On January 30, Pfizer provided its 2017 financial results along with updates to its pipeline. As anticipated, the pharma giant is cutting out its neurosciences division. However, it also announced ending the development of a few of its early-stage candidates, including a Phase I myeloperoxidase inhibitor for non-alcoholic steatohepatitis (NASH). This move does not mean that Pfizer is scrapping its NASH programme, however. Rather, the company will retain a robust pipeline with three other candidates in active development for NASH.
With an estimated market potential of $25bn sales in 2026 and no currently marketed drugs, NASH has been touted as one of the last untapped blockbuster diseases. On the surface, it may appear that whichever company gets a product to market first can potentially end up with a substantial portion of the market share. However, what is particularly unique and interesting about NASH is that it is a multifactorial disease, which means that a “one drug treats all” strategy may not be effective. Key opinion leaders (KOLs) interviewed by GlobalData have opined that drug combinations with complementary mechanisms of action (MOAs) that target all of the three of the NASH major pathophysiological pathways (the metabolic syndrome, inflammation, and fibrosis) would likely be the best approach to treat the heterogeneous population. Based on this rationale, GlobalData believes that the NASH market will be highly fragmented, with multiple drugs sharing the market potential and best-in-class triumphing over first-in-class.
In addition, several pharmaceutical players in the space have been developing multiple drug candidates with different MOAs with the hope of getting at least one to the market. For example, even after scrapping the myeloperoxidase inhibitor project, Pfizer has three other drugs in its NASH programme: a Phase II acetyl CoA-carboxylase inhibitor, a Phase II ketohexokinase inhibitor, and a Phase I diacylglycerol O-acyltransferase 2 inhibitor. All three candidates target liver fat and, so far, appear to yield promising results. However, the path to commercialisation has remained elusive in NASH given the poorly understood etiology and pathophysiology of the disease, heterogeneous patient populations, dearth of biomarkers, and the need for consensus clinical endpoints. Only time will tell whether the candidates will deliver as intended.