BMPR2

TREK-DX, the first randomized, double-blind, placebo-controlled study to be conducted in a dupilumab-experienced atopic dermatitis (AD) patient population, has started enrolling patients in the US under an updated protocol; new European sites are on track to open in the first half of 2024 In a preliminary review of blinded data from 22 patients treated to date, 45% (10/22) of patients saw at least a 90% reduction in their EASI score (EASI-90) and 50% (11/22) of patients achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks. Topline unblinded data from the full dataset is expected at the end of 2024 Translational data demonstrates differentiated effects of targeting IL-13R versus IL-4R, suggesting eblasakimab has the potential to be effective in AD patients that do not achieve an adequate response to dupilumab, a significant and underserved patient population with few safe and long-term treatment options SAN MATEO, Calif. and SINGAPORE, March 11, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has begun to enroll patients in the US under an updated protocol in the ongoing TREK-DX trial, studying eblasakimab in dupilumab-experienced patients with moderate-to-severe atopic dermatitis (AD). TREK-DX is the first randomized, double-blind, placebo-controlled trial to be conducted in AD patients who have been previously treated with dupilumab, a market estimated to reach $10 billion by 20291. Based on findings from the TREK-AD study which highlighted the changing AD patient population in the US, the TREK-DX inclusion criteria have been tightened to enroll patients with a baseline Eczema Area and Severity Index (EASI) score of at least 18, instead of 16. In conjunction with this, independent reviewer confirmation of baseline EASI scores has also been implemented. US sites are now enrolling patients according to the updated criteria and additional sites in Europe are on track to open in the first half of 2024. TREK-DX will enroll approximately 75 patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event, and treat them with either 400mg eblasakimab or placebo once weekly for 16 weeks. At the time of the data cut off for this preliminary review of blinded data from 22 patients enrolled under the original inclusion criteria, who were randomized 2:1 active to placebo, 17 patients completed the 16 week treatment period and 5 patients discontinued before the completion of the 16 week treatment period. At 16 weeks or the last visit, EASI score decreased at least 90% (EASI-90) in 10 patients, or 45%, and 11 patients, or 50%, achieved a validated Investigator Global Assessment (vIGA) score of 0 or 1 (clear or almost clear skin). Of the 9 patients who previously had an inadequate response to dupilumab, 5 patients (56%) achieved EASI-90 and 5 patients (56%) a vIGA score of 0 or 1. Treatments have been well-tolerated to date and no new safety signals were identified. There have been no reports of conjunctivitis and no reports of injection site reactions. Topline unblinded data from the full dataset is expected at the end of 2024. “63% of dupilumab-treated patients fail to achieve clear or almost clear skin (IGA score of 0 or 1) after 16 weeks2, and around half of those patients that do achieve this response do not maintain it after the subsequent 36 weeks3, so there is a significant need for additional biologic therapies that could provide a safe and efficacious long-term treatment option for patients that do not achieve an adequate response to dupilumab. EASI-90 and vIGA are among the most stringent of endpoints in AD studies. Although this is based on a preliminary review of the blinded data, we are encouraged to observe a high percentage of patients in the TREK-DX study meeting these endpoints to date. Our market research found that most AD patients are only moderately satisfied with their current treatment. This, together with the translational data we have generated, supports the potential role of eblasakimab as a treatment for these patients, and the data we are generating in the TREK-DX study could demonstrate that, for many patients, eblasakimab could control their disease even where dupilumab has not,” saidDr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals. Translational data demonstrates differentiated effects of targeting IL-13R versus IL-4R, suggesting eblasakimab has the potential to be effective even in instances where dupilumab is not Eblasakimab targets the IL-13 receptor (IL-13R) subunit of the Type 2 receptor, preventing signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13). Both are key drivers of inflammation in AD, however, recently published translational data highlighted the advantages of targeting IL-13R by eblasakimab over the IL-4 receptor (IL-4R), the target of dupilumab, in AD patient peripheral blood mononuclear cells4. IL-13R blockade