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Breakthroughs in Non-Alcoholic Steatohepatitis Management

  • Report

  • 46 Pages
  • March 2019
  • Region: Global
  • Frost & Sullivan
  • ID: 4761503

Multiple Investigational New Drugs With High Potential for Better Treatment Outcomes Progressing Through Critical Stages of Clinical Development

Non-Alcoholic Steatohepatitis or NASH is a liver disorder that is characterized by the build-up of fat in liver in addition to inflammation and liver cell damage eventually progressing to cirrhosis. Currently lifestyle interventions are suggested for the treatment of NASH with no drugs having been approved for the condition.

Multiple drugs are at the last stages of clinical trials with promising interim results while many more drugs are in early and mid-phase of clinical studies. Until now with no drugs approved for the condition of non-alcoholic steatohepatitis, there existed a huge unmet medical need.

Poor performance of INDs tested for the condition of non-alcoholic steatohepatitis over the years has been attributed to poor preclinical models which has led to poor human translation of drug safety and efficacy in addition to use of conservative biomarkers during clinical trials.

If companies can truly overcome the challenge of human translation of drug potential in terms of efficacy and safety, then non-alcoholic steatohepatitis as a manageable condition would be conquered within the next decade.

The United States leads the way in the number of NASH-related patents published. The major challenge to demonstrate translation of clinical endpoint data in NASH trials has been to stop the disease progression to cirrhosis.

Table of Contents

1.0 Executive Summary
1.1 Research Objectives
1.2 Research Methodology
1.3 Key Findings
2.0 Non-Alcoholic Steatohepatitis (NASH): an Introduction
2.1 NASH Is A Progressive Form Of Non-alcoholic Fatty Liver Disease
2.2 Currently There Are No Treatments Available For NASH
2.3 NASH Has No Successfully Approved Drug On The Market
3.0 NASH: Novel Drug Development Process
3.1 New Biomarker Discoveries Have Led To Development Of Multiple INDs
3.2 Factors Affecting Clinical Trial Success Of NASH Candidates
3.3 A High Number Of Clinical Candidates Target Farnesoid X Receptor
4.0 Clinical Development Landscape of INDs for Treatment of NASH
4.1 A Steady Stream of INDs have Entered Phase 1 Trial Over Last 5 Years
4.2 Pfizer Maintains a Strong Portfolio of Inds for NASH Treatment
4.3 Currently, the Highest Number of Inds are at Phase 2 Studies
4.4 Highest Number of Inds for NASH have Failed at Phase 2 Clinical Trials
4.5 MGL-3196 Is One of the most Promising Candidates for NASH
4.6 Phase 2 Studies also see the most Number of Study Terminations
4.7 Three Inds are Expected to Seek Fda-approval By 2020
4.8 Almost all INDs in Phase 3 are on Fast-track or Breakthrough Designation
5.0 Comparative Study Of Selected Clinical Candidates
5.1 Comparison of 4 Promising Clinical Candidates for NASH
6.0 Patent Landscape Assessment
6.1 Patent Research Scope And Concepts
6.2 Top 10 Patent Holding Companies in NASH
6.3 Top 10 Patent Holding Educational Institutes in NASH
6.4 Office-wise Distribution of Patent Portfolio, 2008-2018*
6.5 Year-wise Distribution of NASH Patent Publication Portfolio, 2008–2018*
6.6 Organism-wise Distribution of NASH Patent Publication Portfolio, 2008–2018*
7.0 Research Innovation Profiles
7.1 Academic Collaborations Bear Fruit for Pharma Companies
7.2 Innovative Drugs in the NASH Pipeline
7.3 Better Disease Models To Improve Human Translation Of Drugs
8.0 Growth Opportunities
8.1 Growth Opportunity 1: Drug Approval for Treatment of NASH
8.2 Growth Opportunity 2: Better Preclinical Models for NASH
8.3 Growth Opportunity 3: Use of Biomarkers in Clinical Trials
9.0 Appendix
9.1 Key Contacts

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Pfizer