ecleralimab (CSJ117) / Novartis - LARVOL DELTA

Investigational thymic stromal lymphopoietin inhibitors for the treatment of asthma: a systematic review. (PubMed, Expert Opin Investig Drugs) - "Currently, the only TSLP inhibitor approved for the treatment of severe asthma is the immunoglobulin G (IgG) 2λ anti-TSLP monoclonal antibody (mAb) tezepelumab...Ecleralimab, an inhaled antibody fragment antigen binding, shows promising evidence in enhancing efficacy and reducing systemic adverse events. SAR443765, with its NANOBODY® formulation and bispecific inhibition of TSLP and IL-13, offers improved tissue penetration and efficacy. The mAB TQC2731 exhibits high in vitro bioactivity, and the strength of the mAb UPB-101 is to act against the TSLP receptor...This systematic review highlights the potential of TSLP inhibitors as valuable additions to asthma treatment, even in milder forms of the disease. Future research and cost-reduction efforts are needed to expanding access to these promising therapies."

Journal • Review • Stroma • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL13 • TSLP

Inhaled anti-TSLP antibody fragment, ecleralimab, blocks responses to allergen in mild asthma. (PubMed, Eur Respir J) - "Ecleralimab significantly attenuated allergen-induced bronchoconstriction and airway inflammation and was safe in subjects with mild atopic asthma."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

Development of an inhaled anti-TSLP therapy for asthma. (PubMed, Pulm Pharmacol Ther) - "TSLP plays a role in asthma pathogenesis as an upstream cytokine, and data suggest that TSLP blockade with the anti-TSLP monoclonal antibody, tezepelumab, could be efficacious in a broad asthma population. A Phase IIa proof of concept study, using allergen bronchoprovocation as a model for asthma exacerbations, found that ecleralimab was well-tolerated and reduced allergen-induced bronchoconstriction in adult patients with mild asthma. These results suggest ecleralimab may be a promising, new therapeutic class for asthma treatment."

Journal • Review • Asthma • Eosinophilia • Hematological Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2

"The article is from 2020. The committee hearings to strengthen the #CanadaDisabilityBenefit #cdb #pwd are happening now with two remaining dates for letters and presentations on Nov14&16 Huma committee on Parlvu website C-22, link through Google." (@Gail_Nestel)

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed | N=300 ➔ 38 | Trial completion date: Aug 2023 ➔ Sep 2022 | Trial primary completion date: Aug 2023 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=136 | Terminated | Sponsor: Novartis Pharmaceuticals | N=325 ➔ 136 | Recruiting ➔ Terminated; Sponsor Decision

Enrollment change • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=336 | Terminated | Sponsor: Novartis Pharmaceuticals | N=625 ➔ 336 | Trial completion date: Feb 2024 ➔ Sep 2022 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2023 ➔ Jul 2022; Sponsor Desicion

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"$NVS's CSJ117 has the same MoA as $AMGN & $AZN's Tezspire, approved for severe asthma in Dec 2021 - analysts had hoped for a mod-to-severe label & expectations have come down" (@ByMadeleineA)

Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"$NVS CSJ117, Keymed's CM326 & Biosion's BSI045B are apparently the only anti-TSLP MAbs challenging $AMGN $AZN tezepelumab https://t.co/JEDcieq56y" (@JacobPlieth)

"$NVS is also seeking to partner out CPK850 (RLBP 1 gene therapy for retinitis pigmentosa) & CSJ117 (anti-TSLP MAb for asthma)" (@JacobPlieth)

Asthma • Gene Therapies • Genetic Disorders • Immunology • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinitis Pigmentosa

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2024 ➔ Sep 2022 | Trial primary completion date: May 2024 ➔ Jul 2022

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

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2023 ➔ Aug 2024 | Trial primary completion date: Mar 2023 ➔ May 2024

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

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=625 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2022 ➔ Feb 2024 | Trial primary completion date: Sep 2022 ➔ Nov 2023

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

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Oct 2022 ➔ Jun 2023; Trial primary completion date: Jul 2022 ➔ Mar 2023

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

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=625; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Apr 2022 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Sep 2022

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

Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD (clinicaltrialsregister.eu) - P2; N=300; Ongoing; Sponsor: Novartis Pharma AG

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthma (clinicaltrialsregister.eu) - P2; N=375; Ongoing; Sponsor: Novartis Pharma AG

Clinical • New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

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

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: May 2023 ➔ Aug 2023; Trial primary completion date: May 2023 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma (clinicaltrials.gov) - P2; N=325; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] The Sputum Transcriptome of Mild Atopic Asthma Following Bronchoprovocation and Inhaled Anti-TSLP Antibody Fragment Treatment (ATS 2021) - "Our optimized sputum processing and RNA extraction protocols resulted in high quality transcriptome data allowing for molecular assessment of the allergen-induced changes in sputum confirming the utility of bronchoprovocation model in mild asthma. The results further our understanding of CSJ117 effect on Th2 pathway in mild atopic asthma patients. These data substantiates the anticipated mode of action of CSJ117 at the molecular level."

Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL5 • TSLP

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Research status and prospects of TSLP inhibitors in the treatment of asthma [Google translation] (med.china.com.cn) - "The TSLP target drugs that have entered the clinical stage are only a few biological drugs, such as the fully human IgG2λ monoclonal antibody Tezepelumab...and the inhalation developed jointly by Novartis and MorphoSys Dosage type—Immunoglobulin G1/λ subtype antibody fragment CSJ-117...and other recombinant humanized IgG1 monoclonal antibodies such as Merck MK-8226, Roche RG7258, Astellas ASP7266....Bifunctional drugs...provide an exciting new method for the treatment of asthma....The monovalent bispecific antibody Zweimab and the bivalent bispecific antibody Doppelmab, which are used to target TSLP and IL-13 due to the huge overlap of signal pathways, have been designed, developed and characterized."

Review • Asthma • Respiratory Diseases

Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthma A CSJ117 hatásosságának és biztonságosságának vizsgálata súlyos, nem kontrollált asztmában szenvedő betegek körében (clinicaltrialsregister.eu) - P2; N=625; Ongoing; Sponsor: Novartis Pharma AG

Clinical • New P2 trial • Asthma • Immunology • Respiratory Diseases