dectrekumab (QAX576) / Novartis - LARVOL DELTA

New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review. (PubMed, Healthcare (Basel)) - "For CeD, therapies like gluten-degrading enzymes (latiglutenase, Kuma030) and zonulin inhibitors (larazotide acetate) show promise, though clinical outcomes are inconsistent...Transglutaminase 2 inhibitors like ZED-1227 could help prevent gluten-induced damage. Monoclonal antibodies targeting immune pathways, such as AMG 714 and larazotide acetate, require further validation in pediatric populations. In EoE, biologics like dupilumab, cendakimab, dectrekumab (IL-13 inhibitors), and mepolizumab, reslizumab, and benralizumab (IL-5/IL-5R inhibitors) show varying efficacy, while thymic stromal lymphopoietin (TSLP) inhibitors like tezepelumab are also being investigated...For IBD, biologics like vedolizumab, ustekinumab, and risankizumab, as well as small molecules like tofacitinib, etrasimod, and upadacitinib, are emerging treatments...Personalized therapy, integrating precision medicine, therapeutic drug monitoring, and lifestyle changes, is increasingly guiding pediatric..."

Journal • Review • Autoimmune Hepatitis • Celiac Disease • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • IL13 • IL5 • TGM2 • TSLP

Off-Label Use of Monoclonal Antibodies for Eosinophilic Esophagitis in Humans: A Scoping Review. (PubMed, Biomedicines) - "Despite the U.S. Food and Drug Administration (FDA) approval of dupilumab for EoE, other monoclonal antibodies remain unapproved and are used off-label with limited evidence on their efficacy and safety...Others like omalizumab (anti-IgE), dectrekumab (anti-IL-13), and reslizumab (anti-IL-5) showed limited utility. Safety evaluations via the FAERS database revealed significant adverse drug reactions, including serious events like asthmatic crises, pneumonia, and adrenal insufficiency for mepolizumab and reslizumab, as well as chronic obstructive pulmonary disease and gastroenteritis for omalizumab...Clinicians should consider the balance between local and systemic effects and exercise caution, closely monitoring for adverse effects, particularly in patients with respiratory comorbidities. Continued research is crucial to establish a more robust evidence base for these therapies."

Journal • Review • Asthma • Chronic Obstructive Pulmonary Disease • Endocrine Disorders • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Nephrology • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • IL13 • IL5

Efficacy and Safety of Monoclonal Antibodies for the Treatment of Eosinophilic Esophagitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Dig Dis Sci) - "MAbs seem effective and safe in reducing esophageal eosinophil infiltrate, EoE-HSS score, EREFS score, and dysphagia symptoms in patients with EoE. However, further evidence is needed to establish its place in EoE management."

Journal • Retrospective data • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL13

The New Therapeutic Frontiers in the Treatment of Eosinophilic Esophagitis: Biological Drugs. (PubMed, Int J Mol Sci) - "Currently, the most relevant is dupilumab, which interferes with both interleukin (IL)-4 and IL-13 pathways by binding IL-4 receptor α, and is the only mAb approved by the European Medicine Agency and US Food and Drug Administration for the treatment of EoE. Other mAbs investigated include mepolizumab, reslizumab, and benralizumab (interfering with IL-5 axis), cendakimab and dectrekumab (anti-IL-13s), tezepelumab (anti-TSLP), lirentelimab (anti-SIGLEG-8), and many others. Despite the undeniable economic impact of biologic therapies, in the near future, there will be room for further reflection about the opportunity to prescribe biologic agents, not only as a last-line therapy in selected cases such as patients with comorbidities involving common pathways. Although recent findings are very encouraging, the road to permanent success in the treatment of EoE is still long, and further studies are needed to determine the long-term effects of mAbs and to discover new potential..."

