Frontier Pharma: Fatty Liver Disease - High Degree of First-in-Class Innovation, Dominated by Nuclear Receptor-Targeting NASH Products

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Fatty liver disease (FLD) comprises a spectrum of chronic liver disorders characterized by excessive lipid accumulation in the liver (steatosis), which may lead to inflammation (steatohepatitis) and fibrosis. It has the potential to progress to end-stage liver diseases such as cirrhosis, liver cancer and liver failure, and is also associated with numerous complications and co-morbidities, including cardiovascular and metabolic diseases. FLD can be divided into non-alcoholic FLD (NAFLD) and alcoholic FLD (AFLD), depending on the patent’s history of alcohol use.

FLD is the most common chronic liver disease in the world, and its global prevalence has increased rapidly in the past several decades. The worldwide prevalence of FLD is estimated at 20–45% in the general population, and up to 90% in obese patients. There is a broad consensus to describe the condition as the hepatic manifestation of metabolic syndrome, and it is closely associated with obesity, diabetes and dyslipidemia. NAFLD has become the main driver of the rapid growth of FLD prevalence, mainly due to the rising prevalence of obesity.

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FLD is increasingly recognized as a major global health problem. However, despite this the FLD market is still in its infancy, with no FDA-approved drugs for this indication, and only a limited number of generic drugs approved in non-US markets in recent years.

Due to the increasing health burden of FLD and the lack of therapeutic options, there is a pressing need to develop pharmacological strategies. This is especially the case for patients with steatohepatitis, who are at the greatest risk of developing cirrhosis or liver cancer, which can lead to liver failure. Due to the pathophysiological complexity of FLD and its diverse population, different therapeutic agents are likely to be needed to tackle the lipotoxicity, inflammation and fibrogenesis that drive FLD progression.

FLD has an active pipeline and first-in-class products account for a considerable proportion, which is very promising considering the level of unmet need and lack of approved treatment options. First-in-class innovation is concentrated heavily at the early drug development stages, and prominent first-in-class molecular targets include nuclear receptors, immune mediators, and molecules involved in lipid synthesis. Additionally, the first-in-class targets identified show considerable diversity, reflecting the multifaceted aspects of FLD pathophysiology.

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Table of Contents

1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 5
2.1 Urgent Unmet Need Driven By Rising Prevalence 5
2.2 High Degree of First-in-Class Innovation 5
2.3 Rising Deal Volumes and Considerable Investment Opportunities in First-in-Class Product Development 5

3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Disease Symptoms 11
4.3 Epidemiology 11
4.4 Etiology and Risk Factors 11
4.4.1 Environmental Factors 11
4.4.2 Host Factors 12

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