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Therapy Trends KOL Insight: Chronic Obstructive Pulmonary Disease [2019]

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Publication Date:
April 2019

How will established brands fare with the advent of new combinations, biologics and new MOAs in COPD?

Bronchodilators and inhaled corticosteroids continue to underpin treatment strategies in COPD, but could new developments improve outcomes? As the dual fixed-combination bronchodilator class becomes increasingly crowded, what will differentiate competitors and could Duaklir have a role? Where will the recently approved triple FDCs, Trelegy and Trimbow, fit in and what impact could the IMPACT and TRIBUTE trials have? Pipeline biologics promise a more targeted approach, but how do KOLs rate the IL-33/ST2 axis targeting agents SAR440340 and RG6149, the anti-GATA3 gene therapy SB010 and the NTHi/Mcat vaccine GSK3277513A? KOLs also assess innovative early-stage assets such as p38 MAPK inhibitor BCT-197, and evaluate whether the new PDE inhibitors RPL554 and CHF6001, can differentiate themselves from Daxas/Daliresp. Twelve of the world’s leading KOLs offer candid insights on these issues and more.

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Top takeaways

  • LAMA therapies have been a cornerstone of the COPD treatment paradigm for decades. With the emergence of new combination therapies, however, how do KOLs anticipate this class will evolve in the next five years?
  • Fixed triple combination therapies (containing dual bronchodilators combined with an inhaled corticosteroid) were first approved in 2017, but what is their impact on prescribers and patients? What advantages do these therapies offer over existing standard-of-care treatments?
  • The dual fixed-combination bronchodilator class is becoming increasingly crowded. What will differentiate competitors and will AstraZeneca/Circassia’s Duaklir have a role?
  • A revision to the influential GOLD treatment guidelines, published in 2019, recommends more selective prescribing of therapies containing inhaled corticosteroids (ICS), based on blood eosinophil concentrations. Do KOLs feel this is a robust and viable biomarker and what impact will the new guidelines have on prescribing practice?
  • In 2018, GlaxoSmithKline published positive results from the landmark Phase III IMPACT study, evaluating triple combination therapy Trelegy against dual combination therapies Relvar/Breo Ellipta and Anoro Ellipta. The study is one of the largest ever in COPD, but what significance do the results have for the COPD treatment paradigm?
  • A number of biologic therapies are currently in Phase II development for maintenance treatment of COPD, but how optimistic are KOLs with regard to these targeted therapies? Does the prior failure in COPD of two anti-IL5 therapies, currently approved for asthma, have implications for any of the biologics currently in development?
  • Mereo BioPharma’s p38 MAP kinase inhibitor BCT-197 (acumapimod) is in development for the treatment of acute exacerbations. What are the current needs in this setting, and could this therapy address them?
  • How do KOLs rate the prospects of the new MOAs in development? Novel MOAs range from vaccines, gene therapies and PDE inhibitors, but do any of them ignite excitement among KOLs? If so, which ones and how could they fare?
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“My best prediction would be, if the PDE story works, then there may be different pathways added on top of standard-of-care double bronchodilation. There may be the ICS pathway, and then maybe the PDE4 pathway, depending on a biomarker.”
EU Key Opinion Leader

“The picture is a little cloudier than it was a couple of years before the triple results were published. The FLAME study demonstrated that LAMA/LABA was superior to ICS/LABA therapy in reducing exacerbations. However, the Trelegy results clearly and convincingly show that the triple is superior to both dual therapies.”
US Key Opinion Leader

Sample of therapies covered

Marketed Therapies

LAMA monotherapies

  • Spiriva (tiotropium; Boehringer Ingelheim)
  • Yupelri (revefenacin; Theravance/Mylan)

LAMA/LABA combinations

  • Duaklir (aclidinium/formoterol; AstraZeneca/Circassia)
  • Bevespi (glycopyrronium/formoterol; AstraZeneca)
  • Stiolto/Spiolto (tiotropium/olodaterol; Boehringer Ingelheim)
  • Ultibro/Utibron (glycopyrronium/indacaterol; Novartis)
  • Anoro (umeclidinium/vilanterol; GSK)

ICS/LABA/LAMA triple combinations

  • Trelegy (fluticasone furoate/vilanterol/umeclidinium; GSK/Innoviva)
  • Trimbow (beclometasone/formoterol/glycopyrronium; Chiesi)

Pipeline Programmes

  • budesonide/formoterol/glycopyrrolate (PT010; AstraZeneca)
  • SAR 440340 (REGN3500; Sanofi/Regeneron
  • RG 6149 (Genentech)
  • SB010 (anti-GATA3 gene therapy; Sterna Biologicals)
  • GSK3277511A (NTHi/Mcat-vaccine; GSK)
  • BCT-197 (acumapimod; Mereo BioPharma)
  • RPL554 (ensifentrine; Verona)
  • CHF6001 (Chiesi)

KOLs interviewed

KOLs from North America

  • Antonio R. Anzueto, Professor, Department of Pulmonary Diseases and Critical Care Medicine, University of Texas Health Science Center, Chief of Pulmonary Section, South Texas Veterans Health Care System, University of Texas, San Antonio, TX
  • Richard Casaburi, Associate Chief for Research in the Division of Respiratory and Critical Care Physiology and Medicine at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine, UCLA, Los Angeles, CA
  • Donald Mahler, Professor of Medicine, Dartmouth Geisel School of Medicine, Hanover, NH
  • Donald P. Tashkin, Professor of Medicine and Director, Pulmonary Function Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, CA
  • Robert Wise, Director of Research, Division of Pulmonary and Critical Care Medicine, Professor of Medicine, Johns Hopkins Hospital, Baltimore, MD

KOLs from Europe

  • Peter J. Barnes, Professor of Thoracic Medicine and Head of Respiratory Medicine at the National Heart and Lung Institute and Honorary Consultant Physician at Royal Brompton Hospital, London, UK
  • Leif Bjermer, Professor and Head of Respiratory Medicine and Allergology, Lund University, Lund, Sweden
  • Kian Fan Chung, Professor of Respiratory Medicine, Royal Brompton Hospital, London, UK
  • Marc Miravitlles, Professor, Chest Physician and Senior Researcher, Department of Pneumology, University Hospital Vall d'Hebron, Barcelona, Spain
  • Nicolas Roche, Professor of Respiratory Medicine at Paris Descartes University and Head of the Department of Respiratory Medicine at Cochin-Broca-Hôtel-Dieu Hospital Group, Paris, France
  • David Singh, Professor, Division of Infection, Immunity & Respiratory Medicine, University of Manchester, University Hospital Of South Manchester NHS Foundation Trust, Manchester, UK
  • Anonymous German KOL, Professor, leading university in Germany, specialising in COPD and respiratory medicine

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