Nonalcoholic Steatohepatitis Drugs Pipeline Analysis 2017

Nonalcoholic steatohepatitis (NASH) is a rare disease of liver characterized by buildup of fat in the liver. Prevalence of nonalcoholic steatohepatitis is increasing parallel to prevalence of obesity across the globe. Nonalcoholic steatohepatitis is caused by insulin resistance and accumulation of toxic lipid metabolites of triglycerides. Several new drugs are being evaluated in clinical trials for the treatment of nonalcoholic steatohepatitis, however, there is no approved drugs available till now. Several molecules are about to complete phase 2 clinical trial and are entering in the most complex phase 3. According to Covance, Inc. survey NASH is the most common liver disease among obesity patients and affects over 60% of the obese population. Cirrhosis due to nonalcoholic steatohepatitis is the third most common cause of liver transplantation in the U.S. The global burden of NASH is increasing every year and there is an urgent need to develop effective treatment for nonalcoholic steatohepatitis. There is a rich pipeline of drugs being studied for nonalcoholic steatohepatitis treatment with huge range of products with different mechanism.

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Nonalcoholic Steatohepatitis Drugs Pipeline: Drivers and Restraints

Growing pace of research activities and stimulation of funding are the factors supporting the growth of pipeline activities in nonalcoholic steatohepatitis treatment. More number of clinical candidates are advancing to late stages of development, which are expected to be launched in the global market within the course of next 8 years. For instance, currently there are four drugs being studied in phase 3 clinical trial, with wide range of mechanisms. Intercept Pharmaceuticals is evaluating its lead molecule- farnesoid X receptor acting agent in metacentric phase 3 trial. Genfit’s Elafibranor has reached phase 3, which is peroxisome proliferator-activated receptor alpha/delta agonist. Two more drugs in phase 3 trial include Tobira Therapeutics’ Cenicriviroc and Gilead’s selonsertib. Failure of these drugs in late stage would cause huge financial losses to the sponsors, which is the biggest risk factor for nonalcoholic steatohepatitis drugs pipeline.

Nonalcoholic Steatohepatitis Drugs: Segmentation

The nonalcoholic steatohepatitis drugs pipeline products are classified on the basis of drug class, mechanism, phases and geography

Based on drug class, nonalcoholic steatohepatitis pipeline drugs are classified in to the following

Drugs Targeting Metabolic Homeostasis
Drugs Acting on Insulin Resistance
Drugs to Prevent and Treat Inflammation
Drugs Preventing Oxidative Stress or Fibrosis
Based on mechanism, nonalcoholic steatohepatitis pipeline drugs are classified in to the following:

Farnesoid X receptor Modulation
Peroxisome proliferator-activated receptor agonist
C chemokine receptor Antagonist
Apoptosis signal-regulated kinase-1 inhibitor
Oral acetyl-CoA carboxylase (ACC) inhibitor
Fibroblast growth factor 21 (FGF 21) inhibitor
Others
Based on development phase, nonalcoholic steatohepatitis pipeline drugs are classified in to the following

Discovery
Preclinical
Phase 1 CT
Phase 2 CT
Phase 3 CT
IND/CTA Filed
Nonalcoholic Steatohepatitis Drugs Pipeline: Overview

There are range of pipeline drugs that target different pathways for synthesis of fatty acid and fibrosis and studies are being conducted to for application of these drugs in combination with existing drugs that are being used for treatment of obesity. There are more than 20 programs that are in phase 2b or phase 2a, which are evaluating candidates for nonalcoholic steatohepatitis treatment. Some of these candidates are performing exceptionally well in clinical trials. For instance, Gilead’s ACC inhibitor GS-0976 showed 43% decrease in hepatic steatosis and 9% reduction in liver stiffness in phase 2

Nonalcoholic Steatohepatitis Drugs Pipeline: Regional Overview

Geographically, the global nonalcoholic steatohepatitis drugs pipeline report is divided into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America dominates the global clinical trial activities in nonalcoholic steatohepatitis treatment with over 200 active clinical trials being carried out in the U.S. and Canada. Western Europe witnesses the second largest magnitude of clinical activities in nonalcoholic steatohepatitis treatment with over 120 active clinical trials. Japan shows low level of research activities in nonalcoholic steatohepatitis.

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Nonalcoholic Steatohepatitis Drugs: Key Players

Some of the key players having nonalcoholic steatohepatitis drugs in their pipeline include Tobira Therapeutics, Inc., Genfit SA, Intercept Pharmaceuticals Inc., Gilead Sciences, Inc., Bristol-Mayers Squibb and Comnay, Merck KGaA, NGM Biopharmaceuticals, Galectin Therapeutics Inc., Madaus Inc. etc. among others.