eblasakimab (ASLAN004) / ASLAN Pharma, Zenyaku Holdings - LARVOL DELTA

Factors influencing the decision over systemic therapy and goals of therapy for atopic dermatitis (EADV 2025) - " Current guidelines and systematic reviews support the safety and efficacy of systemic therapy including conventional drugs (cyclosporine, methotrexate, and azathioprine), biologics (dupilumab and tralokinumab), and JAK inhibitors (baricitinib, upadacitinib, and abrocitinib) recommended for treating moderate and severe AD. Recently, additional biologics have been evaluated in clinical trials, including lebrikizumab, nemolizumab, eblasakimab, and OX40/OX40L, among others.Thus, AD patient management and decisions regarding advanced/systemic therapy are complex-requiring the consideration of multiple disease-related factors: disease severity, patient medical history and comorbidities, previous topical therapy use, patient preferences, expectations and fears, pregnancy planning, impact on related risks and any associated psychological or psychiatric issues. Available data indicate the importance of a personalized, stepwise, and multidisciplinary approach which promotes..."

Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Psychiatry • Suicidal Ideation • TNFSF4

Atopic Dermatitis-Related Problems in Daily Life, Goals of Therapy and Deciding Factors for Systemic Therapy: A Review. (PubMed, Pharmaceuticals (Basel)) - "Current guidelines and systematic reviews support the safety and efficacy of systemic therapy including conventional drugs (cyclosporine, methotrexate, and azathioprine), biologics (dupilumab and tralokinumab), and JAK inhibitors (baricitinib, upadacitinib, and abrocitinib) recommended for treating moderate and severe AD. Recently, additional biologics have been evaluated in clinical trials, including lebrikizumab, nemolizumab, eblasakimab, and OX40/OX40L, among others...Available data also indicate the importance of a personalized, stepwise, and multidisciplinary approach. This type of approach promotes patient compliance, satisfaction with therapy, and increased engagement, which all lead to better patient outcomes."

Journal • Review • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Mood Disorders • Psychiatry • Suicidal Ideation • TNFSF4

IL-13 inhibition in the treatment of atopic dermatitis - new and emerging biologic agents. (PubMed, J Int Med Res) - "Tralokinumab is approved for use in Europe and the USA, while lebrikizumab is approved only in Europe. Cendakimab, which is another IL-13 selective inhibitor, has shown promising results in phase II trials, providing safe and effective outcomes. Eblasakimab, which disrupts IL-13 and IL-4 signaling pathways, is currently in phase II trials following well-tolerated administration in phase I studies. This narrative review aims to outline the current state of knowledge regarding the effectiveness and safety of these four biologic agents targeting IL-13 signaling."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL4

Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate‑to‑Severe Atopic Dermatitis. (PubMed, BioDrugs) - P1 | "The effect of eblasakimab on circulating AD‑associated biomarker levels was accompanied by improvements in signs and symptoms of AD, consistent with the inhibition of IL-13 and IL-4 signaling via the type 2 receptor."

Biomarker • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL4

Eblasakimab Significantly Alleviates IL-4 and IL-13-induced Bronchial Airway Constriction in COPD-Derived Lung Slices (ATS 2024) - "Eblasakimab significantly reduced IL-13- and IL-4-induced bronchial airway constriction and significantly reduced sensitization by the constricting agent methacholine. This suggests a direct functional role of eblasakimab on airway hyper-responsiveness and a reduction of the pro-inflammatory-induced airway constriction responses driven by IL-4/IL-13. Our head-to-head studies of eblasakimab against dupilumab underline that eblasakimab may provide potentially stronger relief to address bronchoconstriction and improve dilatory function in COPD, and possibly in other Th2-driven lung disorders."

Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4

ASLAN Pharmaceuticals Presents Late-Breaking Translational Data on Eblasakimab in COPD at the American Thoracic Society International Conference (GlobeNewswire) - "ASLAN Pharmaceuticals...announced the late-breaking poster presentation of translational data from head-to-head studies of eblasakimab and dupilumab in human healthy and COPD-derived lung tissue models at the American Thoracic Society (ATS) International Conference 2024 in San Diego, California....In both healthy and COPD-derived lung tissues, eblasakimab significantly reduced IL-4- and IL-13-induced bronchial airway constriction. In IL-4 and IL-13 pre-treated healthy lung tissues, eblasakimab further restored formoterol-induced airway dilation, significantly better than dupilumab at the lower concentration, and improved methacholine-induced constriction. The results suggest eblasakimab may provide a therapeutic benefit in reducing IL-4- and IL-13-induced airway hyperresponsiveness and that eblasakimab may provide relief in situations of acute airway constriction."

Clinical data • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ASLAN Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Anticipated upcoming milestones...Selection of a development partner to advance eblasakimab into Phase 3 testing in AD and other indications....Cash used in operations for the first quarter of 2024 was $7.4 million compared to $19.3 million for the same period in 2023. The decrease was due to lower clinical development and manufacturing costs for eblasakimab studies following the TREK-AD topline data readout in July 2023; Research and development expenses were $5.9 million for the first quarter of 2024 compared to $14.1 million for the first quarter of 2023. The decrease was due to lower clinical development and manufacturing costs for eblasakimab studies following the TREK-AD topline data readout."

Commercial • Atopic Dermatitis • Dermatitis • Immunology

ASLAN Pharmaceuticals to Present Additional Data From Interim Analysis of TREK-DX Phase 2 Study of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients During Virtual KOL Event (GlobeNewswire) - P2b | N=302 | NCT05158023 | Sponsor: ASLAN Pharmaceuticals | "ASLAN Pharmaceuticals...will today host a virtual KOL event, during which Company management will present new data from the interim analysis of the Phase 2 TREK-DX study of eblasakimab in dupilumab-experienced atopic dermatitis (AD) patients....The primary endpoint, which is the percent change in Eczema Area Severity Index (EASI) score from baseline to Week 16, was statistically significant when compared to placebo (p=0.0059), even though the interim analysis was not powered for statistical significance due to the sample size. 60.0% of dupilumab-experienced AD patients treated with 400mg eblasakimab weekly achieved EASI-90 (at least a 90% reduction in their EASI score) and 66.7% achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks, versus 14.3% of patients on placebo."

P2b data • Atopic Dermatitis • Immunology

ASLAN Pharmaceuticals Announces Expansion of its Collaboration With Zenyaku to Investigate the Biology Underlying Differential Effects of Eblasakimab Compared to Other Biologics (GlobeNewswire) - "ASLAN Pharmaceuticals...announced that it has signed a new research collaboration agreement with its partner, Zenyaku Kogyo Co., Ltd. (Zenyaku), to establish a framework for a succession of research projects to explore the differentiation of eblasakimab’s mechanism of action versus biologic therapies for atopic dermatitis (AD), dupilumab and lebrikizumab...The results from this research collaboration will provide further insight into the differentiated receptor biology of targeting IL-13R versus IL-4R....This new agreement expands upon the commercial agreement that ASLAN signed with Zenyaku in June 2023 for the development and commercialization of eblasakimab in Japan."

Licensing / partnership • Atopic Dermatitis • Immunology

ASLAN Pharmaceuticals to Host KOL Panel Discussion on Treatment Options for Atopic Dermatitis Patients With an Inadequate Response to Dupilumab (GlobeNewswire) - "ASLAN Pharmaceuticals...announced that it will host a virtual Key Opinion Leader (KOL) Event...to be held on Tuesday, May 7, 2024 from 8:00 AM ET to 9:00 AM ET. The event will feature a discussion with Lisa Beck, MD from University of Rochester, Peter Lio, MD from Northwestern University, and Raj Chovatiya, MD, PhD from Rosalind Franklin University Chicago Medical School, moderated by Seth Orlow, MD, PhD from New York University, on the recently announced positive interim results from ASLAN’s Phase 2 TREK-DX study of eblasakimab, a potential first-in-class biologic candidate, in patients with moderate-to-severe atopic dermatitis (AD) that had previously been treated with dupilumab. Panelists will discuss this growing new market and the treatment options available to patients with an inadequate response to dupilumab. Company management will also present new data from the interim analysis of the TREK-DX study."

