R&D Trends: Asthma – Extensive investment in novel targets

Published by: Datamonitor

Published: Apr. 17, 2012 - 44 Pages


Table of Contents

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Wide variation of targets in the pipeline
Numerous oral products in development
Xolair mechanism of action
Development compounds recently discontinued
TARGET PRODUCT PROFILE
Advair (fluticasone/salmeterol; GlaxoSmithKline)
Xolair (omalizumab; Genentech/Novartis)
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN ASTHMA
Clinical trial design
Active comparators
Trial duration
Patient selection
Clinical trial endpoint measures
Typical Phase III development program in asthma
Future developments in clinical trial design
LABA safety studies required in the US
INNOVATIVE EARLY-STAGE APPROACHES
CRTH2 antagonists represent a large proportion of drugs in early-stage development
Biologics are making their way through the pipeline
THE FUTURE OF TREATMENT IN ASTHMA
Simplified treatment expected in the medium and long term
Novel targeted therapies for niche patient groups
BIBLIOGRAPHY
Journal papers
Websites
APPENDIX
Contributing experts
Conferences attended
Report methodology

Abstract

Introduction

Datamonitor identified 139 products in development for asthma in 2012. In the near term Datamonitor expects that there will be little change in treatment regimens but strong innovation is seen in earlier stages and Datamonitor expects that novel targeted therapies could make their way through the pipeline, aimed at niche patient groups.

Features and benefits
  • Support R&D decision-making by understanding what is driving development in the pipeline.
  • Analyze clinical trial design to understand how the desired indication impacts endpoint choice.
  • Assess novel early-stage approaches and the future of treatment in asthma, with insight from key opinion leaders.
  • Benchmark pipeline candidates using the ideal target product profile identified by Datamonitor.
Highlights

Datamonitor identified 139 products in development for asthma. Earlier stages in particular show significant diversity with numerous targets under investigation. Many of these will fail to progress through the pipeline, but those that do could offer a novel treatment option. These will be particularly important for patients with refractory asthma.Lung function measures have been used extensively in clinical trials for asthma. However, clinical trials for biologics in asthma should have a different focus. AstraZeneca’s current Phase IIb trial of tralokinumab has a primary endpoint of asthma exacerbations over 52 weeks.Severe asthma remains a significant cause of mortality and morbidity and a portion of patients remain inadequately controlled despite combination treatment. Few innovations have been seen recently in asthma, despite significant research and numerous proposed targets. Still, strong investments continue, and novel therapies could reach the market.

Your key questions answered
  • How does the late-stage pipeline differ from early stages and what is driving investment in asthma R&D?
  • How does clinical trial design differ between drug classes and what lessons have been learned from trials of biologics?
  • Which early-stage approaches are the most promising and how will they change future treatment?
  • What would it take for a pipeline candidate to see success in the highly penetrated asthma market?


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