trabikibart (CSL311) / CSL Behring - LARVOL DELTA

Signalling via CD131 regulates pulmonary inflammation, alveolar cell death and emphysema in COPD. (PubMed, ERJ Open Res) - "To model emphysema, transgenic mice expressing human CD131 were exposed to elastase or cigarette smoke (CS) and a fully human monoclonal antibody (CSL311) was employed to inhibit CD131 signalling...CD131 signalling orchestrates pulmonary inflammation in COPD, resulting in immunopathology that underpins emphysema and lung function decline. Antagonising CD131 therefore represents a unique strategy to simultaneously target multiple pathogenic myeloid cell populations."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • ELANE

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: CSL Behring | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Dual inhibition of airway inflammation and fibrosis by common beta cytokine receptor blockade. (PubMed, J Allergy Clin Immunol) - "βc cytokines drive steroid-resistant mixed myeloid cell airway inflammation and fibrosis. The anti-βc antibody CSL311 effectively inhibits mixed T2/neutrophilic inflammation and severe asthma-like pathology and reverses fibrosis gene signatures induced by exposure to commonly encountered environmental allergens."

Journal • Asthma • Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CSF2 • IL5

Evaluating CD131 as a potential target for reducing inflammation in chronic airway disease (EAACI 2023) - "The βc-cytokines were able to activate these effectors, which blockade of CD131 with CSL311 could inhibit. Inhibition of βc cytokine-induced activation, proliferation and cellular migration may provide a therapeutic benefit in airway inflammation."

Late-breaking abstract • Immunology • Inflammation • CR1 • IL5 • ITGAM • SELL

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: CSL Behring | Trial completion date: Jan 2024 ➔ Oct 2023 | Trial primary completion date: Jan 2024 ➔ Oct 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Targeting the human β receptor inhibits inflammatory myeloid cells and lung injury caused by acute cigarette smoke exposure. (PubMed, Respirology) - "This study identifies CSL311 as a therapeutic antibody that potently inhibits immunopathology and lung injury caused by acute CS exposure."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL17A • IL5 • ITGAM

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: CSL Behring | Active, not recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=114 | Active, not recruiting | Sponsor: CSL Behring | Trial completion date: Jun 2023 ➔ Jan 2024 | Trial primary completion date: Jun 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Blocking the human common beta subunit of the GM-CSF, IL-5 and IL-3 receptors markedly reduces hyperinflammation in ARDS models. (PubMed, Cell Death Dis) - "Furthermore, CSL311 treatment did not limit the viral-induced expansion of NK and NKT cells, or the tissue expression of type I/II/III interferons needed for efficient viral clearance. Simultaneously blocking GM-CSF, IL-5 and IL-3 signalling with CSL311 may represent an improved and clinically applicable strategy to reducing hyperinflammation in the ARDS setting."

Journal • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • CSF2 • IL5

Targeting the human β receptor inhibits contact dermatitis in a transgenic mouse model. (PubMed, J Invest Dermatol) - "Importantly, the blocking anti-human β antibody CSL311 strongly suppressed ear pinna thickening and histopathological changes typical of ACD and reduced accumulation of neutrophils, mast cells and eosinophils in the skin. These results show that GM-CSF and IL-5, but not IL-3 are major mediators of ACD and define the hβTg mouse as a unique platform to test inhibitors of βin vivo."

Journal • Preclinical • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CSF2 • IL5

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Active, not recruiting; Sponsor: CSL Behring; Recruiting ➔ Active, not recruiting; Trial completion date: May 2022 ➔ Jun 2023; Trial primary completion date: May 2022 ➔ Jun 2023

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; Trial completion date: Oct 2022 ➔ May 2022; Trial primary completion date: Oct 2022 ➔ May 2022

Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; Trial completion date: May 2022 ➔ Oct 2022; Trial primary completion date: May 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; N=82 ➔ 114; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ May 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: CSL Behring; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Asthma • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=82; Active, not recruiting; Sponsor: CSL Behring; Trial completion date: Apr 2021 ➔ Nov 2021; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Asthma • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Active, not recruiting; Sponsor: CSL Behring; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: CSL Behring; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Anti-β mAb CSL311 inhibits human nasal polyp pathophysiology in a humanized mouse xenograft model. (PubMed, Allergy) - No abstract available.

Journal • Preclinical

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL31 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Not yet recruiting; Sponsor: CSL Behring

Clinical • New P1 trial