P2 data • Atopic Dermatitis • Immunology

ASLAN004-003: Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=302 | Completed | Sponsor: ASLAN Pharmaceuticals | Phase classification: P2b ➔ P2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ASLAN Pharmaceuticals Announces Late Breaking Abstract on Eblasakimab in COPD Accepted for Presentation at the American Thoracic Society International Conference (GlobeNewswire) - "ASLAN Pharmaceuticals...announced that an abstract on eblasakimab in Chronic Obstructive Pulmonary Disease has been accepted for a late breaking poster presentation at the American Thoracic Society International Conference 2024. The conference is taking place in San Diego, California, from May 17 to 22, 2024."

Clinical data • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ASLAN Pharmaceuticals Announces Positive Interim Results From Phase 2 Study of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients (GlobeNewswire) - P2 | N=302 | TREK-DX (NCT05158023) | Sponsor: ASLAN Pharmaceuticals | "ASLAN Pharmaceuticals...announced positive interim results from the Phase 2 study of eblasakimab in moderate-to-severe atopic dermatitis (AD) adult patients previously treated with dupilumab, TREK-DX. The primary endpoint, which is the percent change in Eczema Area Severity Index (EASI) score from baseline to week 16, was statistically significant when compared to placebo (p=0.0059), even though the interim analysis was not powered for statistical significance due to the sample size. 73.3% (11/15) of eblasakimab-treated patients achieved a reduction in EASI score of at least 75% from baseline (EASI-75) compared to 14.3% (1/7) on placebo (p=0.0431)....The interim data will be submitted for presentation at an upcoming scientific conference."

P2 data • Atopic Dermatitis • Immunology

ASLAN Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Presentation of positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of COPD at an upcoming scientific congress in Q2 2024."

Preclinical • Chronic Obstructive Pulmonary Disease

ASLAN Pharmaceuticals Provides TREK-DX Study Update and Highlights Potential of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients (GlobeNewswire) - P2 | N=302 | TREK-DX (NCT05158023) | Sponsor: ASLAN Pharmaceuticals | "ASLAN Pharmaceuticals Ltd...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)....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....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....Topline unblinded data from the full dataset is expected at the end of 2024."

Enrollment status • P2 data • Trial status • Atopic Dermatitis • Immunology

ASLAN Pharmaceuticals Announces New Translational Data on Eblasakimab in COPD and Appoints Leading Respiratory Experts as Scientific Advisors (GlobeNewswire) - "ASLAN Pharmaceuticals Ltd...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 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."

Preclinical • Atopic Dermatitis • Immunology

Efficacy and safety of eblasakimab in adults with severe atopic dermatitis: a posthoc analysis of the Phase 2b TREK-AD trial (AAD 2024) - P2b | "Extending results in moderate-to-severe AD, eblasakimab also demonstrated compelling efficacy with an excellent safety profile in severe AD, with monthly dosing from initiation comparable to dosing every two weeks, while placebo responses dropped in this group."

Clinical • P2b data • Retrospective data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13 • IL4

Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: ASLAN Pharmaceuticals | Trial completion date: Dec 2023 ➔ Feb 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ASLAN Pharmaceuticals Provides Year-End Update on Its Eblasakimab and Farudodstat Programs (GlobeNewswire) - "Based on findings from the TREK-AD study, which highlighted the changing patient population in the US, the TREK-DX inclusion criteria have been modified to enroll patients with an EASI score of at least 18 and independent reviewer confirmation of baseline EASI scores has been implemented. US sites are now recruiting according to the updated criteria and additional sites in Europe are expected to open in the first half of 2024. ASLAN will provide an update in early 2024 on the timing of the expected topline readout from the study in 2024."

