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Late Breaking Abstract - The neurokinin-1 receptor antagonist orvepitant improves chronic cough symptoms: results from a Phase 2b trial

Jaclyn Smith, Elizabeth Ballantyne, Mary Kerr, Lorcan Mcgarvey, Alyn Morice, Mandel Sher, Michael Trower, Stephen Pawsey
European Respiratory Journal 2019 54: PA600; DOI: 10.1183/13993003.congress-2019.PA600
Jaclyn Smith
1University of Manchester, Manchester, United Kingdom
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  • For correspondence: Jacky.Smith@manchester.ac.uk
Elizabeth Ballantyne
2NeRRe Therapeutics Ltd, Stevenage, United Kingdom
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Mary Kerr
2NeRRe Therapeutics Ltd, Stevenage, United Kingdom
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Lorcan Mcgarvey
3Queen’s University Belfast, Belfast, United Kingdom
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Alyn Morice
4Hull York Medical School, Cottingham, United Kingdom
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Mandel Sher
5Center for Cough, Largo, Florida, United States of America
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Michael Trower
2NeRRe Therapeutics Ltd, Stevenage, United Kingdom
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Stephen Pawsey
2NeRRe Therapeutics Ltd, Stevenage, United Kingdom
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Abstract

Background: No proven therapies exist for refractory chronic cough (CC). Neurokinin(NK)-1 antagonists may modulate the central neural hypersensitivity causing CC. The NK-1 antagonist orvepitant was assessed in CC in a Phase 2b dose-ranging study.

Methods: A randomised, controlled, parallel group study recruited subjects with CC ≥1 yr and awake cough count >10/hr. Subjects took placebo (PBO) or one of 3 orvepitant doses (10, 20 or 30mg) once daily for 12-wks. Primary endpoint was awake cough frequency (CF) at Wk-12, using a VitaloJAK ambulatory cough monitor. Other efficacy measures were the patient recorded outcomes (PROs): Leicester Cough Questionnaire (LCQ), Cough Severity (CS) & Urge-to-Cough (UTC) VASs, and global ratings of change (GRoC).

Results: 315 subjects were randomised and 275 were evaluable at Wk-12. Orvepitant 30mg resulted in clinically relevant and significant improvements in PROs in the full analysis set (FAS) at Wk 12: LCQ (PBO-corrected improvement 1.6, p=0.009), CS VAS (9.0mm, p=0.034) and UTC VAS (11.8mm, p=0.005). GRoC scores: for cough severity p=0.054, and frequency p=0.124. The CF endpoint was not significant in the FAS due to an exaggerated PBO response at Wk 12, most evident in the lower CF subjects. In a pre-defined sub-group of higher CF subjects (≥study median awake CF at baseline), a greater efficacy signal is evident with 30mg orvepitant in primary (geometric mean ratio vs PBO 0.71, p=0.066) and secondary efficacy endpoints (e.g. LCQ 1.9, p=0.041), with most being significant despite the study not being powered for sub-group analyses. Orvepitant was safe and well-tolerated.

Conclusions: These data support orvepitant’s further evaluation in CC.

  • Neural pathways
  • Airway management
  • RCT (Randomized Controlled Trial)

Footnotes

Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA600.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2019
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Late Breaking Abstract - The neurokinin-1 receptor antagonist orvepitant improves chronic cough symptoms: results from a Phase 2b trial
Jaclyn Smith, Elizabeth Ballantyne, Mary Kerr, Lorcan Mcgarvey, Alyn Morice, Mandel Sher, Michael Trower, Stephen Pawsey
European Respiratory Journal Sep 2019, 54 (suppl 63) PA600; DOI: 10.1183/13993003.congress-2019.PA600

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Late Breaking Abstract - The neurokinin-1 receptor antagonist orvepitant improves chronic cough symptoms: results from a Phase 2b trial
Jaclyn Smith, Elizabeth Ballantyne, Mary Kerr, Lorcan Mcgarvey, Alyn Morice, Mandel Sher, Michael Trower, Stephen Pawsey
European Respiratory Journal Sep 2019, 54 (suppl 63) PA600; DOI: 10.1183/13993003.congress-2019.PA600
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