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

Alyn Morice, 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
European Respiratory Journal 2021; DOI: 10.1183/13993003.04240-2020
Alyn Morice
1Respiratory Research Group, Hull York Medical School, University of Hull, Hull, UK
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  • For correspondence: a.h.morice@hull.ac.uk
Jaclyn A. Smith
2Manchester University NHS Foundation Trust, and Manchester Academic Health Science Centre, Manchester, UK
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Lorcan McGarvey
3Wellcome Wolfson Institute of Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK
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Surinder S. Birring
4Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College Hospital, London, UK
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Sean M. Parker
5North Tyneside Hospital, Northumbria Healthcare NHS Foundation Trust, North Shields, UK
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Alice Turner
6Institute of Applied Health Research and Population Sciences, University of Birmingham, Birmingham, UK
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Thomas Hummel
7Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany
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Isabella Gashaw
8Bayer AG, Berlin, Germany
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Lueder Fels
8Bayer AG, Berlin, Germany
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Stefan Klein
8Bayer AG, Berlin, Germany
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Klaus Francke
8Bayer AG, Berlin, Germany
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Christian Friedrich
8Bayer AG, Berlin, Germany
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Abstract

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.

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 endpoint was change in cough frequency assessed over 24 h (VitaloJAK). Primary safety endpoint was frequency and severity of adverse events (AEs).

Thirty-seven 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% confidence interval, 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.

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.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

Conflict of interest: Dr Morice reports grants, personal fees, non-financial support and other from Bayer AG, grants, personal fees, non-financial support and other from Bayer US, during the course of the study; personal fees, non-financial support and other from Bellus Health, personal fees, non-financial support and other from Merck Sharp & Dohme Corp, personal fees and non-financial support from AstraZeneca, grants, personal fees, non-financial support and other from Sanofi, personal fees and non-financial support from Chiesi Ltd, grants, personal fees and non-financial support from GlaxoSmithKline, personal fees and non-financial support from Boehringer Ingelheim, grants, personal fees and other from NeRRe Therapeutics, grants, personal fees and non-financial support from Respivant Sciences, Inc, grants, personal fees and non-financial support from Philips Respironics, grants from Menio Therapeutics, outside the submitted work.

Conflict of interest: Dr Smith reports grants and personal fees from Bayer AG, during the course of the study; grants and personal fees from Bellus Health, grants and personal fees from Shionogi Inc, grants and personal fees from Merck Inc, outside the submitted work; and the VitaloJAK algorithm has been licensed by Manchester University NHS Foundation Trust and the University of Manchester to Vitalograph Ltd and Vitalograph Ireland (Ltd). Manchester University NHS Foundation Trust receives royalties which may be shared with the clinical division in which Jaclyn Smith works.

Conflict of interest: Dr McGarvey reports grants and personal fees from Bayer AG, during the conduct of the study; grants and personal fees from Merck & Co., Inc., grants, personal fees and non-financial support from Chiesi, grants and personal fees from Bellus Health, non-financial support from Boehringer Ingelheim, personal fees from Applied Clinical Intelligence, personal fees from Shionogi Inc., personal fees from GlaxoSmithKline, personal fees from NeRRe Therapeutics, from Nocion Therapeutics, other from AstraZeneca, outside the submitted work.

Conflict of interest: Dr Birring reports personal fees from Bayer, grants and personal fees from Merck, personal fees from Shionogi, personal fees from Bellus Health, personal fees from NeRRe Therapeutics, personal fees from Nocio, personal fees from Boehringer Ingelheim, personal fees from GlaxoSmithKline, outside the submitted work.

Conflict of interest: Dr Parker reports personal fees from Menlo, personal fees from Merck, outside the submitted work.

Conflict of interest: Dr Turner has nothing to disclose.

Conflict of interest: Dr Hummel reports grants from Sony (Stuttgart, Germany), grants from Smell and Taste Lab (Geneva, Switzerland), grants from Takasago (Paris, France), grants from aspuraclip (Berlin, Germany), personal fees from Frequency Therapeutics (Farmington, CT, USA), personal fees from Baiafoods (Madrid, Spain), outside the submitted work.

Conflict of interest: Dr Gashaw reports other from Bayer AG, during the conduct of the study.

Conflict of interest: Dr Fels reports personal fees from Bayer AG, during the conduct of the study.

Conflict of interest: Dr Klein reports personal fees from Bayer AG, during the conduct of the study.

Conflict of interest: Dr Franke reports personal fees from Bayer AG, during the conduct of the study.

Conflict of interest: Dr Friedrich reports personal fees from Bayer AG, during the conduct of the study.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received November 17, 2020.
  • Accepted April 5, 2021.
  • Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org
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Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study
Alyn Morice, 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
European Respiratory Journal Jan 2021, 2004240; DOI: 10.1183/13993003.04240-2020

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Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study
Alyn Morice, 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
European Respiratory Journal Jan 2021, 2004240; DOI: 10.1183/13993003.04240-2020
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