resulted in more efficient reduction of cytokines implicated in Type 2-driven (allergic) inflammation compared to IL-4R blockade, as well as lower levels of Type 1 pro-inflammatory cytokines. Additional data from head-to-head studies between eblasakimab and dupilumab in skin biopsies from AD patients confirmed the differentiated effects of targeting IL-13R versus IL-4R5. In this study, eblasakimab reduced localized secretion of pro-inflammatory Type 2 cytokines by the skin tissue more efficiently than dupilumab, suggesting eblasakimab could have the potential to be effective in AD patients that do not achieve an adequate response to dupilumab. References Decision Resources Group (2023) Atopic Dermatitis Disease Landscape and Forecast Report Thaci et al (2019) J Dermatol Sci 94(2):266-275 Worm et al (2020) JAMA Derm 156(2):131-143 Cevikbas et al (2023) 1st International Society of Investigative Dermatology Meeting, May 10-14, 2023 Cevikbas et al (2023) 7th Annual Dermatology Drug Development Summit, October 31-November 2, 2023 About TREK-DX TREK-DX trial is a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of eblasakimab in patients with moderate-to-severe AD previously treated with dupilumab. The trial will enroll approximately 75 patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event. The trial consists of a 16-week treatment period and an 8-week safety follow-up period. The primary efficacy endpoint is percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. Key secondary efficacy endpoints include the proportion of patients achieving validated Investigator Global Assessment (vIGA) score of 0 (clear) or 1 (almost clear), proportion of patients with a 75% or greater reduction in EASI (EASI-75), proportion of patients achieving EASI-50 and EASI-90, and changes in peak pruritus. About eblasakimab Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor subunit of the Type 2 receptor, a key pathway driving several allergic inflammatory diseases. Eblasakimab’s unique mechanism of action enables specific blockade of the Type 2 receptor and has the potential to improve upon current biologics used to treat allergic disease. By blocking the Type 2 receptor, eblasakimab prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13) – the key drivers of inflammation in AD and Type 2 driven COPD. Positive results from the Phase 2b TREK-AD study in moderate-to-severe AD support eblasakimab’s potential to deliver a monthly dosing regimen from initiation in AD without compromising on efficacy and with an encouraging safety pro to date, with preparations for Phase 3 underway. ASLAN is also investigating eblasakimab in dupilumab experienced, moderate-to-severe AD patients in the Phase 2 TREK-DX study. About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b, dose-ranging study in moderate-to-severe AD patients. ASLAN is also investigating eblasakimab in dupilumab experienced, moderate-to-severe AD patients in the Phase 2 TREK-DX study with a topline data readout expected at the end of 2024. Farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), is being developed by ASLAN as a potential first-in-class treatment for alopecia areata (AA) in a Phase 2a, proof-of-concept trial with an interim readout expected in mid-2024. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit ASLAN’s website or follow ASLAN on LinkedIn. Forward-looking statements This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize eblasakimab; statements related to the safety and efficacy of eblasakimab, including preliminary blinded data; the Company’s plans and expected timing with respect to manufacturing activities, clinical trials, clinical trial enrolment and clinical trial results for eblasakimab; and the potential of eblasakimab as a first-in-class treatment for atopic dermatitis. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials; risks that trends or characteristics based on preliminary blinded data may not be consistent with unblinded data; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of geopolitical conflicts and bank failures on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. ASLAN Media and IR contacts Emma Thompson Spurwing Communications Tel: +65 6206 7350 Email: ASLAN@spurwingcomms.com Ashley R. Robinson LifeSci Advisors, LLC Tel: +1 (617) 430-7577 Email: arr@lifesciadvisors.com

