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Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: A randomised, placebo-controlled, crossover phase 2a study

Morice, Alyn; Smith, Jaclyn A.; McGarvey, Lorcan; Birring, Surinder S.; Parker, Sean M.; Turner, Alice; Hummel, Thomas; Gashaw, Isabella; Fels, Lueder; Klein, Stefan; Francke, Klaus; Friedrich, Christian

Authors

Jaclyn A. Smith

Lorcan McGarvey

Surinder S. Birring

Sean M. Parker

Alice Turner

Thomas Hummel

Isabella Gashaw

Lueder Fels

Stefan Klein

Klaus Francke

Christian Friedrich



Abstract

Background. ATP acting via P2X3 receptors is an important mediator of refractory chronic cough (RCC). This phase 2a double-blinded crossover study assessed the safety, tolerability and efficacy of eliapixant (BAY 1817080), a selective P2X3 receptor antagonist, in adults with RCC attending specialist centres.
Methods. In period A, patients received placebo for 2 weeks then eliapixant 10 mg for 1 week. In period B, patients received eliapixant 50, 200 and 750 mg twice daily for 1 week per dose level. Patients were randomised 1:1 to period A–B (n=20) or B–A (n=20). The primary efficacy end-point was change in cough frequency assessed over 24 h. The primary safety end-point was frequency and severity of adverse events (AEs).
Results. 37 patients completed randomised therapy. Mean cough frequency fell by 17.4% versus baseline with placebo. Eliapixant reduced cough frequency at doses ≥50 mg (reduction versus placebo at 750 mg: 25% (90% CI 11.5–36.5%); p=0.002). Doses ≥50 mg also significantly reduced cough severity. AEs, mostly mild or moderate, were reported in 65% of patients with placebo and 41–49% receiving eliapixant. Cumulative rates of taste-related AEs were 3% with placebo and 5–21% with eliapixant; all were mild.
Conclusions. Selective P2X3 antagonism with eliapixant significantly reduced cough frequency and severity, confirming this as a viable therapeutic pathway for RCC. Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant. Selective P2X3 antagonism appears to be a novel therapeutic approach for RCC.

Citation

Morice, A., Smith, J. A., McGarvey, L., Birring, S. S., Parker, S. M., Turner, A., …Friedrich, C. (2021). Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: A randomised, placebo-controlled, crossover phase 2a study. European respiratory journal, 58(5), Article 2004240. https://doi.org/10.1183/13993003.04240-2020

Journal Article Type Article
Acceptance Date Apr 5, 2022
Online Publication Date May 13, 2021
Publication Date Nov 1, 2021
Deposit Date May 12, 2022
Publicly Available Date Mar 28, 2024
Journal European Respiratory Journal
Print ISSN 0903-1936
Electronic ISSN 1399-3003
Publisher European Respiratory Society
Peer Reviewed Peer Reviewed
Volume 58
Issue 5
Article Number 2004240
DOI https://doi.org/10.1183/13993003.04240-2020
Keywords Pulmonary and Respiratory Medicine
Public URL https://hull-repository.worktribe.com/output/3769235

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