Business Wire

LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021

Share

LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

Tralokinumab is a high affinity, human monoclonal antibody that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.2,3 It is an investigational therapy in clinical development, and its safety and efficacy are currently being evaluated by regulatory authorities.

The interim analysis at 56 weeks in the ECZTEND trial (NCT03587805) showed tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) demonstrated long-term improvements in itch, sleep, and in atopic dermatitis signs and symptoms.1 Patients who had enrolled in pivotal Phase 3 trials ECZTRA 1 and 2 who continued into ECZTEND were on treatment for at least two years.1

“Atopic dermatitis is a complex, chronic skin disease that can have devastating and lasting impacts due to the unpredictable nature of the disease. Since patients can live with atopic dermatitis for decades, clinicians are looking for new treatment options that provide predictable long-term results,” said Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center in Portland, Oregon, and lead investigator for ECZTEND. “We are encouraged by the sustained improvements seen over time in patients treated with tralokinumab in the ECZTEND trial, showing great potential for a promising new treatment option for adults living with uncontrolled moderate-to-severe atopic dermatitis.”

The ongoing 268-week open-label extension trial is investigating the long-term safety and efficacy of tralokinumab 300 mg every other week in patients who previously participated in parent trials ECZTRA 1-8 and TraSki investigator-initiated study.1 The primary endpoint was defined as the number of adverse events during the treatment period from baseline up to Week 268.1

Interim analysis at Week 56 included patients from parent trials ECZTRA 1, 2, ECZTRA 3 and ECZTRA 5. Interim efficacy results at Week 56 were based on the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).1

IGA 0/1 (% of
patients [n/N])

EASI
Score
(Median)

EASI % Change
From Parent Trial
Baseline (Median)

EASI-50

(% of
patient [n/N])

EASI-75
(% of
patients [n/N])

EASI-90
(% of
patient [n/N])

EASI ≤7
(% of
patients [n/N])

Pruritus
NRS Worst
Weekly
Score

(Mean
[SD])

Eczema-
related
Weekly Sleep
NRS Score

(Mean [SD])

Week 56

49.7 (255/513)

1.8

-93.6

95.1 (488/513)

82.8 (425/513)

61.0 (313/513)

79.7 (409/513)

3.3 (2.6)

2.0 (2.4)

Participants included 1,174 patients from ECZTEND at data cut-off.1 Observed outcomes for all patients enrolled 60 weeks prior to data cut-off (n=513) were analyzed at Week 56.1 At parent-trial baseline, ECZTEND baseline, and Week 56, median EASI score was 26.6, 4.7, and 1.8, respectively.1 At Week 56, IGA and EASI response rates were 49.7% (IGA 0/1), 95.1% (EASI-50), 82.8% (EASI-75), 61.0% (EASI-90), and 79.7% (EASI ≤7). An EASI score of ≤7 corresponds to mild atopic dermatitis.1

At the same 56-week data cut-off, measurements of itch and sleep disruptions due to itch were also reported.1 At Week 56, the mean worst weekly pruritus (i.e. itch) numeric rating scale (NRS) score was 3.3 (parent-trial baseline was 7.7) while the mean eczema-related weekly sleep NRS score was 2.0 (parent-trial baseline was 6.9).1

In the two-year cohort of patients who completed 52 weeks of tralokinumab treatment in parent studies (ECZTRA 1 and 2) and at least 56 weeks in ECZTEND (n=291), observed EASI response rates were 93.8% (EASI-50), 82.5% (EASI-75), and 59.8% (EASI-90), demonstrating sustained efficacy after two years of treatment.1 The efficacy and response rates demonstrated by this two-year cohort were consistent with that of the overall group at data cut-off (56 weeks).1These results indicate patients receiving long-term treatment with tralokinumab sustained the response rates and improvements in itch and sleep achieved in the parent trials.1

The long-term safety of tralokinumab treatment were also assessed.4 By the data cut-off, 11.8% of patients had withdrawn from the study, and discontinuation rates due to an adverse event were low (1.6%).4

In the safety analysis set (n=1,174), from the start of the ECZTEND trial to data cut-off, 71.9% of patients experienced an adverse event; most were mild or moderate in severity.4 The most frequently reported adverse events (≥5% of patients receiving tralokinumab) included viral upper respiratory tract infection (mainly reported as common cold; 21.3%), atopic dermatitis (13.5%), and upper respiratory tract infection (7.1%). Conjunctivitis was reported in 5.9% of patients.4

“Atopic dermatitis is a condition that can impact patients over decades, which is why we are very encouraged by these long-term study results that show the potential of tralokinumab over time,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “Tralokinumab is currently being evaluated by health authorities around the world, and we hope to introduce this targeted treatment option soon.”

