As fatty liver disease prevalence soars, pharma companies look to first-in-class drugs

Due to the increasing global prevalence of fatty liver disease (FLD), which comprises a spectrum of chronic liver disorders characterized by excessive lipid accumulation in the liver (steatosis), potentially leading to inflammation (steatohepatitis) and fibrosis, pharmaceutical companies are looking to first-in-class treatments to help to address increasingly urgent unmet needs, according to business intelligence provider GBI Research.

The company’s latest report states that FLD is the most common chronic liver disease in the world. Its global prevalence has increased rapidly in the past several decades and is now estimated at 20-45% in the general population, 70% in diabetic patients, and 50-90% in obese people.

Jennifer Goossens, Associate Analyst for GBI Research, explains: “Although FLD is increasingly recognized as a major global health problem, the treatment market is still in its infancy, with no FDA-approved drugs and only a small number of generic drugs approved in certain European and Asia-Pacific markets in recent years. These include the antioxidative and antifibrotic drugs silibinin and ursodiol.

“Lifestyle changes and reduction of body weight are the primary recommendations to control FLD, while liver transplantation is the only definitive option for patients with severe disease, meaning there is an urgent unmet need to develop safe pharmacologic therapies.”

Due to the pathophysiological complexity of FLD and its diverse population, different therapeutic agents are likely to be needed in order to tackle the lipotoxic, inflammatory and fibrogenic effects seen in FLD. The treatment pipeline is relatively large, with 173 products in active development and a sizeable proportion of first-in-class drugs.

Goossens continues: “The degree of first-in-class innovation is 15% above the industry average, which is very promising considering the level of unmet need and lack of approved treatment options. Furthermore, a high proportion of first-in-class products with no prior involvement in licensing or co-development deals have been identified, which demonstrates that there are strong investment opportunities for first-in-class product development within the FLD landscape.

“The majority of these products are small molecules in the early drug development stages. They also target a range of first-in-class molecular targets, with several different molecular target classes represented. This provides diverse opportunities for potential investors.”