P2 data • Atopic Dermatitis • Immunology

Neuromodulation beyond itch is blocked by targeting IL-13Rα1 with eblasakimab (ISDS 2023) - "They also demonstrate the ability of eblasakimab to block these cytokine-mediated effects. Together, these data provide a mechanistic basis for the reduction of itch observed in moderate-to-severe AD patients treated with eblasakimab in a phase 1b clinical trial."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4

Downstream effects of IL-13Rα1 blockade on Th2-driven inflammation and Th1 immune axis activation in atopic dermatitis (ISDS 2023) - "These results suggest that targeting different subunits of the same molecular pathway can lead to different downstream effects and subsequent expression of Th1- and Th2-associated cytokines. Eblasakimab may offer a differentiated therapeutic approach to treat moderate to severe AD with the potential to spare the Type 1 receptor and the effects seen with targeting IL-4Rα."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Oncology • CSF2 • IL13 • IL2 • IL4 • TNFA

ASLAN Pharmaceuticals Presents New Data on Eblasakimab in Atopic Dermatitis and COPD Translational Models at the 7th Dermatology Drug Development Summit (GlobeNewswire) - "ASLAN Pharmaceuticals...today announced new data was presented at the Dermatology Drug Development Summit (DDDS) that took place in Boston, MA, from October 31 to November 2, 2023....A head-to-head study between eblasakimab and dupilumab conducted in skin punch biopsies of AD patients showed differential expression of inflammatory cytokines secreted by the localized skin tissue, with eblasakimab treatment more efficiently reducing expression of Th2 cytokines IL-13, IL-4 and sCD40L, as well as IL-17F and chemokines CCL3 and CCL4, compared to dupilumab treatment....Eblasakimab significantly reduced IL-4 and IL-13-induced AHR by reducing airway constriction. Furthermore, IL-4 and IL-13 sensitized the airways to further constriction in response to methacholine, but this sensitization was blocked by eblasakimab treatment."

Preclinical • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ASLAN Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update (Yahoo Finance) - "Presentation of preliminary results on eblasakimab in a human translational model of chronic obstructive pulmonary disorder (COPD) at the 7th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases on 2 November....A Phase 1 trial of eblasakimab in Japan is expected to be initiated by ASLAN’s partner, Zenyaku Kogyo Co,. in the first half of 2024....Research and development expenses were $7.2 million in the third quarter of 2023 compared to $8.0 million in the third quarter of 2022. The decrease was due to lower clinical development and manufacturing costs for the eblasakimab studies following the TREK-AD topline data readout."

Commercial • New P1 trial • Preclinical • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Safety and efficacy of eblasakimab, an IL-13Rα1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: a phase 1b, multiple-ascending dose study. (PubMed, J Am Acad Dermatol) - "Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements vs. placebo."

Clinical • Journal • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IL13 • IL4

ASLAN Pharmaceuticals to Co-Host KOL Panel Discussion Today on Changes in the Clinical Trial and Treatment Landscape for Atopic Dermatitis (GlobeNewswire) - "ASLAN Pharmaceuticals...announced that it will co-host a virtual investor event today with a leading Clinical Research Organization (CRO)...at 11:00am – 12:00pm ET....During the event, ASLAN will present additional analyses of the TREK-AD patient population building on data recently published at the 32nd European Academy of Dermatology and Venereology (EADV) Congress....Based on these learnings from TREK-AD, ASLAN plans to implement changes to the ongoing phase 2b TREK-DX study of eblasakimab in dupilumab-experienced, moderate-to-severe AD patients. In addition to recruiting patients in the US, ASLAN will open new sites in Europe, introduce independent reviewer confirmation of the severity of the disease, and tighten the inclusion criteria to enroll patients with a baseline Eczema Area and Severity Index (EASI) score of at least 18. ASLAN will provide updated guidance on the timing for the topline readout..."

Clinical data • P2b data • Atopic Dermatitis • Immunology