LEO Pharma recently received a positive opinion for tralokinumab from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on April 23, 2021.

Additional data will be presented by LEO Pharma at AAD VMX, including a sub-analysis of the pivotal Phase 3 trial, ECZTRA 1, that showed the impact of tralokinumab on skin barrier abnormalities.

About tralokinumab
Tralokinumab is a human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Tralokinumab specifically binds to the IL-13 cytokine with high affinity, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).2,3

About the ECZTEND - Long-Term Extension (LTE)Trial
ECZTEND is a Phase 3, long-term (up to 268 weeks), 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), and 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).5

About ECZTRA 1, 2, ECZTRA 3 and ECZTRA 5 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 efficacy and safety of tralokinumab (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.6

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the efficacy and safety of tralokinumab (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.7

ECZTRA 5 (ECZema TRAlokinumab trial No. 5) was a randomized, double-blind, placebo-controlled, 30-week, Phase 2 trial which included 215 adult patients with atopic dermatitis to evaluate the effect of tralokinumab (300 mg) on vaccine antibody responses (Tdap and meningococcal vaccines) in adults with moderate-to-severe atopic dermatitis who are candidates for systematic therapy. Patients were treated with either tralokinumab or placebo for 16 weeks. The safety, efficacy, and tolerability of tralokinumab when administered with the studied vaccines was also assessed.8

About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.9Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.10 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.2

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 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. 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.
  2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
  3. 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.
  4. Blauvelt A, et al. Long-term Safety, Efficacy, and Adherence to Tralokinumab Treatment in Moderate-to-severe Atopic Dermatitis for up to 3 Years: Interim Readout of ECZTEND, a Phase 3, Long-term Extension Trial. American Academy of Dermatology Association Virtual Meeting Experience (AAD VMX); April 23-25, 2021. E-poster 27697.
  5. 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.
  6. 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.
  7. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463.
  8. Merola J, et. al. Tralokinumab Does Not Impact Vaccine-induced Immune Responses: Results From a 30-week, Randomized, Placebo-controlled Trial in Adults With Moderate-to-severe Atopic Dermatitis. (EZCTRA 5) J Am Acad Dermatol. 2021.
  9. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
  10. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

April 2021 MAT-42680

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Linda Mayer
Global Product Communications
+1 973 908 7924
limay@leo-pharma.com

Henrik Kyndlev
Global External Communications
+45 3140 6180
hdtdk@leo-pharma.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

ADVA adds encryption to flagship 10G edge device11.5.2021 09:00:00 CEST | Press release

ADVA (FSE: ADV) today launched its FSP 150-XG118Pro (CSH), addressing urgent enterprise demand for high-bandwidth connectivity with robust security. The new member of the ADVA FSP 150 programmable demarcation and edge compute portfolio supports 10Gbit/s MEF 3.0 Carrier Ethernet and IP services, provides precise synchronization capabilities and now features hardware-based encryption. With its comprehensive MACsec security, the ADVA FSP 150-XG118Pro (CSH) enables business data to pass safely and seamlessly across untrusted public networks and empowers communication service providers (CSPs) to offer fully encrypted bandwidth services. What’s more, like ADVA’s FSP 3000 transport solution, the ADVA FSP 150-XG118Pro (CSH) is ready to run post-quantum cryptographic (PQC) algorithms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511005059/en/ ADVA’s new FSP 150 will prove key for businesses seeking ultimate security for high-cap

21st BraunPrize Seeks to Reward Good Design That Will Shape Tomorrow11.5.2021 09:00:00 CEST | Press release

Braun celebrates its 100th anniversary in 2021 and we are pleased to announce the 21st BraunPrize International Design Competition, with a virtual awards ceremony due to take place in October 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511005118/en/ Established in 1968, the BraunPrize was Germany’s first international competition with the aim to promote the work of young designers. Braun’s continuous commitment to this cause has been highly regarded by the design world and the design-aware public ever since. This year, young, up-and-coming designers and inventors will be tasked with exploring good design to address and solve the challenges of today and tomorrow; and Braun’s commitment to nurturing young talent will see this year’s total prize value increase to $100,000 USD. A recent global study, conducted by Braun of 18-25 year olds, revealed that Gen Z believes that good design will play a pivotal role in its f

Galderma Launches CETAPHIL® Line for Sensitive Skin and New DAYLONG® Sun Protection Product in Switzerland11.5.2021 09:00:00 CEST | Press release

