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Reportlinker Adds R&D Trends: Autism Spectrum Disorders - Unknown Etiology and Low Industry Interest Hinders Pipeline Progression


News provided by

Reportlinker

Apr 28, 2011, 06:38 ET

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NEW YORK, April 28, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

R&D Trends: Autism Spectrum Disorders - Unknown etiology and low industry interest hinders pipeline progression

http://www.reportlinker.com/p0487107/RD-Trends-Autism-Spectrum-Disorders---Unknown-etiology-and-low-industry-interest-hinders-pipeline-progression.html

Introduction

Since 2006, two drugs have gained FDA approval for the symptomatic treatment of irritability in autism spectrum disorders (ASDs). However, the pipeline is also characterized by a high attrition rate, with eight pipeline candidates having been discontinued since 2009. CureMark's Phase III candidate, CM-AT, currently represents the most advanced compound in the small ASD pipeline.

Features and benefits

* Overview of drugs in late- and early-stage clinical development for autism spectrum disorders.

* Identification of the target product profile for future autism spectrum disorders treatments.

* Summary of clinical trial design in autism spectrum disorders including exploration of key endpoints and assessment methodology.

* Identification of key challenges associated with the conduct of clinical trials in autism spectrum disorders.

* Exploration of the future treatment in autism spectrum disorders including the development of personalized treatments and the use of biomarkers.

Highlights

The autism spectrum disorders (ASDs) pipeline is sparse relative to other conditions that are treated with psychotropic medications. The unknown etiology of ASDs poses a fundamental challenge to the therapeutic discovery process and the pipeline is characterized by a high attrition rate.

The two approved therapies for the management of autism spectrum disorders both target the symptoms of irritability. The comparator therapy identified by Datamonitor is Risperdal (risperidone; Johnson & Johnson) as it was the first to be approved in this indication, demonstrates a strong efficacy profile and is regarded as a first-line therapy.

Key challenges associated with the conduct of clinical trials in autism spectrum disorders are: the unknown etiology of the disorders and heterogeneous symptomology. Communication and language impairments commonly associated with autism spectrum disorders further compound these challenges.

Your key questions answered

* How many drugs are in clinical development for the treatment of autism spectrum disorders? What deters companies from investing in this area?

* What symptoms and mechanisms of action are most frequently targeted? What key companies are involved in the pipeline?

* What is the target product profile and most appropriate comparator therapy?

* What are the key challenges in the conduct of clinical trials in autism spectrum disorders?

* How is the treatment of autism spectrum disorders likely to evolve over the next 10 to 20 years?

Executive Summary

Strategic scoping and focus

Datamonitor key findings

Related reports

OVERVIEW

Catalyst

Summary

CLINICAL PIPELINE OVERVIEW

Overview of the autism spectrum disorders pipeline

The autism spectrum disorders pipeline is sparse, comprising just four compounds in clinical development

Emerging features of the autism spectrum disorders clinical pipeline

Classification of pipeline products

Each of the four pipeline candidates targets a different mechanism of action

Companies involved in the autism spectrum disorders clinical pipeline

Pipeline activity is limited to small, specialist pharmaceutical companies

Late-stage development compounds recently discontinued

Pipeline failures prevalent due to unknown etiology of autism spectrum disorders

TARGET PRODUCT PROFILE

Clinical targets

Clinical trial data indicate a lack of efficacy of investigated therapies

Although superior to Risperdal, side effects are also prominent with Abilify treatment

Ease of administration is a key consideration in the development of treatments for the pediatric population

Comparator therapy: Risperdal (risperidone; Johnson & Johnson)

Risperdal was the first drug to receive FDA approval for irritability associated with autistic disorder

Clinical trial data for Risperdal

Target product profile versus current level of attainment

Target product for the treatment of irritability should demonstrate superior efficacy and side effect-profile to Risperdal

CLINICAL TRIAL DESIGN IN AUTISM SPECTRUM DISORDERS

Use of clinical trial endpoints varies according to the target behavioral symptom

Core symptoms

Repetitive behavior

Irritability

ADHD symptoms

Social impairment

Typical clinical trial design

Key challenges in the conduct of clinical trials in autism spectrum disorders

Unknown etiology of autism spectrum disorders hinders selection of appropriate targets

Heterogeneity of symptomatology complicates patient subgroup identification

Conduct of trials in children and young adolescents is complicated by communication difficulties

Future developments in clinical trial design

Clinical trials are likely to include adult autism spectrum disorder patients in the future

Increased patient selection will help to increase response rates in clinical trials

INNOVATIVE EARLY-STAGE APPROACHES

Scientific rationale determines targets, but clinical efficacy needs to be demonstrated

Directly reducing glutamate transmission holds promise, but more trials are required

Consequence of low insulin-like growth factor levels in autism spectrum disorders is unknown

Efficacy will need to be particularly high to outweigh safety concerns associated with stem cell treatment

THE FUTURE OF TREATMENT IN AUTISM SPECTRUM DISORDERS

Continued research into the etiology of ASDs is essential for development of treatments

Elucidating the genetic and environmental interactions will aid treatment discovery

Biomarkers will aid the development of personalized treatment options

Promise for identification, earlier intervention, and treatment response

Subpopulation stratification will increase treatment response

BIBLIOGRAPHY

Journal papers and publications

Websites

Datamonitor reports

APPENDIX

Contributing experts

Conferences attended

Report methodology

To order this report:

: R&D Trends: Autism Spectrum Disorders - Unknown etiology and low industry interest hinders pipeline progression

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

CONTACT:
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker

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