New translational data from a head-to-head study of eblasakimab and dupilumab in a human tissue model of COPD shows eblasakimab performed better than dupilumab in improving airway function and enhancing bronchodilation at the same concentrationsLeading respiratory experts, Ramaswamy Krishnan, PhD, and Reynold Panettieri, MD, appointed as scientific advisors to provide strategic counsel on eblasakimab’s differentiation for future clinical development in COPD SAN MATEO, Calif. and SINGAPORE, March 06, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced new positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of chronic obstructive pulmonary disease (COPD) that provides further support for the potential of eblasakimab as a biologic therapy for COPD. In addition, the Company announced the appointment of respiratory experts Dr Ramaswamy Krishnan, MS MPhil PhD, Associate Professor in Emergency Medicine, Harvard Medical School, and Dr Reynold Panettieri Jr, MD, Vice Chancellor, Translational Medicine and Science, Rutgers University to ASLAN’s Scientific Advisory Board as it evaluates the potential use of eblasakimab as a therapy to treat COPD in addition to atopic dermatitis (AD). “Having collaborated with the ASLAN team on the impressive translational data from the head-to-head study of eblasakimab and dupilumab in COPD patient tissue, I am pleased to formally join the Scientific Advisory Board to further explore eblasakimab’s potential in COPD,” said Dr Ramaswamy Krishnan, MS MPhil PhD, Associate Professor in Emergency Medicine, Harvard Medical School. “I’m delighted to work with the ASLAN team on this exciting opportunity to evaluate development paths for eblasakimab in COPD, a Type 2-driven disease. I believe there’s a great opportunity for biologics to transform the treatment landscape for this chronic condition, just as we have observed in the management of other respiratory diseases such as severe asthma. These new data suggest eblasakimab has the potential to be a best-in-class biologic treatment for COPD and I look forward to our partnership,” said Dr Reynold Panettieri Jr, MD, Vice Chancellor, Translational Medicine and Science, Rutgers University. In November 2023, ASLAN announced translational data from healthy donor tissue that suggested eblasakimab’s potential as a COPD therapeutic to inhibit Type 2 inflammation. Further studies have been conducted using lung tissue from a COPD patient, comparing the same concentrations of eblasakimab and dupilumab. Each treatment condition was tested in at least 6 precision cut lung slices. In the COPD patient tissue, eblasakimab was effective in restoring constriction in response to challenges with IL-4 and IL-13, and demonstrated rapid, formoterol-induced airway dilation in constricted airways. Formoterol is a long-acting beta agonist, a class of drugs commonly used by asthmatic and COPD patients to treat their disease. Notably, this preliminary data showed eblasakimab performed better than dupilumab at the same concentrations in several areas, including the restoration of airway function after challenges with IL-4 and IL-13. “We believe that eblasakimab has the potential to be a leading treatment option as we explore its applicability in other diseases besides AD, such as COPD, a large, underserved market with no approved biologics. We look forward to working with Drs Krishnan and Panettieri, and potential partners, to consider potential proof-of-concept Phase 2 study designs in COPD and exploring novel endpoints from recently conducted biologic studies,” said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals. Further translational data on eblasakimab in COPD will be submitted for publication at upcoming scientific congresses. About Ramaswamy Krishnan, MS MPhil PhD, Associate Professor in Emergency Medicine, Harvard Medical School Ramaswamy Krishnan, PhD, is an Associate Professor of Emergency Medicine at Harvard Medical School. His laboratory focuses on lung mechanics and mechanotransduction, with an emphasis on how airways contract and relax. To this end, he has invented a suite of technologies to measure airway cell and tissue contraction, relaxation, force transmission, and force transduction. These technologies have not only enabled the discovery of new drug candidates for COPD and asthma in his own laboratory, but are also being utilized worldwide as translational approaches for assessing bronchoprotective and bronchodilatory function of pending candidate medications. Dr Krishnan received his PhD in mechanical engineering from Columbia University and undertook his postdoctoral research in lung physiology at Harvard. He has published over 75 articles, reviews, editorials and chapters, many in renowned peer-reviewed journals including Nature Cell Biology and Nature Materials. About Dr Reynold Panettieri Jr, MD Vice Chancellor, Translational Medicine and Science, Rutgers University Reynold A Panettieri Jr, MD, is the inaugural Director of the Institute for Translational Medicine and Science and Vice Chancellor for Translational Medicine and Science at Rutgers University, having previously served as the Director of the Airways Biology Initiative at the University of Pennsylvania. Dr Panettieri’s lab focuses on the immunobiology of airway smooth muscle, impact of environmental toxins on airway