Galderma has expanded its consumer care portfolio in Switzerland, where the global dermatology company originated and is headquartered. The expansion offers consumers more options for their dermatology needs. The move includes the introduction of the dermatologist-recommended CETAPHIL® line for sensitive skin, as well as the expansion of the DAYLONG® brand for sun protection. CETAPHIL is now available in Switzerland CETAPHIL, the sensitive skincare line recommended by dermatologists worldwide, is now available in Switzerland, exclusively in pharmacies and drugstores. The entry of the CETAPHIL range into the dermo-cosmetic market means consumers now have more choice of topical skincare for sensitive skin. Swiss consumers can now purchase the core range of CETAPHIL moisturizing creams, moisturizing lotion and gentle skin cleanser. Additionally, the CETAPHIL PRO range for special skin conditions completes the CETAPHIL portfolio. The brand enters the dermo-cosmetic market as a complementar

Curve Launches New Crowdfund to Bring Customers Closer to its Growth Journey11.5.2021 09:00:00 CEST | Press release

Curve, the fast-growing financial super app, today announces it’s launching a new crowdfunding round to enable its growing customer base to invest, as it fuels its expansion into the US and further into Europe. The campaign is set to go live sometime in May. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511005170/en/ Curve Launches New Crowdfund to Bring Customers Closer to its Growth Journey (Graphic: Business Wire) Having secured £72.5 million from a leading group of international investors as part of its successful Series C round, Curve is now extending the opportunity to its customers and wider community to take part in the next stage of its ambitious growth strategy. Since its record-breaking crowdfund in 2019, which raised £4 million within 42 minutes, Curve’s valuation has tripled. In the last year alone, Curve hired over 100 new staff, doubled its customer base to over two million, and saw the volume of transacti

Takeda Delivers Resilient FY2020 Results With Strong Margins & Robust Cashflow; Underlying Revenue Growth Expected to Accelerate in FY202111.5.2021 08:35:00 CEST | Press release

Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) (“Takeda”) today announced financial results for fiscal year 2020 (period ended March 31, 2021). TAKEDA PRESIDENT AND CHIEF EXECUTIVE OFFICER CHRISTOPHE WEBER commented: “Over the course of FY2020, Takeda remained resilient as we operated in new ways through the COVID-19 pandemic. This is a testament to the dedication of our employees, and Takeda’s unwavering commitment to serving patients, our people, and the planet to bring better health for people and a brighter future for the world. We maintained business continuity, ensured patient access to our medicines and safeguarded the health and well-being of our employees while helping to address the pandemic. “This focus enabled us to deliver on our full-year management guidance, with underlying revenue growth driven by our 14 global brands, and the acceleration of cost synergies contributed to strong margins and a robust cashflow. Furthermore, we continued to experience growth

EMG Announces Appointment of Shaun Gregory as New Group Chief Executive Officer11.5.2021 08:30:00 CEST | Press release

EMG, a leading global provider of broadcast facilities and media solutions, announced today that Shaun Gregory will join the company as Group Chief Executive Officer starting May 17th 2021. Gregory is a seasoned executive with over 30 years of experience in the media, telecommunications & broadcasting industries. He has served as Chief Executive Officer for some of the fastest growing companies, both in Europe and globally. Under his leadership, EMG will continue the development of its ambitious transformation strategy. He will succeed co-CEO Patrick van den Berg who after 15 years serving in various leadership positions at EMG will take on a new professional challenge while co-CEO François-Charles Bideaux will become advisor to the CEO & EMG board focusing on specific areas such as sales, technology and M&A. Most recently, Gregory was CEO of media localization company IYUNO Media Group (formerly BTI Studios) which spans 46 countries and 88 language types, servicing the world’s leading

Altium Announces Cloud Platform To Connect Electronics Industry Ecosystem11.5.2021 08:30:00 CEST | Press release

Altium LLC is announcing the launch of Nexar, the cloud-based partner platform designed to connect the rapidly growing community of Altium 365 PCB design users and their companies with the software, suppliers, and manufacturers needed to transform ideas into smart & connected products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210510006069/en/ Electronics industry researchers estimate that there are 31 billion internet-connected devices in the world today, with consumer demand growing that number to 75 billion by 2025. Growth of that magnitude is driving the need to reimagine the way that the electronics industry works together, evolving from “tool chains” and isolated job functions to integrated environments and collaborative workflows. Over 5,000 companies and 11,000 users have already adopted the Altium 365 cloud platform for electronics design. With the introduction of Nexar, partners can join this ecosystem of elec

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom