ArticleBritish journal of pharmacology2015
Preclinical development of AMG 139, a human antibody specifically targeting IL-23.
Article in British journal of pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 31 citations in OpenAlex.
- Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease.BMC gastroenterology · 2023Trial
- HighRes_Builder: improved access and modeling of noncanonical residues for protein structure prediction.Briefings in bioinformatics · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Biologic Case Studies in Monkeys and Humans Reveals the Necessity of an Additional Clearance Term.Pharmaceutics · 2025Article
- [Old and New Biologics and Small Molecules in Inflammatory Bowel Disease: Anti-interleukins].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans.Scientific reports · 2024Article
- Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials.Clinical and experimental gastroenterology · 2023Review
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- Interleukin-23 in the Pathogenesis of Inflammatory Bowel Disease and Implications for Therapeutic Intervention.Journal of Crohn's & colitis · 2022Review
- Preclinical development of a bispecific TNFα/IL-23 neutralising domain antibody as a novel oral treatment for inflammatory bowel disease.Scientific reports · 2021Article
- Increased GM-CSF-producing NCRClinical & translational immunology · 2021Article
- Simple Approach to Accurately Predict Pharmacokinetics of Therapeutic Monoclonal Antibodies after Subcutaneous Injection in Humans.Clinical pharmacokinetics · 2021Article
- Kinetic Exclusion Assay of Biomolecules by Aptamer Capture.Sensors (Basel, Switzerland) · 2020Article
- Functional characterization of the selective pan-allele anti-SIRPα antibody ADU-1805 that blocks the SIRPα-CD47 innate immune checkpoint.Journal for immunotherapy of cancer · 2019Article
- Emerging Therapies for Inflammatory Bowel Disease.Advances in therapy · 2018Review
- Immunological pathogenesis of inflammatory bowel disease.Intestinal research · 2018Review
- Frontiers in Drug Research and Development for Inflammatory Bowel Disease.Frontiers in pharmacology · 2017Review
- The unusual suspects--innate lymphoid cells as novel therapeutic targets in IBD.Nature reviews. Gastroenterology & hepatology · 2015Review
- Article
Corrections and comments
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Authors and funding
20 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeAMG 139 is a human anti-IL-23 antibody currently in a phase II trial for treating Crohn's disease. To support its clinical development in humans, in vitro assays and in vivo studies were conducted in cynomolgus monkeys to determine the pharmacology, preclinical characteristics and safety of this monoclonal antibody. EXPERIMENTAL APPROACH: The in vitro pharmacology, pharmacokinetics (PK), pharmacodynamics and toxicology of AMG 139, after single or weekly i.v. or s.c. administration for up to 26 weeks, were evaluated in cynomolgus monkeys. KEY
resultsAMG 139 bound with high affinity to both human and cynomolgus monkey IL-23 and specifically neutralized the biological activity of IL-23 without binding or blocking IL-12. After a single dose, linear PK with s.c. bioavailability of 81% and mean half-life of 8.4-13 days were observed. After weekly s.c. dosing for 3 or 6 months, AMG 139 exposure increased approximately dose-proportionally from 30 to 300 mg·kg(-1) and mean accumulation between the first and last dose ranged from 2- to 3.5-fold. Peripheral blood immunophenotyping, T-cell-dependent antigen responses and bone formation markers were not different between AMG 139 and vehicle treatment. No adverse clinical signs, effects on body weight, vital signs, ophthalmic parameters, clinical pathology, ECG, organ weights or histopathology were observed in the monkeys with the highest dose of AMG 139 tested (300 mg·kg(-1) s.c. or i.v.). CONCLUSIONS AND IMPLICATIONS: The in vitro pharmacology, PK, immunogenicity and safety characteristics of AMG 139 in cynomolgus monkeys support its continued clinical development for the treatment of various inflammatory diseases.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.