improvements in signs and symptoms of atopic dermatitis over several years.”

Long-term efficacy outcomes were assessed in patients (n=345) who had received two years of treatment with tralokinumab, including the full 52 weeks in the pivotal Phase 3 parent trials (ECZTRA 1 and 2) and 56 weeks in the ECZTEND trial.¹ Patients were split into three cohorts based on the length of time between their last dose of tralokinumab in the parent trial and their first dose in ECZTEND. Continuous treatment was defined as ≤5 weeks between the last dose in the parent trial and the first dose in ECZTEND (n=126), interrupted treatment was defined as 6-15 weeks (n=133), and >15 weeks (n=86) was considered a washout of treatment.¹

Patients who received continuous treatment with tralokinumab over two years experienced long-term control in atopic dermatitis signs and symptoms, as demonstrated by a median Eczema Area and Severity Index score (EASI) improvement from parent trial baseline of 92.7%.¹

Maintenance of improvements in patient-reported outcomes, including pruritus (itch) severity and sleep interference, were demonstrated at two years as well. Itch severity and sleep interference were reported using a Numeric Rating Scale (NRS) of 0-10. Patients who received continuous treatment reported improvements in itch severity, with worst weekly NRS shifting from 8.1 (severe) at parent trial baseline to 3.0 (mild) following two years of treatment. Improvements in median NRS score for sleep interference were also reported after two years of treatment, from 7.3 (severe sleep interference) at parent trial baseline to 1.0 (mild sleep interference) in ECZTEND. During the parent trials, patients recorded their daily itch and sleep interference, and weekly averages of scores were used.⁵ During ECZTEND, worst itch severity and sleep interference of the previous week were reported.¹

“These data show a sustained response across both clinical and patient-reported measures of atopic dermatitis such as itch reduction and sleep interference, which create a significant burden for patients living with this chronic and unpredictable disease,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “The development of tralokinumab is a significant advancement in our commitment to improving the standards of care in medical dermatology to help better patient lives.”

A decline in median improvement in EASI was observed in the washout cohort within the period without treatment. After one year of treatment in the parent trial, results showed a median EASI percent improvement of 86.9% compared to baseline. Following the washout of treatment (>15 weeks), median EASI percent improvement (vs. parent trial baseline) declined to 68.6%. Within 12 weeks from treatment re-initiation with tralokinumab in ECZTEND, patients regained a median EASI percent improvement equivalent to response at one year in the parent trials.¹

The safety of tralokinumab treatment was also assessed in this interim analysis and the adverse event profile was consistent with the parent trials.²

To view the full presentation, visit https://www.leopharmaposters.net/eadv2021/1lhjkvcx.

About tralokinumab

Tralokinumab is a fully human, high-affinity, monoclonal antibody developed to specifically neutralize IL-13, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Tralokinumab specifically binds to IL-13 with high affinity, thereby preventing interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).^3,4

Tralokinumab was approved by the European Commission for adults with moderate-to-severe atopic dermatitis in Europe and by the Medicines & Healthcare products Regulatory Agency in Great Britain, respectively in June 2021. Additional regulatory filings are underway with other health authorities worldwide.

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 tralokinumab in patients with atopic dermatitis who participated in the previous tralokinumab monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab 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 tralokinumab plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab 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 tralokinumab or placebo.^1,6

About ECZTRA 1 and ECZTRA 2 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of tralokinumab (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁵

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.⁷ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁸ Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.³

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. 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, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information, please visit www.LEO-Pharma.com.

References

1. Blauvelt A et. al. Two-year Maintenance of Response with Tralokinumab in Moderate-to-Severe Atopic Dermatitis: Interim Analysis of the ECZTEND Open-label Extension Trial. European Academy of Dermatology and Venereology (EADV). Sept 29-Oct 2, 2021. On-demand video oral presentation FC01.04.
2. Blauvelt A et al. Long-term Improvements Observed in Tralokinumab-treated Patients With Moderate-to-severe Atopic Dermatitis: An ECZTEND Interim Analysis. American Academy of Dermatology Association Virtual Meeting Experience (AAD VMX); April 23-25, 2021. On-demand video oral presentation 29393.
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
4. 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.
5. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.
6. 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.
7. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
8. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.

September 2021 MAT-49581

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