R&D Trends: Alzheimer’s Disease – Pipeline growth undeterred by high-profile failures

Published by: Datamonitor

Published: Mar. 23, 2012 - 54 Pages


Table of Contents

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Overview of the Alzheimer’s disease pipeline
Datamonitor has identified 102 separate programs in clinical development
Emerging features of the Alzheimer’s disease pipeline
Changes in pipeline dynamics
Companies involved in the Alzheimer’s disease pipeline
Discontinued pipeline drugs in Alzheimer’s disease
30 distinct Alzheimer’s disease projects have been discontinued at the clinical stage since 2010
The vast majority of discontinuations occur during early-stage testing
Candidates targeting neurotransmitter pathways were the most commonly discontinued drugs
Numerous factors contribute to the pronounced attrition rate in the Alzheimer’s disease pipeline
TARGET PRODUCT PROFILE
Comparator therapies
Aricept (donepezil; Eisai/Pfizer)
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN ALZHEIMER’S DISEASE
Clinical trials
Commonly used clinical trial endpoints for Alzheimer’s disease
Biomarker endpoints
Typical trial design
Future developments in clinical trial design
Improving the likelihood of success in Alzheimer’s disease clinical trials
Demonstrating disease modification through clinical trials
INNOVATIVE EARLY-STAGE APPROACHES
GSK-3 beta inhibition
GSK-3 is implicated in multiple facets of Alzheimer’s disease pathogenesis
The target is now attracting interest in the wider pharmaceutical industry
Glutaminyl cyclase (QC) inhibition
Pyroglutamate-modified beta amyloid is highly neurotoxic
The formation of pyroglutamate can be blocked through inhibition of glutaminyl cyclase
Passive immunotherapy can also be used against pyroglutamate beta amyloid
Retinoid X receptor agonism
Encouraging result in mice study reveals the potential of retinoid X receptor agonists to increase amyloid clearance
THE FUTURE OF TREATMENT IN ALZHEIMER’S DISEASE
Biomarkers and early diagnosis
Diagnostic biomarkers in development
The goal of diagnostic biomarkers is to facilitate an Alzheimer’s diagnosis prior to the onset of dementia
There are notable caveats to consider before widespread use can be contemplated
A future scenario might involve screening the adult population for Alzheimer’s disease risk
Disease-modifying drugs
2013 could be a breakthrough year for Alzheimer’s disease treatment
Disease-modifying drugs may have greater potential in early or presymptomatic Alzheimer’s disease
Prophylactic treatment to stop conversion to dementia is the ultimate goal
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
PharmaVitae Explorer database
Contributing experts
Conferences attended
Report methodology

Abstract

Introduction

The number of products in development for Alzheimer’s disease is greater than ever, despite the pipeline’s inability to produce a new chemical entity since Namenda in 2002. However, with Pfizer, Johnson & Johnson, and Eli Lilly set to release results for pivotal Phase III trials of bapineuzumab and solanezumab from Q3 2012, the Alzheimer’s community may soon be heralding much-needed breakthroughs.

Features and benefits
  • Understand key dynamics in the R&D pipeline for new Alzheimer’s disease therapies.
  • Benchmark novel and existing therapies using the target product profile identified by Datamonitor.
  • Support R&D decision making by evaluating current and future Alzheimer’s disease clinical trial designs.
  • Evaluate the most promising new pharmacological targets in early-stage development.
  • Access Datamonitor's prediction of how the treatment landscape may change in the next 20 years.
Highlights

The vast majority of products in clinical development are in either Phase I or Phase II, while just six drugs are in Phase III trials or pending approval and launch. The huge disparity between the number of drugs in Phase II and Phase III highlights the problem in developing novel therapies for Alzheimer’s disease.Biomarker tests can be used to effectively enrich the population of a clinical trial, increasing the likelihood of success. Furthermore, biomarker endpoints can be a useful way of measuring the effect that a potentially disease-modifying drug has on the Alzheimer’s disease pathology that it targets.Diagnostic biomarkers can potentially be used to identify patients with MCI due to Alzheimer’s disease. Such a diagnosis is useful as there are steps that can be taken to slow the progression to dementia. If effective disease-modifying agents are available, drug treatment at this stage could also be used as a preventative intervention.

Your key questions answered
  • What are the key trends in the Alzheimer’s disease pipeline?
  • How has the pipeline evolved in the past 5 years?
  • What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?
  • What role are biomarkers playing in Alzheimer’s disease diagnosis and clinical trials?
  • How will the advent of early diagnosis and disease-modifying drugs change the future treatment landscape?


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