hyperresponsiveness and identification of novel targets and platforms for therapeutic approaches in asthma and COPD. In addition to his research and clinical interests, Dr Panettieri served as chairperson of the NIH Lung Cellular, Molecular and Immunobiology Study Section, and is a member of the NIH Distinguished Editorial Panel. Dr Panettieri has about 450 publications and undertook his medical training at the University of Pennsylvania. About eblasakimab Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor subunit of the Type 2 receptor, a key pathway driving several allergic inflammatory diseases. Eblasakimab’s unique mechanism of action enables specific blockade of the Type 2 receptor and has the potential to improve upon current biologics used to treat allergic disease. By blocking the Type 2 receptor, eblasakimab prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13) – the key drivers of inflammation in AD and Type 2-driven COPD. Positive results from the Phase 2b TREK-AD study in moderate-to-severe AD support eblasakimab’s potential to deliver a monthly dosing regimen from initiation in AD without compromising on efficacy and with an encouraging safety profile demonstrated to date, with preparations for Phase 3 underway. ASLAN is also investigating eblasakimab in dupilumab-experienced, moderate-to-severe AD patients in the Phase 2 trial, TREK-DX. About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. ASLAN is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH) as a potential first-in-class treatment for alopecia areata (AA) in a Phase 2a, proof-of-concept trial with an interim readout expected in mid-2024. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the ASLAN website or follow ASLAN on LinkedIn. Forward-looking statements This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to manufacturing activities, clinical trials, clinical trial enrolment and clinical trial results for eblasakimab and farudodstat; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a first-in-class treatment for alopecia areata; the potential benefits, capabilities and results of the Company’s collaboration efforts; and the Company’s cash runway. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; the fact that results of earlier studies and trials may not be predictive of future trial results; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic, the ongoing conflict between Ukraine and Russia and bank failures on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Media and IR contacts Emma ThompsonSpurwing CommunicationsTel: +65 6206 7350Email: ASLAN@spurwingcomms.comAshley R. RobinsonLifeSci Advisors, LLCTel: +1 (617) 430-7577Email: arr@lifesciadvisors.com

A catalog of Adbry tralokinumab-ldrm clinical and real-world data and investigational delgocitinib cream data is being presented across 10 posters at the 2024 Winter Clinical and Maui Derm Conferences.1-10 Investigational Delgocitinib cream data presentations include a pooled analysis of the DELTA 1 and DELTA 2 phase 3 clinical trials assessing health-related quality of life through the Dermatology Life Quality Index (DLQI) in patients with moderate to severe CHE.1 One of the five Adbry presentations is a six-month interim analysis examining real-world patient-reported outcomes in adult patients with moderate-to-severe AD living in the U.S.6 MADISON, N.J.--(BUSINESS WIRE)-- LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of investigational delgocitinib cream and Adbry® data across 10 posters at the upcoming Winter Clinical and Maui Derm conferences this month. The 2024 Winter Clinical Conference will take place Jan. 12-17 in Honolulu, Hawaii, while Maui Derm is being held from Jan. 22-26 in Maui, Hawaii. LEO Pharma is currently developing delgocitinib cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults. The safety and efficacy has not been evaluated by any health authority. Adbry is indicated for adult and pediatric patients (aged 12+ years) with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.11 “We look forward to sharing such a large volume of data with the clinical community at the Winter Clinical and Maui Derm Conferences,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer. “With these 10 presentations, we hope to demonstrate our leadership in the medical dermatology space and our continued commitment to patients with chronic hand eczema and atopic dermatitis." Five poster presentations on investigational delgocitinib cream will focus on data from the DELTA 1 and DELTA 2 phase 3 clinical trials.1-5 This includes a pooled analysis of the two trials evaluating the effect of delgocitinib cream on health-related quality of life versus cream vehicle, as measured by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe CHE.1 Five other posters will focus on Adbry data, covering both clinical and real-world results in adult (aged 18+ years) and pediatric (aged 12-17 years) patients.6-10 One poster examines a six-month interim analysis of a real-world study of adult patients with moderate-to-severe AD living in the U.S. The analysis includes patient-reported quality of life outcomes relating to itch, sleep, and treatment satisfaction when Adbry is used either in dupilumab-naïve or in dupilumab-experienced patients.6 The company’s full roster of accepted presentations at the 2024 Winter Clinical and Maui Derm Conferences is as follows: Investigational Delgocitinib Effect of delgocitinib cream 20 mg/g on Dermatology Life Quality Index in patients with moderate-to-severe Chronic Hand Eczema: pooled data from the DELTA 1 and DELTA 2 phase 3 trials. Author: Marie Louise Schuttelaar Poster presentation Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 2 trial. Author: Sibylle Schliemann Poster presentation Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 1 trial. Author: Robert Bissonnette Poster presentation Patient-reported itch and pain are correlated with clinician-assessed outcomes in Chronic Hand Eczema (CHE). Author: Tove Agner Poster presentation Systemic exposure of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the phase 3 DELTA 2 trial. Author: Diamant Thaçi Poster presentation Adbry® (tralokinumab-ldrm) Tralokinumab real-world patient-reported outcomes in moderate-to-severe atopic dermatitis adult patients in the United States: 6-month interim analysis. Author: Peter Lio Poster presentation Tralokinumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients aged 12 years and older with and without atopic comorbidities. Author: Amy Paller Poster Presentation Progressive and sustained disease control in patients with atopic dermatitis (AD) aged 12-17 years treated with tralokinumab for 52 weeks. Author: Andreas Wollenberg Poster Presentation Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control. Author: Andrew Blauvelt Poster Presentation Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials. Author: Kristian Reich Poster presentation About chronic hand eczema Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.12,13 HE is the most common skin disorder of the hands14 with a one-year prevalence rate of approximately 9%.15 In a substantial number of patients, HE can develop into a chronic disease.14 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.16 About atopic dermatitis Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.17 AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.18 The type 2 cytokine, IL-13, has been identified as a key cytokine in lesional and non-lesional skin and it plays an important role in atopic dermatitis pathophysiology, including immune dysregulation, skin-barrier dysfunction and itch.19,20 About delgocitinib Delgocitinib is an investigational topical pan-Janus kinase (JAK) inhibitor. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.21 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.22 LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About Adbry® (tralokinumab-ldrm) Adbry® (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.11,19 Adbry specifically binds to the IL-13 cytokine, thereby preventing the interaction with the IL-13 receptor α1 subunit of the Type 2 receptor and inhibiting the subsequent downstream IL-13 signaling.23,24 Adbry, which is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab), is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan. U.S. INDICATION AND IMPORTANT SAFETY INFORMATION What is ADBRY? ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older 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 under 12 years of age. 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. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting . 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 -too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 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: Upper respiratory tract infections 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 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 4,600 people, serving millions of patients across the world. For more information, please visit . References Schuttelaar ML, et al. Effect of delgocitinib cream 20 mg/g on Dermatology Life Quality Index in patients with moderate-to-severe Chronic Hand Eczema: pooled data from the DELTA 1 and DELTA 2 phase 3 trials. 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J Mol Biol. 2017;429(2):208-219. Simpson EL, et al. Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition. Allergy. 2023;78:2875-2891. View source version on businesswire.com: Contacts Melissa Borland LEO Pharma, Senior Manager, Communications - North America Tel: 647-241-1475 Email: MQBCA@leo-pharma.com Source: LEO Pharma A/S View this news release online at: