Skip to main content

Main menu

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • Authors/reviewers
    • Instructions for authors
    • Submit a manuscript
    • Open access
    • COVID-19 submission information
    • Peer reviewer login
  • Alerts
  • Podcasts
  • Subscriptions
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

User menu

  • Log in
  • Subscribe
  • Contact Us
  • My Cart

Search

  • Advanced search
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

Login

European Respiratory Society

Advanced Search

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • Authors/reviewers
    • Instructions for authors
    • Submit a manuscript
    • Open access
    • COVID-19 submission information
    • Peer reviewer login
  • Alerts
  • Podcasts
  • Subscriptions

Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial

Fernando Torres, Harrison Farber, Arsen Ristic, Vallerie McLaughlin, John Adams, Jinkun Zhang, Preston Klassen, William Shanahan, John Grundy, Ines Hoffmann, Christopher Cabell, Pilar Escribano Subías, Namita Sood, Anne Keogh, Gwyn D'Souza, Lewis Rubin
European Respiratory Journal 2019 54: 1901030; DOI: 10.1183/13993003.01030-2019
Fernando Torres
1Pulmonary/Critical Care, UT Southwestern Medical Center, William P. Clements Jr University Hospital, Dallas, TX, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Harrison Farber
2Pulmonary and Critical Care, Boston Medical Center, Boston University, Boston, MA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Arsen Ristic
3Dept of Cardiology, Clinical Center of Serbia and Belgrade University School of Medicine, Belgrade, Serbia
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Vallerie McLaughlin
4Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
John Adams
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jinkun Zhang
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Preston Klassen
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
William Shanahan
6Hessian Pharmaceuticals, Hayward, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
John Grundy
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ines Hoffmann
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher Cabell
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Pilar Escribano Subías
7Dept of Cardiology, Hospital Universitario 12 de Octubre, Complutense University, Madrid, Spain
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Pilar Escribano Subías
Namita Sood
8University of Texas, Houston, TX, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Anne Keogh
9Heart Transplant, St Vincent's Hospital, Sydney, Australia
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gwyn D'Souza
5Arena Pharmaceuticals, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lewis Rubin
10Division of Pulmonary and Critical Care Medicine, University of California, San Diego, CA, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: ljrubin@ucsd.edu
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Abstract

Purpose This phase 2 study was designed to assess the efficacy, safety and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor agonist with a 24-h terminal half-life, compared to placebo in adult patients with symptomatic pulmonary arterial hypertension (PAH).

Methods 61 PAH patients who were receiving standard care, including mono or dual PAH-targeted background therapy were randomised 2:1 to ralinepag (n=40) or placebo (n=21). The starting dose of ralinepag was 10 μg twice daily. Dosage was then up-titrated as tolerated over the course of the 9-week dose-titration period, to a maximum total daily dose of 600 μg (300 μg twice daily). The primary efficacy end-point was the absolute change in pulmonary vascular resistance (PVR) from baseline to week 22. Additional end-points included percentage change in PVR from baseline, other haemodynamic parameters, 6-min walk distance (6MWD) and safety and tolerability.

Results Ralinepag significantly decreased PVR by 163.9 dyn·s·cm−5 compared to an increase of 0.7 dyn·s·cm−5 with placebo (p=0.02); the least-squares mean change from baseline PVR was −29.8% compared with placebo (p=0.03). 6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90). Serious adverse events occurred in 10% of ralinepag patients and 29% of placebo patients. Study discontinuations occurred in 13% of ralinepag patients and 10% of placebo patients.

Summary Ralinepag reduced PVR compared with placebo in PAH patients on mono (41%) or dual combination (59%) background therapy.

Abstract

In this 22-week randomised, placebo-controlled phase 2 study of PAH patients on single or dual oral background therapy, ralinepag, an oral IP receptor agonist, significantly reduced PVR. http://bit.ly/2XHSccO

Footnotes

  • This study is registered at clinicaltrials.gov with identifier NCT02279160. The study protocol and statistical analysis plan are available on the clinicaltrials.gov website. The database for this clinical trial is the sole property of the sponsor, which has sole authority for the provision of access.

  • Support statement: This study was sponsored by Arena Pharmaceuticals, Inc. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Conflict of interest: F. Torres reports grants from UT Southwestern Medical Center, during the conduct of the study.

  • Conflict of interest: H. Farber has nothing to disclose.

  • Conflict of interest: A. Ristic has nothing to disclose.

  • Conflict of interest: V. McLaughlin has nothing to disclose.

  • Conflict of interest: J. Adams

  • Conflict of interest: J. Zhang is an employee of Arena Pharmaceuticals.

  • Conflict of interest: P. Klassen is an employee of Arena Pharmaceuticals.

  • Conflict of interest: W. Shanahan is a former employee of Arena Pharmaceuticals and hold shares.

  • Conflict of interest: J. Grundy is an employee of Arena Pharmaceuticals.

  • Conflict of interest: I. Hoffmann is an employee of Arena Pharmaceuticals.

  • Conflict of interest: C. Cabell is an employee of Arena Pharmaceuticals

  • Conflict of interest: P. Escribano-Subias has nothing to disclose.

  • Conflict of interest: N. Sood reports grants for research from The Ohio State University, during the conduct of the study.

  • Conflict of interest: A. Keogh has nothing to disclose.

  • Conflict of interest: G. D'Souza reports personal fees (consulting and travel) from Arena, outside the submitted work.

  • Conflict of interest: L. Rubin has nothing to disclose.

  • Received January 24, 2019.
  • Accepted June 18, 2019.
  • Copyright ©ERS 2019
https://www.ersjournals.com/user-licence
View Full Text
PreviousNext
Back to top
View this article with LENS
Vol 54 Issue 4 Table of Contents
European Respiratory Journal: 54 (4)
  • Table of Contents
  • Index by author
Email

Thank you for your interest in spreading the word on European Respiratory Society .

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial
(Your Name) has sent you a message from European Respiratory Society
(Your Name) thought you would like to see the European Respiratory Society web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Print
Citation Tools
Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial
Fernando Torres, Harrison Farber, Arsen Ristic, Vallerie McLaughlin, John Adams, Jinkun Zhang, Preston Klassen, William Shanahan, John Grundy, Ines Hoffmann, Christopher Cabell, Pilar Escribano Subías, Namita Sood, Anne Keogh, Gwyn D'Souza, Lewis Rubin
European Respiratory Journal Oct 2019, 54 (4) 1901030; DOI: 10.1183/13993003.01030-2019

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

Share
Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial
Fernando Torres, Harrison Farber, Arsen Ristic, Vallerie McLaughlin, John Adams, Jinkun Zhang, Preston Klassen, William Shanahan, John Grundy, Ines Hoffmann, Christopher Cabell, Pilar Escribano Subías, Namita Sood, Anne Keogh, Gwyn D'Souza, Lewis Rubin
European Respiratory Journal Oct 2019, 54 (4) 1901030; DOI: 10.1183/13993003.01030-2019
del.icio.us logo Digg logo Reddit logo Technorati logo Twitter logo CiteULike logo Connotea logo Facebook logo Google logo Mendeley logo
Full Text (PDF)

Jump To

  • Article
    • Abstract
    • Abstract
    • Introduction
    • Methods
    • Results
    • Discussion
    • Shareable PDF
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
  • Info & Metrics
  • PDF

Subjects

  • Pulmonary vascular disease
  • Tweet Widget
  • Facebook Like
  • Google Plus One

More in this TOC Section

Original Articles

  • Systematic assessment of respiratory health in illness susceptible athletes
  • Identifying early PAH biomarkers in systemic sclerosis
  • Viable virus aerosol propagation by PAP circuit leak
Show more Original Articles

Pulmonary hypertension

  • Mild PH and premature mortality in a cohort undergoing routine echocardiography
  • Whipple’s disease: a rare and life-threatening cause of pulmonary hypertension
  • Patterns of pulmonary hypertension in Egyptian patients with COPD: A retrospective analysis
Show more Pulmonary hypertension

Related Articles

Navigate

  • Home
  • Current issue
  • Archive

About the ERJ

  • Journal information
  • Editorial board
  • Reviewers
  • Press
  • Permissions and reprints
  • Advertising

The European Respiratory Society

  • Society home
  • myERS
  • Privacy policy
  • Accessibility

ERS publications

  • European Respiratory Journal
  • ERJ Open Research
  • European Respiratory Review
  • Breathe
  • ERS books online
  • ERS Bookshop

Help

  • Feedback

For authors

  • Instructions for authors
  • Publication ethics and malpractice
  • Submit a manuscript

For readers

  • Alerts
  • Subjects
  • Podcasts
  • RSS

Subscriptions

  • Accessing the ERS publications

Contact us

European Respiratory Society
442 Glossop Road
Sheffield S10 2PX
United Kingdom
Tel: +44 114 2672860
Email: journals@ersnet.org

ISSN

Print ISSN:  0903-1936
Online ISSN: 1399-3003

Copyright © 2022 by the European Respiratory Society