R&D Trends: COPD – Simplified therapies are gaining traction

Published by: Datamonitor

Published: Mar. 14, 2012 - 50 Pages


Table of Contents

Executive Summary
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Bronchodilators dominate late-stage pipeline
Innovation seen in early stages of the pipeline
Bronchodilator mechanism of action
PDE4 inhibition in COPD
Late-stage development compounds recently discontinued
TARGET PRODUCT PROFILE
Current gold standard and comparator therapies
Spiriva is the gold-standard monotherapy in COPD
Advair is the most commonly used fixed-dose combination in COPD
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN COPD
Clinical trials
Clinical endpoints
Active comparators
Trial duration
Patient selection
Typical Phase III development program in COPD
Future developments in clinical trial design
INNOVATIVE EARLY-STAGE APPROACHES
Dual-acting bronchodilators
Triple therapies are the logical next step
Novel targeted therapies may help move towards specialized medicine
THE FUTURE OF TREATMENT IN COPD
Pulmonologists expectations for COPD treatment in 2016
Spiriva to remain widely used across disease severities
Fixed-dosed combination therapy to simplify treatment
BIBLIOGRAPHY
Journal papers
Websites
APPENDIX
Contributing experts
Conferences attended
Primary research
Report methodology

Abstract

Introduction

Datamonitor identified 109 products in development for COPD in 2012. Later stages of the pipeline are made up of familiar classes for COPD, or combinations thereof, with four LABA/LAMA combinations in Phase III. Earlier stages of the pipeline show more diversity, with numerous novel anti-inflammatory therapies seen in preclinical and Phase I development.

Features and benefits
  • Support R&D decision making by understanding the competitive dynamics of the pipeline.
  • Analyze clinical trial design, with a focus on how companies can use endpoints to differentiate their products.
  • Assess novel early-stage approaches and the future of treatment in COPD, with insight from key opinion leaders.
  • Benchmark pipeline candidates using the ideal target product profile identified by Datamonitor.
Highlights

Datamonitor identified 109 products in development for COPD. Combination bronchodilators are widely anticipated as they may improve compliance and efficacy. Other novel combinations are seen in earlier stages of the pipeline, including dual-acting muscarinic antagonist beta 2 agonists and triple therapies.The majority of Phase III trials in COPD focus on lung function, but increasingly trials focused on exacerbation rates are seen. Furthermore, mortality can be used as an endpoint, and as no drug has yet been shown to conclusively reduce mortality in COPD, demonstrating such an effect would be a strong advantage.There remains a strong need for novel treatments in COPD and effective anti-inflammatory therapies are expected to reduce exacerbations and improve symptoms and health status. The recent approval of the first PDE4 inhibitor for COPD, Daliresp (roflumilast; Nycomed), provides encouragement for investment in additional novel anti-inflammatories.

Your key questions answered
  • Which late-stage pipeline candidates are likely to impact COPD treatment in the near term?
  • How are companies using clinical trials to differentiate their products for greater commercial success?
  • Which early-stage approaches are the most promising and how will they change future treatment?
  • Is there value in novel anti-inflammatories or will current therapies resist pipeline competition?


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