tezepelumab

Home
Ligands
tezepelumab

GtoPdb Ligand ID: 8933

tezepelumab is an approved drug (FDA (2021), ENA (2022))

Comment: Tezepelumab is a fully human IgG2λ monoclonal antibody, that is a potential first-in-class agent that blocks the epithelial-cell-derived cytokine thymic stromal lymphopoietin (TSLP- which is an upstream modulator of multiple inflammatory pathways). It is being investigated for its immunomodulatory action.

No information available.

No information available.

Summary of Clinical Use
Evauation of tezepelumab was continued in patients with severe asthma, but it failed to demonstrate efficacy in atopic dermatitis [1]. Tezepelumab was granted breakthrough designation by the FDA in September 2018 based on data from the Phase 2b PATHWAY study. Click here to link to ClinicalTrials.gov's full listing of tezepelumab (research coded AMG 157 or MEDI9929) trials. The FDA granted full approval as a therapeutic option for severe asthma in December 2021.

Summary of Clinical Use

Evauation of tezepelumab was continued in patients with severe asthma, but it failed to demonstrate efficacy in atopic dermatitis [1]. Tezepelumab was granted breakthrough designation by the FDA in September 2018 based on data from the Phase 2b PATHWAY study. Click here to link to ClinicalTrials.gov's full listing of tezepelumab (research coded AMG 157 or MEDI9929) trials. The FDA granted full approval as a therapeutic option for severe asthma in December 2021.

Mechanism Of Action and Pharmacodynamic Effects
TSLP is a cytokine predominantly secreted by epithelial cells. TSLP plays a role in allergic inflammation [6-7] and levels of this cytokine correlate with severity of disease symptoms in atopic dermatitis and asthma [9]. Tezepelumab functionally antagonises the action of TSLP at its receptor [3], thereby reducing its pro-inflammatory activity.

Mechanism Of Action and Pharmacodynamic Effects

TSLP is a cytokine predominantly secreted by epithelial cells. TSLP plays a role in allergic inflammation [6-7] and levels of this cytokine correlate with severity of disease symptoms in atopic dermatitis and asthma [9]. Tezepelumab functionally antagonises the action of TSLP at its receptor [3], thereby reducing its pro-inflammatory activity.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT03706079	Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma	Phase 3 Interventional	AstraZeneca	NCT03706079 (DESTINATION) is a long-term extension of the NAVIGATOR (NCT03347279) and SOURCE (NCT03406078) trials of tezepelumab in asthma patients. A press release from Amgen and AstraZeneca in early November reported that the study met its primary endpoint in patients with severe asthma. Full results are yet to be published in a peer-reviewed article.	4-5,8