Journal • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL13 • IL4 • IL5

Current options and investigational drugs for the treatment of eosinophilic esophagitis. (PubMed, Expert Opin Investig Drugs) - "These include monoclonal antibodies (including mepolizumab, reslizumab, benralizumab, dectrekumab, cendakimab, and dupilumab), JAK-STAT blockers and S1PR agonists, among others...Therapies under investigation potentially can target multiple Th2-associated diseases that converge in EoE patients. Therapeutic strategies require a personalized and patient-centered approach to reduce the burden of the disease, and cost-effectiveness analysis to position their use in a complex therapeutic landscape."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

"Eosinophilic Esophagitis Drug Markets, 2028 - Budesonide Oral Suspension, Fluticasone ODT, Mepolizumab, Reslizumab, Benralizumab, Dupilunab, Omalizumab, QAX576, AKOO2, and Losartan - https://t.co/guyiBzPH8C https://t.co/S8GRJErfKm" (@NewsFromBW)

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Novartis: Q3 2013 Results (Novartis) - Anticipated regulatory submission for allergic diseases in 2017 or after

Anticipated regulatory • Immunology

Safety and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis (IPF) (clinicaltrials.gov) - P2, N=40 -> 60; Sponsor: Novartis; Recruiting -> Terminated; Completion date: Oct 2013 -> Mar 2013.

Trial termination • Fibrosis • Immunology

Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2; N=40; Terminated; Sponsor: Novartis Pharmaceuticals; N=60 -> 40

Enrollment change • Biosimilar • Fibrosis • Growth Hormone • Immunology

Efficacy 2 part study of identification of keloid biomarkers and effect of QAX576 on keloid recurrence -

P2, N=3;

Asthma

Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL) (clinicaltrials.gov) - P=N/A; N=22; Recruiting; Sponsor: Memorial Sloan Kettering Cancer Center

New trial • Biosimilar • Breast Cancer • Oncology • Triple Negative Breast Cancer

Novartis: Q4 & FY 2015 Results (Novartis) - Anticipated regulatory submission for allergic diseases in 2020 or later

Anticipated regulatory • Immunology

A Network Meta-Analysis of Randomized Controlled Trials on the Treatment of Eosinophilic Esophagitis in Adults and Children. (PubMed, J Clin Gastroenterol) - "This meta-analysis showed that budesonide 1 mg orodispersible tablet twice daily was the best treatment for EoE, as it was the most effective. This treatment remained the optimal approach in adult patients, whereas fluticasone was the best treatment in pediatric patients."

Journal • Retrospective data • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Pediatrics • IL13 • IL5

Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review. (PubMed, Drugs) - "Additionally, anti-allergic targets, immunosuppressives, and monoclonal antibodies (such as mepolizumab, reslizumab, QAX576, RPC4046, dupilumab, omalizumab, and infliximab) that have been evaluated as treatments for EoE are summarized. Finally, several promising therapeutic agents (e.g., sialic acid-binding immunoglobulin-like lectin 8 antibodies, the transforming growth factor-β1 signal blocker losartan, CC chemokine receptor type 3 antagonists, thymic stromal lymphopoietin antibodies, antibodies targeting the α4β7 integrin, anti-interleukin-9 antibodies, and anti-interleukin-15 antibodies) that target specific molecules or cells implicated in the pathogenesis of EoE are proposed."

Journal • Review

Pharmacological treatments for eosinophilic esophagitis: current options and emerging therapies. (PubMed, Expert Rev Clin Immunol) - "Refractoriness, high recurrence rates and need for long-term therapies has promoted the investigation of novel, esophageal-targeted formulas of topic corticosteroids, and monoclonal antibodies (including mepolizumab, reslizumab, QAX576, RPC4046, dupilumab, omalizumab, infliximab and vedolizumab) for EoE, with some having been demonstrated as effective and safe in the short term. Several additional promising therapies are also discussed.Expert opinion: Several therapeutic targets have shown efficacy and will be approved to treat EoE, especially corticosteroid-sparing options and those for patients with multiple Th2-associated diseases. Personalized therapeutic strategies for initial and maintenance treatments of EoE must be rationally designed, to reduce the burden of disease and answer meaningfully the needs of all stakeholders involved in EoE."

Journal